Clinical trial NCT05507970
Conditions: Malaria,Falciparum
Keywords: Malaria Healthy Volunteers
Sponsor: Medicines for Malaria Venture
Start date: 2022-07-29; Completion date: 2023-01-25
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.

In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.

In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.

In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.

Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.

Detailed description:
Part 1 will be a double-blinded, randomised, placebo-controlled, single ascending dose (SAD) study, which will comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E will be optional), with 8 participants in each cohort. Participants will be randomly assigned to receive a single oral dose of either active IMP (investigational medicinal product) (6 participants) or placebo (2 participants) to assess its safety, tolerability and PK (pharmacokinetic) profile. Each participant will take part in one cohort. Cohort A dose is 100mg. Doses for cohorts B to E will be determined following a blinded interim review of the safety, tolerability and PK data after each cohort, prior to the dose decision for subsequent cohorts.

Part 2 will be an open-label, randomised, balanced two-period crossover, food effect evaluation. It is planned to enrol 8 participants. In Period 1, participants will be randomised to 1 of 2 treatment sequences. If a participant is randomised to receive MMV367 in the fasted state in Period 1, they will receive MMV367 in the fed state in Period 2 and vice versa. The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of MMV367 and a safe exposure window has been established in Part 1.

Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A total of 8 participants per cohort (A-C) will receive once-daily doses of MMV367 (6 participants) or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability and PK profile of multiple dosing. Cohorts 3B and 3C are optional and may proceed after a review of the safety and PK data. The dose(s) administered in Part 3 will be determined after review of the data from Part 1.

Parts 1 and 3 will follow a sentinel dosing design. For each of the three parts, participants will be screened within 28 days prior to first admission to the clinical unit on the morning of Day -1.

Part 1: In each cohort, participants will be dosed on Day 1 and will remain resident in the clinical unit until discharge on Day 5. They will attend the clinical unit for a return visit on Day 7 and again on Day 15 for end of study assessments.

Part 2: Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and will remain resident in the clinical unit until discharge on Day 12. They will attend the clinical unit on Day 14 for end of study assessments. Based on emerging PK data from Part 1, the washout period between the Period 1 and Period 2 doses may be extended.

Part 3: Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on Day 9 and again on Day 17 for end of study assessments.

For all parts, blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study.

Arms: arm 1: 100 mg MMV367, oral solution, fasted, arm 2: Single ascending dose to be determined after SAC (Safety Advisory Committee) review of previous cohort.

Intervention: MMV367, oral solution, fasted arm 3: Single ascending dose to be determined after SAC review of previous cohort.

Intervention: MMV367, oral solution, fasted arm 4: Single ascending dose to be determined after SAC review of previous cohort.

Intervention: MMV367, oral solution, fasted arm 5: Single ascending dose to be determined after SAC review of previous cohort.

Intervention: placebo, oral solution, fasted arm 6: Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.

MMV367: Single dose dispersed in sterile water. arm 7: Double-blinded, randomised, placebo-controlled, multiple-dose study.

Intervention: MMV367 oral solution, fasted. Once daily for 3 days. arm 8: Double-blinded, randomised, placebo-controlled, multiple-dose study.

Intervention: placebo, oral solution, fasted. Once daily for 3 days arm 9: Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
Interventions: intervention 1: MMV367 intervention 2: Placebo intervention 3: MMV367 (Fed 440mg) intervention 4: MMV367 intervention 5: Placebo intervention 6: MMV367 (Fasted 440mg)
Intervention descriptions: intervention 1: Single dose dispersed in sterile water, fasted. intervention 2: Single Dose dispersed in sterile water, fasted. intervention 3: Single dose dispersed in sterile water with a high fat meal. intervention 4: Single dose dispersed in sterile water, fasted, administered for 3 consecutive days. intervention 5: Single dose dispersed in sterile water, fasted, administered for 3 consecutive days. intervention 6: Single dose dispersed in sterile water fasted.

Protocol documents:
Prot_000.pdf: 
Doc No:DOC-87929                         Doc Name:QSC207031 Clinical Protocol
Project Number:207031                             Version:3.0                             
Status:Approved
Governing SOP: DOC-02642
CLINICAL STUDY PROTOCOL
A First-in-Human, Single-Centre, Single Ascending Dose, 
Multiple Dose and Pilot Food Effect Study to Assess the Safety, 
Tolerability and Pharmacokinetics of MMV367 in Healthy 
Participants
Short Study Title: First-in-Human Study to Assess the Safety, 
Tolerability and Pharmacokinetics of MMV367
Quotient Sciences Study Number:
QSC207031
Sponsor Study Number:
MMV_MMV367_21_01
EudraCT Number:
2022-000918-33
Clinical Study Site:
Quotient Sciences
Mere Way
Ruddington Fields
Ruddington
Nottingham NG11 6JS, UK
Tel: +44 (0)115 974 9000
Sponsor:
Medicines for Malaria Venture
ICC - Block 3, 3rd Floor
20 Route de Pré-Bois 
PO Box 1826
1215 Geneva 15 
Switzerland
Tel. +41 22 555 03 00
Date of Protocol:
08 Sep 2022
Status of Protocol:
Version 3.0
SPONSOR/QUOTIENT SCIENCES CONFIDENTIAL
This clinical protocol may not be reproduced or communicated to a third party 
without the written permission of Medicines for Malaria Venture.
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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Protocol MMV_MMV367_21_01 (QSC207031) Version 3.0 
 08 SEP 2022 
Page 2 of 92  
 
Document History 
Protocol Version Number 
Classification 
Date  
3.0 
Non-substantial Amendment 
08 Sep 2022 
2.0 
Update following feedback from 
the regulatory authorities 
01 Jun 2022 
1.0 
Original Protocol 
28 Apr 2022 
 
Details of the amendment above can be found in Appendix 10. 
 
 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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Protocol MMV_MMV367_21_01 (QSC207031) Version 3.0 
 08 SEP 2022 
Page 3 of 92  
 
Study Contacts 
Principal Investigator: 
Nand Singh BSc, MD, DPM, MFPM 
Quotient Sciences 
Mere Way 
Ruddington Fields 
Ruddington 
Nottingham NG11 6JS, UK 
Tel: +44 (0)115 974 9000 (day) 
Tel: +44 (0)7774 017236 (out of hours emergency) 
Sub-Investigators: 
Sharan Sidhu MBChB, BAO, MRCS, MFPM 
Philip Evans MBChB, MRCS (Ed) 
Stuart Mair MBChB, DRCOG, DCPSA, FFPM 
Somasekhara Menakuru MBBS, MS, MRCS, DPM, 
MFPM 
Litza McKenzie MBChB, BScMedSci (Hons) 
Martina Fieldingova MUDr 
Elizabeth Maria van Niekerk MBChB, DipPalMed 
David Everton BSc, MBBS 
Anisha Sharma, MBBS, MRCGP 
Courtney Krstic BMedSci, BMBS (Hons) 
Lena Chen BSc (Hons), MBBS, MRCGP 
Nicholas Akam BMedSci, BMBS, MRCGP 
Quotient Sciences 
Tel: +44 (0)115 974 9000 (day) 
Tel: +44 (0)7774 017236 (out of hours emergency) 
Project Manager: 
Peter Green 
Quotient Sciences 
Tel: +44 (0)115 974 9000 
Study Monitor: 
Mat Dawson 
Stoneygate Clinical Research 
260 Kimberley Road, Leicester 
LE2 1LJ, UK 
Tel: +44 (0)77 7551 1802 
 
Medical Monitor: 
Annick Janin MD 
AKJ Consulting 
659 Rue de la Combe de l’eau 01220 Divonne-les-Bains, 
France 
Tel: +33 (0) 6 29 54 71 90 
Email: janina-consultants@mmv.org   
Sponsor’s Medical 
Director/Contact: 
Dr Stephan Chalon MD PhD 
Tel: +41 79 962 9244 (Mobile) (24 h contact) 
Email: chalons@mmv.org 
 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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 08 SEP 2022 
Page 4 of 92  
 
Sponsor’s Clinical 
Lead/Contact: 
Dr Myriam El Gaaloul PhD 
Tel: +41 76 442 65 02 (Mobile) 
Email: elgaaloulm@mmv.org 
Pharmacovigilance 
Provider: 
Oliver Abschütz 
Prime Vigilance 
The Surrey Research Park, 
1 Occam Court, Occam Road, 
Guildford, Surrey, GU2 7HJ, UK 
Email: oliver.abschuetz @primevigilance.com 
Tel: +49 (0)1578 3053780 
Tel (Head Office): +44 1483 307920 
 
 
Central Laboratory: 
The Doctors Laboratory 
The Halo Building 
1 Mabledon Place 
London WC1H 9AX, UK 
Tel: + 44 (0)207 3077 404 
Bioanalytical 
Laboratory: 
Swiss BioQuant (SBQ) 
Kägenstrasse 18 
4153 Reinach, Switzerland 
Tel: +41(0) 617 1698 12 
ECG Analysis: 
Banook  
84 Avenue du Xxème Corps 
54000 Nancy, France 
+33 (0) 3 83 39 10 10  
 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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Protocol MMV_MMV367_21_01 (QSC207031) Version 3.0 
 08 SEP 2022 
Page 5 of 92  
 
1 Table of Contents 
1 
Table of Contents ............................................................................................ 5 
2 
List of Tables and Figures ............................................................................... 9 
2.1 
Table of In-Text Tables ...................................................................... 9 
2.2 
Table of In-Text Figures ..................................................................... 9 
3 
Synopsis ....................................................................................................... 10 
4 
List of Abbreviations ...................................................................................... 17 
5 
Background Information ................................................................................ 19 
5.1 
Introduction ...................................................................................... 19 
5.2 
Investigational Medicinal Product .................................................... 19 
5.3 
Previous Study Findings .................................................................. 20 
5.3.1 
Non-clinical Findings ....................................................................... 20 
5.3.2 
Clinical Findings .............................................................................. 22 
6 
Rationale ....................................................................................................... 22 
6.1 
Study Rationale ............................................................................... 22 
6.2 
Dose Rationale ................................................................................ 24 
6.3 
Population Rationale ....................................................................... 27 
6.4 
Risks and Benefits ........................................................................... 28 
6.4.1 
Risks Associated with MMV367 Administration ............................... 28 
6.4.2 
COVID-19 Related Risks and Risk Mitigation Measures .................. 28 
6.4.3 
General Risks and Overall Risk-Benefit Assessment ....................... 29 
7 
Objectives and Endpoints .............................................................................. 30 
8 
Study Design ................................................................................................. 30 
8.1 
Study Plan ....................................................................................... 30 
8.1.1 
Study Plan: Part 1 – Single Ascending Dose Cohorts ...................... 30 
8.1.2 
Study Plan: Part 2 – Food Effect Cohort .......................................... 32 
8.1.3 
Study Plan: Part 3 – Multiple Dose Cohort(s) ................................... 33 
8.2 
Criteria for In-Study Decisions ......................................................... 35 
8.2.1 
Decision Points ................................................................................ 35 
8.2.2 
Criteria for Dose Decision ................................................................ 35 
8.3 
Participant Withdrawal ..................................................................... 37 
8.4 
Participant Replacement .................................................................. 38 
8.5 
Stopping Criteria .............................................................................. 38 
8.6 
Study Termination ........................................................................... 39 
8.7 
Lost to Follow-up ............................................................................. 39 
8.8 
Treatment Assignment and Randomisation ..................................... 40 
8.8.1 
Participant Numbers ........................................................................ 40 
8.8.2 
Blinding ........................................................................................... 41 
9 
Selection of Participants ................................................................................ 42 
9.1 
Informed Consent ............................................................................ 42 
9.2 
Inclusion Criteria .............................................................................. 42 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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9.3 
Exclusion Criteria ............................................................................. 43 
9.4 
Contraception and Restrictions ........................................................ 45 
9.4.1 
Sperm Donation............................................................................... 46 
9.4.2 
Egg Donation ................................................................................... 46 
9.5 
Pregnancy ....................................................................................... 46 
9.6 
Additional Study Restrictions ........................................................... 47 
10 
Study Procedures .......................................................................................... 47 
10.1 
Screening ........................................................................................ 47 
10.1.1 
Participant Re-Screening ................................................................. 47 
10.2 
Admission and Pre-dose Procedures ............................................... 47 
10.3 
Study Day Procedures ..................................................................... 48 
10.3.1 
Blood Volume .................................................................................. 48 
10.3.2 
Timing of Procedures ...................................................................... 48 
10.3.3 
Discharge from the Clinical Unit ....................................................... 49 
10.3.4 
Return Visits .................................................................................... 49 
10.3.5 
End of Study Visits .......................................................................... 49 
10.3.6 
Medical Supervision ........................................................................ 49 
10.3.7 
Follow-up ......................................................................................... 50 
11 
Dosing of Participants ................................................................................... 50 
11.1 
Food and Fluid Intake ...................................................................... 50 
11.2 
Administration of Test Preparations ................................................. 51 
11.3 
Dosing Compliance ......................................................................... 52 
11.4 
Prior and Concomitant Medications ................................................. 52 
12 
Assessment of Efficacy ................................................................................. 52 
13 
Assessment of Pharmacokinetics, Metabolite Identification and 
Pharmacodynamics ....................................................................................... 52 
13.1 
Assessment 
of 
Pharmacokinetics 
and 
Metabolite 
Identification .................................................................................... 52 
13.1.1 
Blood Sampling for Pharmacokinetics and Metabolite 
Identification .................................................................................... 52 
13.1.2 
Urine Sampling for Pharmacokinetics and Metabolite 
Identification .................................................................................... 53 
13.2 
Assessment of Pharmacodynamics ................................................. 54 
13.3 
Taste/Palatability Evaluation ............................................................ 54 
14 
Assessment of Safety ................................................................................... 54 
14.1 
Definition and Classification of Adverse Events ............................... 54 
14.2 
Assessment of Assessment of Causality ......................................... 54 
14.3 
Recording Adverse Events .............................................................. 55 
14.4 
Serious Adverse Events .................................................................. 56 
14.4.1 
Definition of Serious Adverse Events ............................................... 56 
14.4.2 
Definition of Suspected Unexpected Serious Adverse 
Reactions ........................................................................................ 56 
14.4.3 
Expectedness (Reference Safety Information) ................................. 56 
14.5 
Laboratory Measurements ............................................................... 56 
14.5.1 
Haematology, Clinical Chemistry and Coagulation .......................... 57 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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14.5.2 
Urinalysis ......................................................................................... 57 
14.5.3 
Pregnancy Test ............................................................................... 57 
14.5.4 
Follicle-Stimulating Hormone Test ................................................... 58 
14.5.5 
Drug Screen .................................................................................... 58 
14.5.6 
Alcohol Breath Test ......................................................................... 58 
14.5.7 
Carbon Monoxide Breath Test ......................................................... 58 
14.5.8 
SARS-CoV-2 Tests .......................................................................... 58 
14.5.9 
Genetic Samples ............................................................................. 58 
14.5.10 Abnormal Laboratory Findings ......................................................... 59 
14.6 
Vital Signs Measurements ............................................................... 59 
14.7 
ECG Measurements ........................................................................ 60 
14.8 
Holter (continuous ECG) Monitoring ................................................ 60 
14.9 
Telemetry (Continuous ECG)........................................................... 61 
14.10 
Body Weight, Height and BMI .......................................................... 61 
14.11 
Physical Examination ...................................................................... 61 
14.12 
Beck Depression Inventory (BDI-II) Questionnaire ........................... 62 
14.13 
Additional Safety Procedures........................................................... 62 
15 
Statistics and Data Analysis .......................................................................... 62 
15.1 
Sample Size Justification ................................................................. 62 
15.2 
Data Management ........................................................................... 63 
15.3 
Pharmacokinetic Data Analysis ....................................................... 63 
15.4 
Metabolite Profiling and Identification Assessment .......................... 65 
15.5 
Statistical Data Analysis .................................................................. 65 
15.6 
Interim Analysis ............................................................................... 66 
16 
Safety Reporting to Regulatory Authorities and Ethics Committees............... 67 
16.1 
Events Requiring Expedited Reporting ............................................ 67 
16.2 
Urgent Safety Measures .................................................................. 67 
16.3 
Reporting ......................................................................................... 68 
16.3.1 
Reporting Serious Adverse Events .................................................. 68 
16.3.2 
Reporting of Suspected Unexpected Serious Adverse 
Reactions ........................................................................................ 68 
16.3.3 
Expedited Reporting of Events ........................................................ 68 
16.3.4 
Reporting of Urgent Safety Measures .............................................. 68 
16.3.5 
Reporting of COVID-19 Vaccine-Related Adverse Events ............... 69 
16.4 
Serious Breaches ............................................................................ 69 
17 
Protocol Amendments and Deviations ........................................................... 69 
17.1 
Amendments ................................................................................... 69 
17.2 
Protocol Deviations .......................................................................... 69 
18 
Regulatory ..................................................................................................... 69 
18.1 
Compliance ..................................................................................... 69 
18.2 
MHRA and Ethical Approval ............................................................ 70 
18.3 
Source Data .................................................................................... 70 
18.4 
Declaration of the End of the Study ................................................. 70 
18.5 
Document Storage and Archiving .................................................... 70 
18.6 
Protection of Personal Data and Confidentiality ............................... 71 
18.7 
Data Security Breach ....................................................................... 72 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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 08 SEP 2022 
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19 
Quality Control and Quality Assurance .......................................................... 72 
19.1 
Monitoring........................................................................................ 72 
20 
Finance and Insurance .................................................................................. 72 
21 
Publication .................................................................................................... 72 
22 
References .................................................................................................... 73 
Appendix 1 
Clinical Laboratory Parameters ........................................................ 75 
Appendix 2 
Schedule of Assessments: Part 1 (Cohorts 1A to 1E) ...................... 76 
Appendix 3 
Schedule of Assessments: Part 2 .................................................... 78 
Appendix 4 
Schedule of Assessments: Part 3 (Cohorts 3A to 3C) ...................... 80 
Appendix 5 
Part 1 (All Cohorts) Safety and Pharmacokinetic Assessment 
Time Points (Days 1 to 7) .............................................................................. 82 
Appendix 6 
Part 2 Safety and Pharmacokinetic Assessment Time Points 
(Days 1 to 14) ............................................................................................... 83 
Appendix 7 
Part 3 Safety and Pharmacokinetic Assessment Time Points 
(Days 1 to 9) ................................................................................................. 85 
Appendix 8 
Breakfast Content (Part 2 only) ........................................................ 87 
Appendix 9 
Example Taste/Palatability Questionnaire ....................................... 88 
Appendix 10 
Protocol Amendment Summary of Changes .................................... 90 
 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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2 List of Tables and Figures  
2.1 
Table of In-Text Tables 
Table 1 
Investigational Medicinal Product .............................................................. 19 
Table 2 
Margins between the Clinical Doses Predicted Plasma AUC(0-inf) 
and Cmax, and the Exposure at NOAEL in the Most Sensitive 
Species (Dog) ........................................................................................... 27 
Table 3 
Description of Regimens: Part 1 ............................................................... 31 
Table 4 
Description of Regimens: Part 2 ............................................................... 33 
Table 5 
Description of Regimens: Part 3 ............................................................... 34 
Table 6 
Participant Numbers ................................................................................. 41 
Table 7 
Plasma Pharmacokinetic Parameters: Part 1 and 2 .................................. 63 
Table 8 
Plasma Pharmacokinetic Parameters: Part 3 ............................................ 64 
Table 9 
Urine Pharmacokinetic Parameters: Part 1, Cohorts 1C and 1D only
 ................................................................................................................. 64 
Table 10 
QTcF Categorical Analysis ....................................................................... 66 
 
2.2 
Table of In-Text Figures 
Figure 1 
Study Sequence: Part 1 (Cohorts 1A to 1E) .............................................. 31 
Figure 2 
Study Sequence: Part 2 ............................................................................ 33 
Figure 3 
Study Sequence: Part 3 (Cohorts 3A to 3C) ............................................. 34 
 
 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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 08 SEP 2022 
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3 Synopsis 
Sponsor:  
Medicines for Malaria 
Venture 
Drug Substance: 
MMV367 
EudraCT No.: 
2022-000918-33 
Title of Study: 
A First-in-Human, Single-Centre, Single Ascending Dose, Multiple Dose and Pilot Food 
Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of MMV367 in 
Healthy Participants 
Principal Investigator: 
Nand Singh BSc, MD, DPM, MFPM 
Study Centre: 
Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, 
UK 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
To assess the safety and tolerability of single and 
multiple oral doses of MMV367 in healthy 
participants 
 
 
Incidence of adverse events (AEs), physical 
examination findings, and change from baseline 
for vital signs, electrocardiograms (ECGs) and 
laboratory safety tests. 
Secondary 
To assess the pharmacokinetics (PK) of single 
and multiple doses of MMV367 in plasma 
(Parts 1, 2 and 3) 
 
 
PK parameters such as AUC, Tmax, Cmax, CL/F, 
Vz/F, T1/2 and AR, when applicable 
To assess the effect of a high-fat meal on the PK 
of a single dose of MMV367 in healthy 
participants (Part 2 only) 
 
PK parameters such as AUC, Tmax, Cmax and 
Frel, as appropriate, under fed and fasted 
conditions 
Exploratory  
To assess the PK of single dose of MMV367 in 
urine (Part 1 only) of healthy participants 
(optional)a 
 
 
Urine PK parameters such as Ae, and derived 
plasma PK parameters such as CLr, when 
applicable 
To assess exposure response relationship for 
potential effects of MMV367 on ECG intervals 
(QT, QTcF, QTcB, PR, QRS)b 
 
 
ECG intervals, MMV367 plasma concentrations 
(time-matched) 
To investigate metabolite(s) of MMV367 in healthy 
participantsa 
 
Metabolite characterisation for MMV367 in 
plasma and urine, when applicable 
To evaluate the taste attributes (smell, sweetness, 
bitterness, flavour, mouthfeel/texture, grittiness 
and aftertaste) and overall acceptability of the IMP 
(Part 1 only) 
Taste questionnaire score, based on a 9-point 
Likert scale assessing the acceptability for each 
taste attribute (smell, sweetness, bitterness, 
flavour, mouthfeel/texture, grittiness, and 
aftertaste) and overall acceptability for each dose 
level of MMV367 
a Depending on availability of the data, these objectives may be reported in an addendum to the final study 
Clinical Study Report (CSR) or in a separate report. 
b This objective will be reported in a separate cardiac safety report and will not be part of the final study CSR 
Number: DOC-87929               Version: 3.0               Status: Approved    Approved Date: 09 Sep 2022
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 08 SEP 2022 
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Methodology: 
Part 1: Single Ascending Dose Cohorts 
Part 1 will be a double-blinded, randomised, placebo-controlled, single ascending dose 
(SAD) study, which will comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E 
will be optional), with 8 participants in each cohort. Participants will be randomly 
assigned to receive a single oral dose of either active IMP (6 participants) or placebo 
(2 participants) to assess its safety, tolerability and PK profile. Each participant will take 
part in one cohort and will receive one of the following regimens according to the 
randomisation schedule: 
SAD Cohort 
Regimen 
IMP 
Dose 
Route of 
Administration 
1A 
1 
MMV367 or 
placebo 
100 mg 
Oral, Fasted 
1B 
2 
MMV367 or 
placebo 
300 mga 
Oral, Fasted 
1C 
3 
MMV367 or 
placebo 
750 mga 
Oral, Fasted 
1D 
4 
MMV367 or 
placebo 
1500 mga 
Oral, Fasted 
1E 
Optional 
5 
MMV367 or 
placebo 
2000 mga 
Oral, Fasted 
a Predicted dose. There will be a blinded interim review of the safety, tolerability and PK data after each 
cohort prior to the dose decision for subsequent cohorts.  
The data obtained from each cohort (safety and PK) will undergo a formal review by the 
safety advisory committee (SAC). The SAC will determine if it is safe to proceed with the 
next dose/cohort. Following review of the emerging PK data from each preceding cohort, 
if results suggest that the exposure plateau has been reached, the next planned cohort 
will not be conducted. Similarly, if PK predictions suggest that this exposure plateau 
would be exceeded at the next cohort/dose level, a lower dose than originally anticipated 
will be proposed. 
Part 2: Food Effect Cohort 
Part 2 will be an open-label, randomised, balanced two-period crossover, food effect 
evaluation. The effect of food on the PK of MMV367 will be explored in Part 2 by 
administering a single dose of MMV367 after a high-fat breakfast, as per FDA guidance 
(Appendix 8), and a single dose of MMV367 in the fasted state.  
Each participant will receive 2 single doses of MMV367. In Period 1, participants will be 
randomised 
to 
1 
of 
2 
treatment 
sequences 
(Regimen 
6/Regimen 
7 
or 
Regimen 7/Regimen 6). If a participant is randomised to receive MMV367 in the fasted 
state (Regimen 6) in Period 1, they will receive MMV367 in the fed state (Regimen 7) in 
Period 2 and vice versa. 
The following regimens will be administered according to the randomisation schedule: 
Food Effect 
Cohort 
Period 
Regimen 
IMP 
Dosea 
Route of 
Administration 
2A 
1 and 2 
(randomised) 
6 
MMV367 
XX mg 
Oral, Fasted 
7 
MMV367 
XX mg 
Oral, Fed 
a The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of 
MMV367 and a safe exposure window has been established in Part 1. The dose for Regimens 6 and 7 will 
be the same. 
Part 3: Multiple Dose Cohort(s) 
Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A 
total of 8 participants per cohort will receive once-daily doses of MMV367 (6 participants) 
or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability 
and PK profile of multiple dosing. 
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The following regimen(s) will be administered according to the randomisation schedule: 
Multiple Dose 
Cohort 
Regimen 
IMP 
Dosea 
Route of 
Administration 
3A 
8 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
3B 
Optional 
9 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
3C 
Optional 
10 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
a The dose(s) administered in Part 3 will be determined after review of the data from Part 1. 
Parts 2 and 3 may be conducted before completion of Part 1 provided that this is justified 
by PK and safety data obtained from completed cohorts in Part 1. The total amount of 
active IMP administered as multiple doses in Part 3 will be no greater than the maximum 
safe and well tolerated dose in Part 1, dosed at a single dose level. Parts 2 and 3 may 
be conducted in parallel. 
The data obtained (safety and PK) from the multiple dose administration will undergo a 
formal review by the SAC after all 8 participants have completed the study. 
Consequently, Part 3 may be extended to evaluate a second and/or third dose level in a 
3-day once daily regimen. 
Study Design: 
The study is divided into Parts 1, 2 and 3. For each of the three parts, participants will be 
screened within 28 days prior to first admission to the clinical unit on the morning of 
Day -1.  
Part 1: Single Ascending Dose Cohorts 
In each cohort, participants will be dosed on Day 1 and will remain resident in the clinical 
unit until discharge on Day 5. They will attend the clinical unit for a return visit on Day 7 
and again on Day 15 (± 1 day) for end of study assessments. Blood samples will be 
collected at regular intervals for PK analysis and safety from Day 1 to discharge from the 
study on Day 15 (± 1 day). Each cohort will follow the same study design. 
Participants will also complete a written taste/palatability questionnaire individually and 
privately following administration of the IMP. 
Part 2: Food Effect Cohort 
Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and 
will remain resident in the clinical unit until discharge on Day 12. They will attend the 
clinical unit on Day 14 (± 1 day) for end of study assessments. Based on emerging PK 
data from Part 1, the washout period between the Period 1 and Period 2 doses may be 
extended. Blood samples will be collected at regular intervals for PK analysis and safety 
from Day 1 to discharge from the study on Day 14 (± 1 day). 
Part 3: Multiple Dose Cohort(s) 
Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the 
clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on 
Day 9 and again on Day 17 (± 1 day) for end of study assessments. Blood samples will 
be collected at regular intervals for PK analysis and safety from Day 1 to discharge from 
the study on Day 17 (± 1 day). Each cohort will follow the same study design. 
Parts 1 and 3 will follow a sentinel dosing design. On the first day of dosing in each cohort 
in Part 1 and in Part 3, only 2 (sentinel) participants will be dosed. The randomisation 
schedule will be constructed such that 1 of the participants dosed on the first day will 
receive MMV367 and 1 will receive placebo. After review of the safety data up to 96 h 
post-dose for SAD cohorts in Part 1 and up to 96 h post-final dose in Part 3, the 
investigator, or medically qualified designee who is familiar with the study protocol and 
Investigator’s Brochure, and medical monitor or delegate (with approval from the 
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sponsor’s medical director or delegate) will decide whether to proceed with dosing the 
remaining participants in the cohort. 
Number of Participants Planned: 
In Part 1, it is planned to enrol 8 healthy male and female participants per cohort to 
ensure data in a minimum of 4 participants (per cohort) on active investigational 
medicinal product (IMP). 
In Part 2, it is planned to enrol 8 healthy male and female participants to ensure data in 
a minimum of 6 participants. 
In Part 3, it is planned to enrol 8 healthy male and female participants per cohort (if 
optional cohorts are utilised) to ensure data in a minimum of 4 participants (per cohort) 
on active IMP. 
Participants withdrawn due to an IMP-related adverse event (AE) will not be replaced. 
Participants who are withdrawn for other reasons may be replaced as required by 
agreement between the investigator and the sponsor to ensure sufficient evaluable 
participants.  
In Part 1, up to 2 replacement participants may be used per cohort. The maximum 
number of participants that may be dosed is 50 (8+2 per cohort). 
In Part 2, up to 4 replacement participants may be enrolled into the study. The maximum 
number of participants that may be dosed in Part 2 is 12 (8+4). 
In Part 3, up to 2 replacement participants per cohort (if optional cohorts are utilised) may 
be enrolled into the study. The maximum number of participants that may be dosed is 
30 (8+2 per cohort). 
Duration of Study: 
The estimated time from screening until the end of study visit is approximately 6 weeks 
for Parts 1, 2 and 3. 
Main Inclusion Criteria: 
Healthy males and healthy females aged 18 to 55 years inclusive at the time of signing 
informed consent. 
Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening. 
Investigational Medicinal Product, Dose and Mode of Administration: 
The following IMP will be used in this clinical study. 
IMP Name 
Dose  
Route of Administration 
MMV367 Dispersible Granules, 
250 mg/g (25% w/w) 
Starting dose 100 mga 
Oral, Fasted (Parts 1, 2 and 
3) or Oral, Fed (Part 2) 
Placebo for MMV367 Dispersible 
Granules, 250 mg/g (25% w/w) 
N/A 
Oral, Fasted (Parts 1 and 3) 
a Doses are not predicted to exceed the AUCcap set at 376 µg.h/mL, which is based on linear PK projections 
for a putative dose of 2000 mg or Cmaxcap set at 23.8 µg/mL, which is based on mean Cmax at the NOAEL 
in dog 
The IMP will be dispersed in sterile water. Immediately after administration of the oral 
solution, the dosing vessel will be rinsed with water and participants will consume the 
rinse solution. During dosing, participants will consume up to a maximum total volume of 
500 mL (including the dosing volume and volume of water used to rinse the dosing 
vessel) depending on the dose level. If required, additional water in 50 mL aliquots may 
be given with the test product. 
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Pharmacokinetic Assessments: 
Blood samples for PK analysis will be collected at regular time intervals. The plasma 
concentration-time data for MMV367 will be analysed by Quotient Sciences using 
industry standard software (WinNonlin v8.3 or a more recent version, Certara USA, Inc., 
USA) and appropriate non-compartmental techniques to obtain estimates of the following 
parameters, where possible and appropriate: 
Plasma Pharmacokinetic Parameters: Part 1 and 2 
Parameter 
Definition 
Tmax 
Time of maximum observed concentration 
Cmax 
Maximum observed concentration 
AUC(0-24) 
Area under the curve from time 0 to 24 h post-dose 
AUC(0-48) 
Area under the curve from time 0 to 48 h post-dose 
AUC(0-last) 
Area under the curve from time 0 to the time of last measurable concentration 
AUC(0-inf) 
Area under the curve from time 0 extrapolated to infinity 
T1/2  
Terminal elimination half-life 
CL/F 
Total body clearance calculated after a single extravascular administration where 
F (fraction of dose bioavailable) is unknown 
Vz/F 
Apparent volume of distribution based on the terminal phase calculated using 
AUC(0-inf) after a single extravascular administration where F (fraction of dose 
bioavailable) is unknown 
Frel Cmax 
Relative bioavailability based on Cmax (Part 2 fed dosing only) 
Frel AUC(0-last) 
Relative bioavailability based on AUC(0-last) (Part 2 fed dosing only) 
Frel AUC(0-inf) 
Relative bioavailability based on AUC(0-inf) (Part 2 fed dosing only) 
Plasma Pharmacokinetic Parameters: Part 3 
Parameter 
Definition 
Tmax 
Time of maximum observed concentration 
Cmax 
Maximum observed concentration 
AUC(0-tau) 
Area under the curve for the defined interval between doses (tau) 
T1/2  
Terminal elimination half-life (Day 3 only) 
CL/Ftau 
Total body clearance calculated using AUC(0-tau) after repeated extravascular 
administration where F (fraction of dose bioavailable) is unknown (Day 3 only) 
Vz/Ftau 
Apparent volume of distribution based on the terminal phase calculated using 
AUC(0-tau) after repeated extravascular administration where F (fraction of dose 
bioavailable) is unknown (Day 3 only) 
AR Cmax 
Accumulation ratio based on Cmax repeated dose/Cmax single dose (Day 3 only) 
AR AUC 
Accumulation ratio based on AUC(0-tau) repeated dose/AUC(0-tau) single dose 
(Day 3 only)  
Analysis of drug related QT/QTc interval changes relative to plasma PK concentrations 
will be conducted. This analysis will be performed on the analysis set for intensive cardiac 
assessment. Concentration/QTc modelling may be performed after completion of the 
CSR and will be reported separately. 
In Part 1 Cohorts 1C and 1D, urine samples will be collected at regular time intervals 
provided a future bioanalytical method is available. Urine concentration data for MMV367 
will be analysed by Quotient Sciences and reported in an addendum to the CSR or in a 
separate report. Estimates of the parameters of the following parameters in urine will be 
obtained where possible and appropriate: 
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Urine Pharmacokinetic Parameters: Part 1, Cohorts 1C and 1D only 
Parameter 
Definition 
CLr 
Renal clearance calculated using plasma AUC 
Ae 
Amount excreted 
CumAe 
Cumulative amount excreted 
%Ae 
Percentage of dose excreted 
Cum%Ae 
Cumulative percentage of dose excreted  
Metabolite Profiling and Identification Assessment:  
Metabolite profiling of MMV367 in plasma and urine will be performed using existing PK 
samples (pooled residual samples) collected in Part 1. Potential metabolites will be 
identified using liquid chromatography-mass spectrometry analysis. If results suggest 
that a major metabolite is present in plasma (e.g. greater than 10% of circulating 
MMV367 in plasma based on peak AUCs), metabolite quantification and PK analysis in 
plasma will be performed provided a future bioanalytical method is available. These 
results may be reported in an addendum to the CSR or in a separate report. 
Taste/Palatability Questionnaire  
Taste/palatability will be assessed in Part 1 using a questionnaire. The questionnaire will 
ask participants to rate the overall acceptability of palatability, with additional questions 
asked on specific palatability attributes (smell, sweetness, bitterness, flavour, mouth 
feel/texture, grittiness and aftertaste). 
Safety Assessments: 
The safety assessments to be conducted are: 
• 
AE monitoring 
• 
12-lead ECGs 
• 
Holter ECG monitoring 
• 
Telemetry 
• 
Vital signs 
• 
Clinical laboratory tests (clinical chemistry, haematology, coagulation and urinalysis) 
• 
Physical examinations 
Statistical Methodology: 
Assessment of Dose Proportionality  
For Part 1, dose proportionality will be assessed using a power model approach using 
log-transformed Cmax, AUC(0-last) and AUC(0-inf) values, including data from up to 
5 different dose levels, i.e. general linear model including log dose as a fixed effect and 
log PK parameter as the dependent variable. The estimate obtained for β together with 
its 90% confidence interval (CI) will be presented along with the number of participants 
and the geometric means. The resulting estimate slope (β) and 90% CI is a measure of 
dose proportionality; the relationship is considered dose proportional when β = 1. 
Assessment of Taste Questionnaire Data  
In Part 1, formal statistical analysis will be performed on the scores of each taste attribute 
and overall acceptability, in the comparison of each dose level of MMV367 to the pooled 
placebos, using non-parametric methods. Hodges-Lehmann estimation methods will be 
used to estimate the median difference between each dose level and the pooled 
placebos. The associated 95% CI will be calculated for the estimate. The p-value will be 
calculated from the Wilcoxon Rank Sum Test (Mann-Whitney-Wilcoxon Test) for the test 
of the null hypothesis that the difference between the medians of each dose level and 
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the pooled placebos is equal to zero, with the alternative hypothesis being that the 
difference is not equal to zero.  
The number of participants and the median score for each treatment will be presented 
together with the Hodges-Lehmann estimate of the median difference and associated 
90% CI. In addition, the p-value from the Wilcoxon Rank Sum Test will also be presented. 
Assessment of Food Effect 
In addition, for Part 2, formal statistical analysis will be performed, at a minimum, on the 
following PK parameters: Cmax, AUC(0-last) and AUC(0-inf) to assess for the effects of 
food. The PK parameters will undergo a natural logarithmic transformation and will be 
analysed using a mixed effect model with terms for fed/fasted status and period fitted as 
fixed effects and participant fitted as a random effect. The adjusted mean difference 
between the fed and fasted states, and the associated 90% CI obtained from the model 
are back transformed on the log scale to obtain the adjusted geometric mean ratio and 
90% CI of the ratio. These will be presented together with the p-value from the fed/fasted 
comparison.  
Sample Size and Power: 
For Parts 1 and 3, the primary objective is an initial assessment of safety and each 
treatment group is therefore limited to 6 participants receiving active IMP. Administration 
of MMV367 to 6 participants at each dose level provides a 47%, 62%, 74%, or 82% 
probability of observing at least 1 occurrence of any AE, with a true incidence rate for a 
given dose group of 10%, 15%, 20%, or 25%, respectively. 
Furthermore, it is assumed that pooling the data for the 2 participants who receive 
placebo in each cohort will provide an adequately sized control group to assess a 
possible drug effect on safety laboratory tests, vitals and ECG parameters. 
Part 2 is a pilot evaluation designed to determine whether MMV367 PK is impacted by 
high-fat food. Historically, 8 participants have proven sufficient to characterise the 
preliminary effects of food on safety and PK of a new chemical entity in healthy 
participants. Therefore, a sample size of 8 is considered adequate at this stage of drug 
development. 
In Parts 1 and 3, a participant will be considered evaluable if they have received study 
drug and completed safety and PK assessments up to 96 h post-dose (Part 1)/post-final 
dose (Part 3). In Part 2, a participant will be considered evaluable if they have received 
study drug and completed safety and PK assessments up to 96 h post-dose in both 
periods. 
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4 List of Abbreviations 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
BDI-II 
Beck Depression Inventory 
BMI 
body mass index 
CI 
confidence interval 
CLcr 
creatinine clearance 
COVID-19 
Coronavirus Disease 2019 
CSPM 
Clinical Sample Processing Manual 
CV% 
coefficient of variation 
CYP 
cytochrome P450 
DBP 
diastolic blood pressure 
DMP 
data management plan 
EC 
ethics committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form  
FIH 
first-in-human 
FSH 
follicle stimulating hormone 
GCP 
good clinical practice 
GLP 
good laboratory practice 
HBsAg 
hepatitis B surface antigen 
HCV Ab 
hepatitis C virus antibody 
HED 
human equivalent dose 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IMP 
investigational medicinal product 
ISF 
Investigator Site File 
MHRA 
Medicines and Healthcare products Regulatory Agency 
NOAEL 
No-Observed-Adverse-Effect Level 
PBPK 
physiological-based pharmacokinetic 
PIS 
Participant Information Sheet 
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PK 
pharmacokinetic(s) 
QA 
quality assurance 
QD 
once daily 
QTcB 
Corrected QT interval by Bazett’s formula 
QTcF 
Corrected QT interval by Fridericia’s formula 
RAP 
Reporting and Analysis Plan 
SAC 
safety advisory committee 
SAD 
single ascending dose 
SAE 
serious adverse event 
SAR 
serious adverse reaction 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SBP 
systolic blood pressure 
SoC 
standard of care 
SOP 
standard operating procedure 
SUSAR 
suspected unexpected serious adverse reaction 
WOCBP 
woman of childbearing potential 
 
The pharmacokinetic definitions used in this study are presented in Section 15.3. 
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5 Background Information 
5.1 
Introduction  
MMV367 is a first in class, fast acting, orally bioavailable blood stage inhibitor of 
Plasmodium falciparum. It is highly active against different Plasmodium falciparum 
mutants and field panels exhibiting various resistance profiles, thus demonstrating 
absence of cross resistance to other antimalarial drugs. MMV367 is being developed 
primarily for the curative treatment of acute uncomplicated malaria, due to Plasmodium 
falciparum in adults and children, as a single dose regimen (best case) or up to a 3-day 
treatment, in a fixed-dose combination with another active and safe non-artemisinin 
antimalarial drug. 
Malaria is a major infectious disease caused by Plasmodium parasites and transmitted 
by infected female Anopheles mosquitoes. Despite the fact that five different species can 
cause malaria in humans (falciparum, vivax, malariae, ovale and knowlesi), Plasmodium 
falciparum is by far the deadliest species and is responsible for the high mortality. In 
2020, there were an estimated 241 million cases of malaria, an increase of approximately 
14 million cases compared to 2019. Deaths reached 627000 compared to 558000 in the 
previous year. Most of the deaths occurred in the African region (94%) [1]. 
Historically, antimalarials have been designed to kill the intraerythrocytic stages of the 
parasite lifecycle that are directly responsible for the symptoms of the disease. Based on 
a high-throughput whole cell phenotypic screen, a new pyrrolidinamide class of 
antimalarials was selected for further research [2]. Within this novel antimalarial 
pyrrolidinamide series, MMV367 was identified as the most balanced compound; it is a 
compound able to kill parasite asexual blood stages.  
None of the current clinical antimalarials share a similar mode of action and/or 
mechanism of resistance. It is anticipated that MMV367 exerts a novel antimalarial 
mechanism. 
The clinical development programme will aim to evaluate the safety and efficacy of 
MMV367 in the treatment of acute uncomplicated malaria in adults and children. In this 
first-in-human (FIH) study, the safety, tolerability and pharmacokinetics (PK) of MMV367 
will be assessed in healthy adult participants. 
5.2 
Investigational Medicinal Product 
The investigational medicinal product (IMP) that will be used in this clinical study is 
presented in Table 1. 
Table 1 
Investigational Medicinal Product 
IMP Name 
Dose 
Route of Administration 
MMV367 Dispersible Granules, 
250 mg/g (25% w/w) 
Starting dose 100 mga 
Oral, Fasted (Parts 1, 2 and 
3) or Oral, Fed (Part 2) 
Placebo for MMV367 Dispersible 
Granules, 250 mg/g (25% w/w) 
N/A 
Oral, Fasted (Parts 1 and 3) 
a Doses are not predicted to exceed the AUCcap set at 376 µg.h/mL, which is based on linear PK projections 
for a putative dose of 2000 mg or Cmaxcap set at 23.8 µg/mL, which is based on mean Cmax at the NOAEL 
in dog 
The IMP is an un-licensed medicinal product for use only in the proposed clinical trial.  
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Only participants enrolled in the study may receive study treatment and only authorised 
site staff may supply or administer study treatment. All study treatments will be stored in 
a secure, environmentally-controlled, and monitored (manual or automated) area in 
accordance with the labelled storage conditions with access limited to the investigator 
and authorised site staff. 
Where Quotient Sciences (hereafter referred to as Quotient) is manufacturing the IMP(s), 
suitability of the manufacturing process will be documented in a Pharmaceutical 
Development and Control Strategy Report. 
IMPs will be reconciled and destroyed in accordance with the study-specific quality 
agreement and technical addendum. 
5.3 
Previous Study Findings 
Full details of previous non-clinical study findings can be found in the Investigator’s 
Brochure (IB) [3]. A summary of the non-clinical findings is provided below. No clinical 
studies have been conducted with MMV367. 
5.3.1 Non-clinical Findings 
5.3.1.1 Primary Pharmacology 
MMV367 exhibited potent in vitro activity against asexual stages of both sensitive and 
multi-drug resistant Plasmodium falciparum strains including fresh clinical isolates. 
Furthermore, MMV367 was active against other Plasmodium species (knowlesi and 
vivax) although with reduced potency compared to falciparum. The in vitro and in vivo 
parasite killing rates were high and comparable to artemisinins. The in vitro frequency of 
spontaneous resistance measured for MMV367 was low. In vivo, the compound 
demonstrated good oral efficacy in a Plasmodium falciparum murine model, with a 
potency comparable to or greater than marketed antimalarial drugs. 
Preliminary target identification efforts conducted in order to characterise the mode of 
action of MMV367 suggest the involvement of the acyl CoA synthetase (ACS) pathway. 
This putative new mode of action could offer differentiation against all other antimalarials 
in clinical use or currently in development, which is of paramount importance in the 
development of de novo combination treatments, thereby ultimately avoiding the 
emergence of resistance. Model simulations predicted that a single human dose of 
440 mg of MMV367 can potentially decrease 12 logs parasitaemia burden in acute 
uncomplicated malaria, generally parasite burden in acute uncomplicated malaria is 
lower than 12 logs and, therefore, predicted reduction by 12 logs indicates robust and 
potent antimalarial activity. The same efficacy can potentially be obtained with a dose of 
100 mg once daily (QD) for two consecutive days or 30 mg QD for three consecutive 
days. 
Results from activity measurements of MMV367 against parasite sexual stages 
suggested that MMV367 inhibits parasite development in the mosquito, but without 
affecting the functionality of mature gametocytes, thereby indicating lack of activity of 
MMV367 against mature gametocytes. 
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Activity against Plasmodium falciparum liver stages 
The potential of MMV367 to inhibit intrahepatocytic parasite development was assessed 
in an infected primary human hepatocyte assay. Salivary gland sporozoites, isolated 
from mosquitoes infected with NF175 Plasmodium falciparum were used to infect 
cultured human hepatocytes. The percentage of infected hepatocytes was determined 
by immunofluorescence staining and automated high content imaging. MMV367 was 
tested in nine dilutions; 10 μM to 1 nM or 1 μM to 0.1 nM. MMV367 was found to inhibit 
liver stage parasites at relatively low concentrations (half maximal inhibitory 
concentration = 1.7 to 29.3 nM). 
5.3.1.2 Pharmacokinetics 
High oral bioavailability was observed in rats, and moderate oral bioavailability for mice 
and dogs. Minipigs showed a low bioavailability. Based on a physiological-based 
pharmacokinetic (PBPK) model, it has been predicted that MMV367 shows a high oral 
bioavailability, moderate volume of distribution and low blood clearance in humans, with 
a predicted human half-life of 19 h. Results from in vitro studies with human hepatocytes 
suggested that MMV367 is metabolised slowly in humans (predicted liver elimination of 
1.60 mL/min/Kg). MMV367 has a low potential for drug-drug interactions based on in 
vitro findings. Results from a PK study in dogs suggested that concomitant food intake 
may increase systemic exposure to MMV367. Toxicokinetic data indicated that at high 
doses, elimination of MMV367 is limited by the solubility resulting in a prolonged 
apparent half-life. 
Following intravenous administration of MMV367 to mice, rats dogs and minipigs, 
clearance values were low in mice and rats but high for dogs and minipigs. Associated 
mean terminal half-lives ranged between 0.6 h (dogs) and 2.1 h (mice). 
5.3.1.3 Safety Pharmacology and Toxicology 
In line with ICH M3 (R2) [11] and a previous FIH conducted with another malaria drug 
candidate in the US [4], standard safety pharmacology studies and 7-day oral toxicity 
studies in rats and dogs were conducted to support a short treatment course from single 
dose to 3 days against acute uncomplicated malaria. These studies demonstrated that 
MMV367 has a low oral toxicity. In rats, 100, 300 and 1000 mg/kg/day doses were 
administered. In male rats, 300 mg/kg/day was well tolerated and was the No-Observed-
Adverse-Effect-Level (NOAEL); the NOAEL was 100 mg/kg/day in female rats. In dogs, 
100, 300 and 1000 mg/kg/day doses were administered, and the NOAEL was assessed 
at 300 mg/kg/day in males and females.  
Microscopic findings in the adrenal glands (cortical hypertrophy with vacuolation) and 
thymus (atrophy) have been observed in the 7-day toxicology study in rats. Overall, these 
observations, which were not detected in dogs, are compatible with a transient and 
reversible stress-induced cortical hypertrophy and changes in lipid composition. While 
no signal for the human targets interfering with lipid metabolism were observed with 
MMV367, positive staining for adipophilin and negative staining for LAMP-2 were 
observed in the rat adrenal glands, suggesting the vacuoles were likely to be neutral fat, 
which is supportive of a transient and reversible effect. 
MMV367 was not mutagenic in the Ames test, showed no clastogenic potential in the in 
vivo rat model and no DNA damage potential in the in vivo Comet test. Standard 
reproductive toxicity studies have not been conducted. In an in vitro study using the rat 
whole embryo culture assay, MMV367 showed no teratogenic potential. 
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The effect of MMV367 on central nervous system function was assessed in rats in a 
GLP-study. Rats (N=6/group) were given single oral doses (gavage) of MMV367 at 0 
(vehicle control), 100, 300 and 1000 mg/kg. MMV367 did not induce signs of CNS toxicity 
in the primary observation test over a 24-h recording period. 
The effect of MMV367 on cardiovascular function was assessed in a GLP-study of 
beagle dogs. Each dog received single oral administrations (gavage) of 0 (vehicle), 100, 
300 and 1000 mg/kg of MMV367 in a randomised crossover fashion. The washout period 
between treatments was at least 48 h. Telemetry recordings lasted for 24 h after each 
administration. 
MMV367 caused a slight and transient increase in arterial blood pressure at 1000 mg/kg. 
The effect reached its maximum at 2 h post-dose (125 ± 2 mmHg for mean arterial blood 
pressure vs. 108 ± 5 mm Hg with vehicle, i.e. +16% from controls, p <0.01). At 
1000 mg/kg MMV367, a slight but prolonged increased mean heart rate was observed. 
The effect was observed from 2 to 20 h post-dose but reached statistical significance at 
12 h (94 ± 3 vs. 69 ± 5 bpm with vehicle, i.e. +36% from controls, p <0.01). Lower doses 
had no effect on arterial blood pressure or heart rate. 
Irrespective of the dose level, MMV367 had no statistically significant effects on core 
temperature, QT and QTc intervals, no substantial effects on the QA interval, pulse 
pressure, and rate pressure product, and no effects on the PR and the QRS interval 
duration. No arrhythmia or other changes in the morphology of the electrocardiograms 
(ECGs) that could be attributed to MMV367 were observed over the test period in any of 
the dogs. 
The effect of MMV367 on respiratory function was evaluated in rats in a GLP-study. The 
rats received single oral administrations (gavage) of 0 (vehicle), 100, 300 and 
1000 mg/kg of MMV367. Measurements took place over 24 h following administration of 
MMV367 or vehicle. At the highest dose (1000 mg/kg), MMV367 decreased peak 
inspiratory (-48%) and expiratory flows (-48%), tidal volume (-36%) and minute volume 
(-40% at 12 h and -60% at 24 h) from 6 h post-dose. The effects reached statistical 
significance at 12 and 24 h for minute volume and at 24 h for the other parameters. Lower 
doses had no substantial effects effect on respiratory function over the 24-hour test 
period. 
5.3.2 Clinical Findings 
MMV367 has not been administered to humans previously. This study will be the first 
time MMV367 will be administered in humans (FIH). 
6 Rationale 
6.1 
Study Rationale 
The main purpose of this FIH study with MMV367 is to generate safety, tolerability and 
PK data when MMV367 is first administered to healthy men and women as escalating 
single ascending doses (Part 1) under fasted conditions. In addition, the potential effect 
of food consumption (high-fat meal) on the PK and safety at the selected dose level will 
be assessed (Part 2) and 3-day multiple doses (Part 3) will be investigated.  
The rationale for taking MMV367 into further development is the expectation that this 
compound could be effective for the treatment of acute uncomplicated Plasmodium 
falciparum malaria with a therapeutic regimen that would ideally be given in a fixed dose 
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combination as a single dose regimen (single dose-single cure treatment) but could also 
be used in a standard fixed dose combination regimen of up to 3 days treatment (QD 
administration). Prior to initial testing in malaria patients, the safety and the PK 
characteristics of the drug in healthy participants must be investigated in order to provide 
sufficient data to proceed with the proof-of-concept study in the patient population. 
Preliminary information regarding the impact of food will also support further 
recommendations for the clinical development programme. 
Parts 1 and 3 of this study will be placebo-controlled to establish the frequency and 
magnitude of changes in safety endpoints that may occur in the absence of active 
treatment. As Part 2 of this study will administer single doses of a single formulation in a 
crossover design to evaluate food effect, Part 2 will be open-label. 
Randomisation will be used in all three study parts to minimise bias in the assignment of 
participants to treatment groups, to increase the likelihood that known and unknown 
participant attributes (e.g. demographic and baseline characteristics) are evenly 
balanced across treatment groups, and to enhance the validity of comparisons across 
dose groups. Blinded treatment will be used in Parts 1 and 3 to reduce potential bias 
during data collection and evaluation of clinical endpoints. 
In Parts 1 and 3, to protect the safety of participants enrolled, a sentinel dosing design 
will be followed for all cohorts: 1 participant will receive active IMP and 1 participant will 
receive matching placebo initially. The remaining 6 participants (5 active, 1 placebo) will 
be dosed approximately 96 h post-dose (Part 1)/post-final dose (Part 3); the decision to 
dose the remaining participants will be made based on the available safety data. After 
review of the safety data up to 96 h post-dose (Part 1)/post-final dose (Part 3), the 
investigator, or medically qualified designees who are familiar with the study protocol 
and IB, and medical monitor or delegate (with approval from the sponsor’s medical 
director or delegate) will decide whether to proceed with dosing the remaining 
participants in the cohort (main group). 
All approved standard of care treatments for acute uncomplicated malaria are 
administered for a maximum of 3 days duration. Therefore, in this study, MMV367 will 
be administered QD (morning dose) for a maximum of 3 days in Part 3. Considering its 
anticipated half-life of approximately 19 h, steady-state concentrations will not be 
achieved with a 3-day regimen. Although the pharmacological profile and PK properties 
of MMV367 are both expected to provide a single dose cure for acute uncomplicated 
malaria, the evaluation of a 3-day regimen will allow the assessment of tolerability and 
safety for an alternative therapeutic strategy in the target population. The assessment of 
up to a 3-day treatment regimen may be useful if a disconnect is observed in the 
predicted efficacy of the malaria human challenge model or malaria patients, such that 
MMV367 needs to be administered over 2 or 3 days to ensure a cure. Additionally, 
MMV367 will ultimately be administered/deployed in a fixed dose-combination regimen 
with an existing or novel antimalarial drug and dosing frequency will have to take the 
pharmacology of any proposed partner drug into account. 
This study may also identify the genetic factors that affect the PK of MMV367 in humans 
through exploratory pharmacogenetic sampling. Such analysis will be triggered after 
study completion if specific safety and/or PK observations suggest that a genetic 
polymorphism could potentially account for variability in the study. 
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6.2 
Dose Rationale 
The recommendations of the following guidelines have been considered when setting 
the starting dose and escalation rules for this trial:  
• 
Guideline on strategies to identify and mitigate risks for first-in-human and early 
clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07 
Rev. 1), 20 July 2017 [5]  
• 
Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical 
Trials for Therapeutics in Adult Healthy Volunteers. U.S. Department of Health and 
Human Services Food and Drug Administration Center for Drug Evaluation and 
Research. July 2005 [6] 
Part 1 
The maximum recommended safe starting dose (MRSD) of 100 mg was calculated 
based on results from two GLP toxicology studies in rats (male/females) and dogs 
(male/females) supporting Phase I and in accordance with the 2005 FDA [6] and the 
2017 [5] EMEA Guidances. The female rat was identified as the most sensitive species 
to set the starting dose according to the 2005 FDA guidance, whereas the dog was 
identified to be the most sensitive species with regards to the drug exposure, i.e. lower 
exposure at NOAEL, and was therefore selected to set the highest achievable human 
exposure. 
To set the starting dose, the NOAEL of the most sensitive species was selected from the 
7-day rat GLP toxicology study (NOAEL observed in female rats) and was 
100 mg/kg/day. On the basis of body surface area, the corresponding extrapolated 
human equivalent dose (HED) for a human body weight of 60 kg was 960 mg. Applying 
a safety factor of 10, a starting dose of 100 mg can be supported from a toxicology 
perspective. This proposed starting dose is approximately 4 times below the predicted 
human efficacious single dose (440 mg) for treatment of acute uncomplicated malaria 
and is expected to be devoid of pharmacological activity in healthy participants. 
Based on human PK predictions and assuming human bioavailability of approximately 
90%, the proposed starting dose of 100 mg is associated with a safety margin of 
approximately 60-fold for AUC (i.e. compared with cumulative AUC(0-168) at the dog 
NOAEL) and 30-fold for Cmax. 
Part 2 
Since MMV367 is a lipophilic molecule and considering the median bioavailability range 
of 13% to 94% in pre-clinical species, there is potential for increase in its bioavailability 
in the presence of high-fat food. In addition, a PK study in dogs showed that food 
consumption increases MMV367 exposure. The maximum exposure for a dose of 
400 mg when administered with food (assuming close to 100% bioavailability) is 
expected to be less than a 750 mg single dose administered fasted considering predicted 
human bioavailability; therefore, Part 2 is planned to run after completion of safety and 
PK analysis of Cohort 1C data, in which a 750 mg dose is predicted for administration.  
Part 3 
The final selection of multiple doses to be administered in Part 3 will be confirmed based 
on preliminary PK results and safety data from the single ascending dose (SAD) cohorts 
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(Part 1). The predicted exposure (AUC(0-inf)) of the cumulative dose after a 3-day 
treatment will not exceed that of a single dose evaluated in Part 1. It is proposed to 
administer a cumulative dose of 600 mg to participants in Part 3 (200 mg every 24 h for 
3 days), but this will be confirmed on review of data from Part 1. 
Estimated Human Minimal Efficacious Dose 
Pre-clinical studies using a validated pre-clinical model for malaria (SCID mice inoculated 
with Plasmodium falciparum-infected red blood cells) were used to establish the minimal 
parasiticidal concentration (MPC) and the minimal inhibitory concentration (MIC) of 
MMV367. A human dose that could maintain blood concentrations above Minimal 
Parasiticidal Concentration (MPC) for 100 h (corresponding to 2 parasite erythrocyte 
cycles) was identified as a target minimal efficacious dose for the treatment of acute 
uncomplicated Plasmodium falciparum malaria. Using allometry methods and PBPK 
modelling for predicting human PK profile and a typical human body weight of 60 kg, the 
predicted efficacious human dose of MMV367 after single-dose administration was 
estimated to be 440 mg. This dose is projected to maintain blood concentrations above 
the MPC90 in humans for at least 4.5 days and to be sufficient to reduce parasitaemia 
by 12-log in 50% of the population, while 100 and 30 mg would have similar efficacy for 
a two- and three-day QD treatment respectively. The parasite rate reduction was 
measured at ≥8 and 5 within the in vitro and ex vivo assays, respectively, and therefore, 
the value of 5 was retained to estimate the killing rate Emax (0.26 h-1). This is sufficient 
to reduce parasitaemia by 12-log in 4.5 days. 
The 3-day regimen is proposed as it is in-line with the duration of treatment for the current 
standard of care (SoC) for uncomplicated malaria. Although a single dose cure for 
uncomplicated malaria is the ideal product profile, a QD regimen that is taken for 2 to 3 
days would offer significant benefits over SoC in terms of efficacy and adherence if it 
overcomes the existing resistance to the current SoC (which has to be given multiple 
times a day). Furthermore, extended exposures will allow the assessment of tolerability 
and safety in the case of extended exposure in the patient population due to drug-drug 
interactions or co-morbidities, which is especially important due to the fact that the 
malaria burden disproportionately affect regions with fragile health systems where 
aftermarket drug monitoring may be less robust. 
Rationale for Highest Proposed Dose 
The rational for the highest proposed dose in Part 1 is based on:  
1. The predicted human efficacious exposure (AUC(0-inf) = 80 µg.h/mL) for a single 
dose/single cure of acute uncomplicated malaria, which is anticipated to be 
achieved with a dose of approximately 440 mg 
2. The need to document safety and tolerability of MMV367 at supratherapeutic 
exposures in humans in order to account for PK variability (intrinsic and extrinsic 
factors) in the target population 
3. The toxicity profile of MMV367 observed in preclinical species, which showed 
monitorable toxicity and an absence of life-threatening events  
4. The NOAEL in the two GLP species (rat and dog):  
− The cumulative exposure at NOAEL (100 mg/kg/day) in female rats was 
4270 µg.h/mL 
− The cumulative exposure at NOAEL (300 mg/kg/day) in male rats was 
3511 µg.h/mL 
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− The gender averaged cumulative exposure at NOAEL (300 mg/kg/day) in 
dogs was 1250 µg.h/mL (respectively, 1155 µg.h/mL in females and 
1344 µg.h/mL in males) 
Therefore, the exposure at NOAEL of the most sensitive species was identified from the 
7-day GLP toxicology study in dogs as the highest acceptable human exposure. The 
corresponding exposure of 1250 µg.h/mL is the cumulative AUC(0-168) of the parent 
drug MMV367 observed in the 7-day GLP dog study (Average cumulative AUC(0-168) 
calculated as follows: (AUC on Day 1 [AUCD1] + AUC on Day 7 [AUCD7]) / 2*7)). This 
would correspond to a theoretical HED of 6500 mg, assuming a linear PK from 100 to 
2000 mg.  
Based on the predicted human efficacious exposure, the need to document a safety 
window above that exposure and the anticipated human dose levels, the human AUCcap 
identified for this FIH study (376 µg.h/mL) was calculated as the predicted exposure 
(AUC(0-inf), assuming dose linearity from 100 to 2000 mg) for a theoretical dose of 
2000 mg. This proposed AUCcap is therefore 3-fold below the cumulative AUC identified 
at dog NOAEL (1250 ng.h/mL). Of note, based on the PBPK model, which suggests a 
less than dose-proportional increase in exposure, the highest dose of 2000 mg would 
result in a lower AUC(0-inf) of 208 µg.h/mL.  
For the multiple-dose part (Part 3), a dose of 200 mg every 24 h for 3 days would result 
in an AUC(0-inf) of 114 µg.h/mL and a safety factor of 3 to the AUCcap and a margin of 
11 to the cumulative AUC for the NOAEL from the dog study. 
The simulated exposure in human along with exposure multiples compared to NOAEL 
exposure in the most sensitive species are presented in Table 2. Exposure multiples for 
AUC are presented using two different methods. The standard method compares 
AUCtau(24h),ss in animal to AUC(0-inf) in human. Given the current goal of developing 
a single dose combination regimen (single dose-single cure treatment) and/or a 
combination regimen of up to 3 days treatment (QD administration) and the fact that the 
steady-state will never be reached, the cumulative method comparing AUC(0-168) in 
animal to AUC(0-inf) was considered more relevant in this case. Therefore, the exposure 
multiple at the top dose of 2000 mg is at least 6 for AUC (using a cumulative method). 
Additionally, the findings in animal toxicological species were non-adverse, monitorable 
and reversible [3]. Therefore, these increments are considered safe. Nevertheless, 
available PK data will be reviewed after each cohort to confirm that the observed AUC is 
comparable to the AUC simulated using the PBPK model and dose adjustments will be 
made, if required, before proceeding to the next cohort to ensure that the mean group 
exposure of the subsequent cohort will not exceed the highest achievable human 
exposure (AUCcap) of 376 µg.h/mL and/or the Cmaxcap of 23.8 µg/mL. 
Selecting mean group values for human AUC(0-inf)cap and Cmaxcap in this FIH is 
considered acceptable due to the nature of the preclinical observations (GI toxicity, 
increased blood pressure/heart rate and decreased respiratory function) in the two GLP 
toxicology and safety pharmacology studies. These toxicities are not associated with 
steep dose-response relationship and are monitorable in humans. 
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Table 2 
Margins between the Clinical Doses Predicted Plasma AUC(0-inf) and 
Cmax, and the Exposure at NOAEL in the Most Sensitive Species (Dog) 
Proposed 
Dose 
(mg) 
Prediction in Human 
based on PBPK model 
Exposure multiple in dogs 
(NOAEL dose 300 mg/kg QD for 7 days) 
Cmax 
(µg/mL) 
AUC(0-inf) 
(µg.h/mL) 
Cmax  
(23.8 µg/mL)a 
AUC(0-168)  
(1250 
µg.h/mL) 
Cumulative 
methodb,c 
AUCtau(24h)-ss  
(192 µg.h/mL) 
Standard 
methodd 
Single dose 
100 mg 
0.7 
18.8 
34.0 
66.5 
10.2 
300 mg 
2.2 
55.5 
10.8 
22.5 
3.5 
750 mg 
5.0 
127 
4.8 
9.8 
1.5 
1500 mg 
7.7 
193 
3.1 
6.5 
1.0 
2000 mg 
8.2 
208 
2.9 
6.0 
0.9c 
Multiple dose 
200 mg 
QD × 3 
2.2 
112 
10.8 
11.2 
1.7 
a Cmax after last dose in dogs 
b Cumulative exposure method, AUC(0-168) / predicted AUC(0-inf) in humans. The average cumulative 
AUC(0-168) is calculated as follows: (AUCD1 + AUCD7) / 2*7. 
c The approach calculating safety margin based on the cumulative method is considered more relevant in 
our setting because the steady-state will never be reached due to the maximum 3-day QD treatment duration 
with a 19 h half-life.   
d Standard method: AUCtau(24h)-ss / predicted AUC(0-inf) in humans  
Note: AUCcap = 376 µg.h/mL, calculated exposure at 2000 mg assuming dose linearity from 100 to 2000 mg. 
6.3 
Population Rationale 
As this is a Phase I study assessing the PK, relative bioavailability and safety of 
MMV367, the most relevant population is healthy volunteers. Participants who are 
non-smokers without a history of alcohol or drug abuse or regular co-medication (except 
hormonal contraception and hormone replacement therapy [HRT]) are proposed to avoid 
interaction on drug metabolism and to avoid non-compliance.  
Due to the target population in endemic areas with a substantial proportion of young 
women suffering from acute uncomplicated malaria, efforts will be made to enrol women 
of childbearing potential (WOCBP) in Phase I studies. In accordance with ICH M3 at this 
early stage of development, reproductive and developmental toxicity studies have not 
yet been conducted and, therefore, the risk of teratogenicity with MMV367 is currently 
unknown. Embryofoetal development studies will be completed before initiation of 
Phase II trials in African patients. Given the current lack of standard reproductive toxicity 
studies, WOCBP enrolled in Phase I studies with MMV367 must have a negative 
pregnancy test at screening and admission and are required to use a double method of 
contraception as described in Section 9.4. 
As it is unknown whether MMV367 is found in semen and considering the current lack of 
fertility studies in animals, male study participants are also required to use highly 
effective contraception with their partner, if their partner is a WOCBP. Contraception 
requirements are detailed in Section 9.4. 
Based on the above considerations and target population, healthy non-pregnant and 
non-lactating female participants and healthy male participants, aged 18 to 55 years are 
considered suitable for this study. In order to reflect the majority patient population, 
efforts will be made to ensure a gender balance and to recruit participants of 
Sub-Saharan origins (i.e. both parents are black and are of sub-Saharan African origin). 
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6.4 
Risks and Benefits 
6.4.1 Risks Associated with MMV367 Administration 
There is currently no clinical experience with MMV367. Potential risks will be closely 
monitored as part of systematic safety evaluations being performed in this FIH study. 
Based on pre-clinical observations at toxicological doses in rats and dogs, potential risks 
associated with MMV367 administration are all monitorable in humans and consist of:  
• 
Gastrointestinal toxicity with symptoms such as nausea and vomiting 
• 
Cardiovascular effects with transient increased heart rate and blood pressure 
• 
Decreased respiratory function 
Gastrointestinal adverse reactions may manifest as epigastric/abdominal pain, 
nausea/vomiting, diarrhoea or constipation. 
Heart rate and blood pressure will be closely monitored in this study and will also include 
orthostatic evaluations. 
Effects on respiratory function may result in an increased resting respiratory rate. 
Measures to minimise the risks to healthy participants will include: 
• 
Selection of a starting dose below a dose level for which pharmacological effects are 
expected. 
• 
Sentinel dosing in the SAD cohorts (Part 1) and the multiple dose cohort(s) (Part 3); 
one participant on IMP and one participant on placebo. If safety and tolerability is 
acceptable, the remaining participants in each cohort can be dosed with a minimum 
interval of 96 h post-dose (Part 1) or 96 h post-final dose (Part 3) in the sentinel 
participants. 
• 
Progression to consecutive study parts or higher exposure dosing regimens only after 
evaluation of data from previous parts/cohorts and following approval from the safety 
advisory committee (SAC). 
• 
Close and regular clinical, laboratory and ECG monitoring of study participants. 
• 
Telemetry (Day 1 in Part 1 and Days 1 and Day 8 in Part 2) and Holter monitoring 
(up to 24 h post-dose on Day 1 in Part 1, up to 24 h post-dose on Days 1 and 8 in 
Part 2, and up to 24 h post-dose on Days 1 and 3 in Part 3) of each cohort/study part. 
• 
Pre-defined stopping rules based on emerging human safety and PK data. 
6.4.2 COVID-19 Related Risks and Risk Mitigation Measures 
The following risks and risk mitigating measures apply to parts of the study in which the 
study is conducted during the Coronavirus Disease 2019 (COVID-19) pandemic.  
6.4.2.1 IMP Related Risk 
Against the background of the COVID-19 pandemic, the potential risk of a participant 
developing COVID-19 has been considered in terms of the risk-benefit evaluation. The 
mode of action of the IMP – as an inhibitor of acyl CoA synthetase in Plasmodium – has 
been considered alongside available pre-clinical and clinical data (including class 
effects) and it is considered that a participant would not be at increased risk of either 
becoming infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; 
the virus that causes COVID-19) or experiencing a more severe illness. That is, the IMP 
has no known immunomodulatory effect that would confer an increased risk to healthy 
participants enrolled in the study. 
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6.4.2.2 General COVID-19 Related Risk Mitigation Measures 
General risk mitigation against COVID-19 will be implemented in accordance with 
Quotient’s monitoring and prevention control measures. 
COVID-19 testing may be performed based on current infection rates and availability of 
tests. If required, it is planned that testing will comprise an antigen test performed at 
screening and on Day -1. Testing time points may be changed and additional time points 
may be added throughout the study as required. The decision on COVID-19 testing and 
the definition of the testing time points are subject to change based on the current risk 
mitigation in place and will be agreed by the study team and documented in the 
Investigator Site File (ISF) via the Clinical Kick-Off Meeting minutes. 
The risk mitigation measures, where applicable, will be amended based on emerging 
government guidance. 
6.4.2.3 COVID-19 Vaccine-Related Risk 
Approved (including health authority conditional marketing authorisation) COVID-19 
vaccines e.g. killed, inactivated, peptide, DNA and RNA vaccines will not be permitted 
during the study.  
Based on the mechanism of action of the IMP, as an inhibitor of acyl CoA synthetase in 
Plasmodium, there is no perceived impact on the safety of the study participants or on 
the study objectives for participants who may receive these vaccines. It is also very 
unlikely that administration of the IMP would interfere with COVID-19 vaccination 
response; however, no specific pre-clinical or clinical investigations have been 
conducted at this point with MMV367.  
The emerging safety and efficacy data from millions of vaccinated people indicate that 
these vaccines have an excellent safety and efficacy record. In the broader interests of 
society and to limit the extent of the global pandemic, it is important that participants 
should receive a vaccine when it is offered to them. 
6.4.3 General Risks and Overall Risk-Benefit Assessment 
Collecting a blood sample from a vein may cause pain, swelling, bruising, 
light-headedness, fainting, and very rarely, clot formation, nerve damage and/or infection 
at the site of the needle stick. 
During cannulation, more than one attempt may be needed to insert the cannula in a 
vein of a participant and it is possible that bruising and/or inflammation may be 
experienced at the site of cannulation.  
Electrocardiogram (ECG) and Holter stickers, and telemetry electrodes on the 
participants' chests and limbs may cause some local irritation and may be uncomfortable 
to remove but participants will be closely monitored to ensure any local irritation does not 
persist. 
There is no benefit to the participants from taking part in this study. The development of 
a product to treat malaria or improve the treatment of malaria will be of benefit to patients 
with malaria. 
The overall risk benefit balance is therefore considered to be acceptable. 
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7 Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the safety and tolerability of single and 
multiple oral doses of MMV367 in healthy 
participants 
 
 
Incidence of adverse events (AEs), physical 
examination findings, and change from baseline 
for vital signs, electrocardiograms (ECGs) and 
laboratory safety tests. 
Secondary 
To assess the pharmacokinetics (PK) of single 
and multiple doses of MMV367 in plasma 
(Parts 1, 2 and 3) 
 
 
PK parameters such as AUC, Tmax, Cmax, CL/F, 
Vz/F, T1/2 and AR, when applicable 
To assess the effect of a high-fat meal on the PK 
of a single dose of MMV367 in healthy 
participants (Part 2 only) 
 
PK parameters such as AUC, Tmax, Cmax and 
Frel, as appropriate, under fed and fasted 
conditions 
Exploratory  
To assess the PK of single dose of MMV367 in 
urine (Part 1 only) of healthy participants 
(optional)a 
 
 
Urine PK parameters such as Ae, and derived 
plasma PK parameters such as CLr, when 
applicable 
To assess exposure response relationship for 
potential effects of MMV367 on ECG intervals 
(QT, QTcF, QTcB, PR, QRS)b 
 
 
ECG intervals, MMV367 plasma concentrations 
(time-matched) 
To investigate metabolite(s) of MMV367 in healthy 
participantsa 
 
Metabolite characterisation for MMV367 in 
plasma and urine, when applicable 
To evaluate the taste attributes (smell, sweetness, 
bitterness, flavour, mouthfeel/texture, grittiness 
and aftertaste) and overall acceptability of the IMP 
(Part 1 only) 
Taste questionnaire score, based on a 9-point 
Likert scale assessing the acceptability for each 
taste attribute (smell, sweetness, bitterness, 
flavour, mouthfeel/texture, grittiness, and 
aftertaste) and overall acceptability for each dose 
level of MMV367 
a Depending on availability of the data, these objectives may be reported in an addendum to the final study 
Clinical Study Report (CSR) or in a separate report. 
b This objective will be reported in a separate cardiac safety report and will not be part of the final study CSR 
8 Study Design 
The study is divided into Parts 1, 2 and 3. For each of the three parts, participants will be 
screened within 28 days prior to first admission to the clinical unit on the morning of 
Day -1. Each participant will receive verbal and written information followed by signing 
of the informed consent form (ICF) prior to any screening procedures taking place. 
8.1 
Study Plan 
8.1.1 Study Plan: Part 1 – Single Ascending Dose Cohorts 
Part 1 will be a double-blinded, randomised, placebo-controlled, SAD study, which will 
comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E will be optional), with 
8 participants in each cohort. Participants will be randomly assigned to receive a single 
oral dose of either active IMP (6 participants) or placebo (2 participants) to assess its 
safety, tolerability and PK profile. Each participant will take part in one cohort. The data 
obtained from each cohort (safety and PK) will undergo a formal review by the SAC (see 
Section 8.2). The SAC will determine if it is safe to proceed with the next dose/cohort. 
Following review of the emerging PK data from each preceding cohort, if results suggest 
that the exposure plateau has been reached, the next planned cohort will not be 
conducted. Similarly, if PK predictions suggest that this exposure plateau would be 
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exceeded at the next cohort/dose level, a lower dose than originally anticipated will be 
proposed. 
It is planned to enrol 8 healthy male and female participants per cohort to ensure data in 
a minimum of 4 participants (per cohort) on active IMP. A participant will be considered 
evaluable if they have received study drug and completed safety and PK assessments 
up to 96 h post-dose. 
In each cohort, participants will be dosed on Day 1 and will remain resident in the clinical 
unit until discharge on Day 5. They will attend the clinical unit for a return visit on Day 7 
and again on Day 15 (± 1 day) for end of study assessments. Blood samples will be 
collected at regular intervals for PK analysis and safety from Day 1 to discharge from the 
study on Day 15 (± 1 day), as detailed in Appendix 2. Each cohort will follow the same 
study design (Figure 1). 
Figure 1 
Study Sequence: Part 1 (Cohorts 1A to 1E) 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Dose 
Day 1 
 
Discharge 
Day 5  
 
Return Visit  
Day 7 
 
End of Study Visit 
Day 15 (± 1 day) 
Each participant will take part in one cohort and will receive one of the regimens 
presented in Table 3, according to the randomisation schedule. 
Table 3 
Description of Regimens: Part 1 
SAD Cohort 
Regimen 
IMP 
Dose 
Route of 
Administration 
1A 
1 
MMV367 or 
placebo 
100 mg 
Oral, Fasted 
1B 
2 
MMV367 or 
placebo 
300 mga 
Oral, Fasted 
1C 
3 
MMV367 or 
placebo 
750 mga 
Oral, Fasted 
1D 
4 
MMV367 or 
placebo 
1500 mga 
Oral, Fasted 
1E 
Optional 
5 
MMV367 or 
placebo 
2000 mga 
Oral, Fasted 
a Predicted dose 
Details of the IMPs are provided in Section 5.2.  
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There will be a blinded interim review of the safety, tolerability and PK data after each 
cohort prior to the dose decision for subsequent cohorts. Full details of the interim data 
reviews are provided in Section 8.2. 
Participants will also complete a written taste/palatability questionnaire individually and 
privately following administration of the IMP (see Section 13.3). In the evening of Day -1, 
participants will be trained to respond to a sample questionnaire using a suitable example 
fluid (e.g. orange juice/squash). On the morning of Day 1, participants will brush their 
teeth using tap water (toothpaste not permitted). In order to evaluate taste, participants 
will hold the IMP in their mouth and swirl it around for 10 to 15 sec before swallowing. 
Immediately after swallowing, they will complete a taste questionnaire individually and 
privately. 
8.1.2 Study Plan: Part 2 – Food Effect Cohort 
Part 2 will be an open-label, randomised, balanced two-period crossover, food effect 
evaluation. The effect of food on the PK of MMV367 will be explored in Part 2 by 
administering a single dose of MMV367 after a high-fat breakfast, as per FDA guidance 
(Appendix 8), and a single dose of MMV367 in the fasted state. 
Each participant will receive 2 single doses of MMV367. In Period 1, participants will be 
randomised 
to 
1 
of 
2 
treatment 
sequences 
(Regimen 
6/Regimen 
7 
or 
Regimen 7/Regimen 6). If a participant is randomised to receive MMV367 in the fasted 
state (Regimen 6) in Period 1, they will receive MMV367 in the fed state (Regimen 7) in 
Period 2 and vice versa. 
It is planned to enrol 8 healthy male and female participants to ensure data in a minimum 
of 6 participants. A participant will be considered evaluable if they have received study 
drug and completed safety and PK assessments up to 96 h post-dose in both periods.  
Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and 
will remain resident in the clinical unit until discharge on Day 12. They will attend the 
clinical unit on Day 14 (± 1 day) for end of study assessments. Based on emerging PK 
data from Part 1, the washout period between the Period 1 and Period 2 doses may be 
extended. Blood samples will be collected at regular intervals for PK analysis and safety 
from Day 1 to the end of study visit on Day 14 (± 1 day), as detailed in Appendix 3. 
The study design for Part 2 is presented in Figure 2. 
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Figure 2 
Study Sequence: Part 2 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Period 1 Dose 
Day 1 
 
Period 2 Dose 
Day 8 
 
Discharge 
Day 12 
 
End of Study Visit 
Day 14 (± 1 day) 
Each participant will receive Regimens 6 and 7, presented in Table 4, according to the 
randomisation schedule. 
Table 4 
Description of Regimens: Part 2 
Food Effect 
Cohort 
Period 
Regimen 
IMP 
Dosea 
Route of 
Administration 
2A 
1 and 2 
(randomised) 
6 
MMV367 
XX mg 
Oral, Fasted 
7 
MMV367 
XX mg 
Oral, Fed 
Details of the IMPs are provided in Section 5.2.  
a The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of 
MMV367 and a safe exposure window has been established in Part 1. The dose for Regimens 6 and 7 will 
be the same. 
8.1.3 Study Plan: Part 3 – Multiple Dose Cohort(s) 
Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A 
total of 8 participants per cohort will receive once-daily doses of MMV367 (6 participants) 
or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability 
and PK profile of multiple dosing.  
It is planned to enrol 8 healthy male and female participants to ensure data in a minimum 
of 4 participants on active IMP. A participant will be considered evaluable if they have 
received study drug and completed safety and PK assessments up to 96 h post-final 
dose. 
Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the 
clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on 
Day 9 and again on Day 17 (± 1 day) for end of study assessments. Blood samples will 
be collected at regular intervals for PK analysis and safety from Day 1 to discharge from 
the study on Day 17 (± 1 day), as detailed in Appendix 4. Each cohort will follow the 
same study design (Figure 3). 
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Figure 3 
Study Sequence: Part 3 (Cohorts 3A to 3C) 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Dose 
Days 1, 2 and 3 
 
Discharge 
Day 7  
 
Return Visit  
Day 9 
 
End of Study Visit 
Day 17 (± 1 day) 
Each participant will receive one of the regimen(s) presented in Table 5 according to the 
randomisation schedule. 
Table 5 
Description of Regimens: Part 3 
Multiple Dose 
Cohort 
Regimen 
IMP 
Dosea 
Route of 
Administration 
3A 
8 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
3B 
Optional 
9 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
3C 
Optional 
10 
MMV367 or 
placebo 
XX mg for 3 days 
Oral, Fasted 
Details of the IMPs are provided in Section 5.2. 
a The dose(s) administered in Part 3 will be determined after review of the data from Part 1. 
Parts 2 and 3 may be conducted before completion of Part 1 provided that this is justified 
by PK and safety data obtained from completed cohorts in Part 1. The total amount of 
active IMP administered as multiple doses (i.e. cumulative 3-day dose) in Part 3 will be 
no greater than the maximum safe and well tolerated dose in Part 1, dosed at a single 
dose level. Parts 2 and 3 may be conducted in parallel. 
The data obtained (safety and PK) from the multiple dose administration will undergo a 
formal review by the SAC after all 8 participants have completed the study. 
Consequently, Part 3 may be extended to evaluate a second and/or third dose level in a 
3-day QD regimen. 
Parts 1 and 3 will follow a sentinel dosing design. On the first day of dosing in each cohort 
in Part 1 and in Part 3, only 2 (sentinel) participants will be dosed. The randomisation 
schedule will be constructed such that 1 of the participants dosed on the first day will 
receive MMV367 and 1 will receive placebo. After review of the safety data up to 96 h 
post-dose for SAD cohorts in Part 1 and up to 96 h post-final dose in Part 3, the 
investigator, or medically qualified designee who is familiar with the study protocol and 
IB, and medical monitor or delegate (with approval from the sponsor’s medical director 
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or delegate) will decide whether to proceed with dosing the remaining participants in the 
cohort. 
8.2 
Criteria for In-Study Decisions 
In-study decisions will be made by the safety advisory committee (SAC), which will 
always comprise the investigator, the medical monitor, the sponsor’s medical director, 
and a PK expert where appropriate. 
8.2.1 Decision Points  
The following in-study decisions will be made during this study: 
• 
Dose selection for Cohorts 1B to 1E in Part 1 
• 
Progression from Cohort 1D to 1E in Part 1 
• 
Washout period duration between periods in Part 2 
• 
Dose selection for Parts 2 and 3 
• 
Changes to safety and/or PK time points, if there is reason to believe that the change 
might improve the quality of the data as a consequence of review of emerging data 
• 
Progression from Cohort 3A to further multiple dose levels in Part 3  
8.2.2 Criteria for Dose Decision 
Part 1: Single Ascending Dose Cohorts 1A to 1E 
Progression to the next dose cohort will be permitted after review of safety, tolerability 
and PK data suggests that it is safe to do so. Quotient will provide data to the SAC in 
accordance with Quotient’s standard operating procedure (SOP) on interim dose 
decision making and dose escalation. The decision will be documented and signed by 
the investigator as per Quotient’s current SOP. Evidence of the decision will be retained 
in the ISF and Trial Master File. 
For dose escalation to proceed, data must be available from a minimum of 6 participants 
who have completed the planned safety assessments up to 7 days after dosing and 
planned PK assessments up to 144 h after dosing to ensure at least 4 participants had 
received active IMP. Dose increases will only be made after a complete review of all data 
collected from the previous dose group by the SAC.  
It is planned that the dose will be escalated for each subsequent cohort; however, the 
SAC may also agree to enrol additional participants for an intermediate dose level if 
warranted or may agree to reduce the dose with no limit on the possible extent of 
reduction. Any decision to investigate an intermediate or reduced dose level will be fully 
documented. 
The decision to proceed to the next dose level will be based on safety, tolerability and 
available PK data. The following data are required: 
• 
AEs 
• 
Vital signs 
• 
Safety laboratory results 
• 
ECGs 
• 
Physical examination findings 
• 
Plasma concentrations of MMV367 
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• 
Interim PK parameter estimations (Tmax, Cmax, AUC(0-24), AUC(0-48), 
AUC(0-last), AUC(0-inf), T1/2, where possible and appropriate) 
Rules for dose decision are as follows: 
• 
Dose increments between SAD cohorts will be a maximum of 3-fold and dose 
escalation may be halted in the SAD cohorts if an exposure plateau appears to have 
been reached 
• 
Dose increments between multiple dose optional cohorts will be no more than 3-fold 
• 
No dose selected for SAD or MAD will be expected to result in a mean group 
exposure at the next dose level (based on predicted human PK and assuming 
dose-linearity) greater than AUC(0-inf) 376 µg.h/mL, and Cmax 23.8 µg/mL based 
on the NOAEL in dogs and the corresponding human therapeutic exposure 
• 
The predicted exposure (AUC(0-inf)) of the cumulative dose after a 3-day treatment 
will not exceed that of a single dose evaluated in Part 1 
• 
The study will be halted (see Section 8.5) and thus a further dose decision will not 
be made if: 
− One or more participants experience an IMP-related serious adverse event 
(SAE) 
− Two or more participants experience an IMP-related severe or clinically 
significant non-serious AE at the same dose level/same cohort 
If, following review by the SAC it is deemed acceptable to continue dose escalation 
above the defined maximal dose or exposure limit, a substantial amendment with 
relevant data will be submitted for approval to the Medicines and Healthcare products 
Regulatory Agency (MHRA) and ethics committee (EC). 
Progression from Part 1 (SAD) to Part 2 (Food Effect).  
For the dose level decision to be made for Part 2, data must be available from a minimum 
of 6 participants who have completed the planned safety assessments up to 7 days after 
dosing and planned PK assessments up to 144 h after dosing (to ensure at least 
4 participants had received active IMP), at a relevant dose level in Part 1. A “relevant 
dose level” is defined as a dose that demonstrated acceptable safety/tolerability 
(i.e. exposure levels at which no study specific criteria stopping dose progression and/or 
escalation were met) at a mean exposure that is not anticipated to be exceeded by the 
dosing regimen in Part 2, taking into account a potential bioavailability increase to 100% 
after a high-fat breakfast. 
Progression from Part 1 (SAD) to Part 3 (Multiple Dose).  
For the dose level decision to be made for Part 3, data must be available from a minimum 
of 6 participants who have completed the planned safety assessments up to 7 days after 
dosing and planned PK assessments up to 144 h after the final dose (to ensure at least 
4 participants had received active IMP), at a relevant dose level in Part 1. The total dose 
in Part 3 (3 × QD dose) will not exceed a dose of MMV367 administered and evaluated 
as a single dose in Part 1, and the predicted exposure will not exceed an exposure 
observed and determined to be safe in Part 1. If a less than dose-proportional increase 
in exposure is observed in Part 1 (SAD), the proposed dose(s) for Part 3 may be adjusted 
to ensure the equivalent exposures between SAD and MAD. 
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8.2.1 Criteria for Sentinel Dosing Decisions 
For all cohorts following a sentinel design (Parts 1 and 3) the decision to proceed with 
the main group will be made by the investigator, based on safety data until 96 h post-dose 
(Part 1) or 96 h post-final dose (Part 3) in the sentinel participants. The investigator or 
medically qualified designee who is familiar with the study protocol and IB, and medical 
monitor or delegate (with approval from the sponsor’s medical director or delegate) will 
decide whether to proceed with dosing the remaining participants in the cohort.  
8.3 
Participant Withdrawal 
If a participant wishes to leave the study at any time, they will be permitted to do so. 
Every 
reasonable 
effort 
will 
be 
made 
by 
Quotient 
to 
complete 
final 
assessments/discharge procedures. Quotient will advise the sponsor of the withdrawal 
of any participant from the study. 
Early withdrawal is defined as the date of the decision to withdraw the participant from 
the study. Participant completion is defined as the date of the last procedure conducted 
or last contact (e.g. discharge from the study or unscheduled visit) for that participant. 
If a participant requests to leave the clinical unit earlier than the planned discharge time 
e.g. due to unforeseen personal circumstances, but aims to return to the clinical unit to 
complete the study, this will be documented as a participant self-discharge and a protocol 
deviation. The participant must complete the planned assessments/discharge 
procedures before discharge from the clinical unit, and may return for the next study 
period/assessments, as planned following agreement between the sponsor and the 
investigator.  
Participants in Part 1 will receive a single dose in the study; therefore, after an individual 
participant has received a dose of IMP, withdrawal of that participant from further dosing 
is not possible. Participants will be monitored for the criteria listed below, which may 
require their withdrawal from some or all study procedures if continuation is not in their 
best interests, except when the withdrawal is a result of withdrawal of consent.  
Participants in Parts 2 and 3 will be withdrawn from the study drug for the following 
reasons: 
• 
Experiencing a serious or severe AE including but not limited to: 
− corrected QT interval by Fridericia’s formula (QTcF) of >500 msec or 
increase in QTcF of >60 msec from baseline (confirmed following a repeat 
ECG) 
− alanine aminotransferase (ALT) concentration >3 × the upper limit of the 
reference range (confirmed following a repeat ALT blood test) 
• 
Pregnancy (see Section 9.5) 
• 
Termination of the study 
• 
Upon the participant’s request (withdrawal of consent) 
• 
Significant deviation from the protocol 
• 
Concurrent illness that would adversely affect participant safety or data integrity or 
requirement for prohibited medication 
• 
At the discretion of the investigator 
For the purpose of withdrawal criteria, baseline will be considered as the last available 
assessment prior to first dose. 
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For a participant who withdraws because of an IMP-related AE, every effort will be made 
to ensure the participant completes discharge procedures.  
Early withdrawal for safety reasons will be distinguished from withdrawal of consent by 
the participant to participate in any further activities. 
8.4 
Participant Replacement 
In Part 1, up to 2 replacement participants may be used per cohort. The maximum 
number of participants that may be dosed is 50 (8+2 per cohort). 
In Part 2, up to 4 replacement participants may be enrolled into the study. The maximum 
number of participants that may be dosed in Part 2 is 12 (8+4). 
In Part 3, up to 2 replacement participants per cohort (if optional cohorts are utilised) may 
be enrolled into the study. The maximum number of participants that may be dosed is 
30 (8+2 per cohort). 
Any participant withdrawn due to an IMP-related AE will not be replaced. 
Participants withdrawing for other reasons may be replaced as required by agreement 
between the investigator and sponsor to ensure sufficient evaluable participants. 
8.5 
Stopping Criteria 
Cohort stopping rules 
Dose escalation, as well as continued dosing within any given cohort, will be paused and 
may be halted based on full review of all available clinical safety data if any of the 
following occur: 
• 
Two or more participants in the same cohort experience an AE assessed as severe 
• 
Two or more participants with QTcF >500 msec and/or an increase in QTcF 
>60 msec considered related to IMP administration 
• 
At least 2 participants in the same cohort with demonstrated recurrent or persistent 
post-dose orthostatic hypotension (i.e., either a drop of systolic blood pressure [SBP] 
≥20mmHg or diastolic blood pressure [DBP] ≥10mmHg after 3 min standing) and/or 
symptomatic hypotension (lightheadedness, weakness, blurry vision, dizziness or 
fainting upon standing) requiring medical intervention 
Overall study stopping rules 
Enrolment into the study will be placed on hold and dosing will be halted if any of the 
following occur cumulatively across all of the cohorts 
• 
At least one IMP-related SAE 
• 
Two severe non-serious adverse reactions considered as, at least, possibly related 
to the IMP administration in two subjects in the same cohort, independent of within 
or not within the same system-organ-class are observed. 
• 
The investigator and/or the study sponsor considers that the number and/or severity 
of AEs, abnormal safety monitoring test, or abnormal laboratory findings justify 
putting the study on hold. 
Relatedness to IMP will be determined by the investigator.  
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If the study is halted, a temporary halt will be submitted to the MHRA and EC in the form 
of a substantial amendment. The study may be resumed or terminated; however, it will 
not be resumed until a further substantial amendment to resume the study is submitted 
and approved by MHRA and EC. 
8.6 
Study Termination 
After the start of protocol activities but prior to the commencement of dosing, the study 
may be terminated by the sponsor and investigator without consultation with the 
Medicines and Healthcare products Regulatory Agency (MHRA) and EC. Notification of 
early termination must be provided to the MHRA and EC immediately and at the latest 
within 15 days after the study is terminated, clearly explaining the reasons. A description 
of follow-up measures taken for safety reasons, if applicable, will also be provided. 
If the study is abandoned prior to commencement of any protocol activities, the 
investigator or sponsor must notify the EC and MHRA by letter outlining the reasons for 
abandonment of the trial. 
Once exposure to dosing has begun, the study will be completed as planned unless the 
following criteria are satisfied that require a temporary halt or early termination of the 
study:  
• 
The occurrence of serious or severe AE(s), as defined in Section 8.5, if considered 
to be related to the IMP, as defined in Section 14.2. 
• 
New information regarding the safety of the IMP that indicates a change in the 
risk/benefit profile for the compound, such that the risk/benefit is no longer acceptable 
for participants participating in the study. 
• 
Significant violation of Good Clinical Practice (GCP) that compromises the ability to 
achieve the primary study objectives or compromises participant safety. 
If any of the above occurs, the study will be terminated if careful review of the overall 
risk/benefit analysis described in Section 6.4 demonstrates that the assumptions have 
changed and that the overall balance is no longer acceptable. In these circumstances 
termination can only take place with the agreement of the investigator and sponsor. The 
MHRA and EC will be informed of study termination. 
If it becomes necessary to consider termination of the study after dosing has begun, 
dosing may be suspended pending discussion between the investigator and sponsor. 
Dosing will be stopped immediately on safety grounds. 
The study may be terminated or suspended at the request of the MHRA or EC. 
8.7 
Lost to Follow-up 
A participant will be considered lost to follow-up if they fail to return for scheduled visits 
and cannot be contacted by the clinical unit.  
If a participant fails to return to the clinical unit for a required study visit: 
• 
The clinical unit must attempt to contact the participant and reschedule the missed 
visit as soon as possible. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (e.g. three telephone calls on 
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three separate occasions and, if necessary, an email or letter to the participant’s last 
known email/postal address). These contact attempts should be documented in the 
participant’s source. 
• 
If the participant cannot be contacted, they will be considered lost to follow-up.  
8.8 
Treatment Assignment and Randomisation 
Parts 1 and 3 will be randomised (IMP/placebo) and double-blinded. Part 2 will be 
randomised (fed/fasted) and open-label. A randomisation schedule will be produced for 
each study part. 
Instructions to dispense and dose will be produced prior to dosing using the 
randomisation schedule and will be retained in the ISF. 
For Part 2, the original randomisation schedule and proof of quality control procedures will 
be held by the Data Sciences department at Quotient until the study is archived, at which 
time the randomisation materials will be retained in the ISF. 
Using computer-generated randomisation schedules, participant numbers will be 
allocated to treatment regimens in a 6:2 ratio (MMV367:placebo) in each cohort (Part 1) 
or part (Part 3). In Part 2, the allocation will be balanced with 8 participants assigned to 
receive MMV367 in both the fed and fasted states. Participants will be randomised to 
1 of 2 treatment sequences (Regimen 6/Regimen 7 or Regimen 7/Regimen 6) on Day 1 
prior to dosing in the first period. 
For participants in Parts 1 and 3, a sentinel group of 2 participants will be dosed ahead 
of the remaining participants in each cohort. For each cohort, using a 
computer‑generated randomisation schedule, the first 2 participant numbers will be 
allocated to active or placebo in a 1:1 ratio (i.e. 1 participant will be randomly assigned 
to receive MMV367 and 1 participant will be randomly assigned to receive placebo). The 
remaining 6 participant numbers will be allocated to active or placebo in a 5:1 ratio 
(i.e. 5 participants will be randomly assigned to receive MMV367 and 1 participant will 
be randomly assigned to receive placebo). 
Participants will be randomised immediately before administration of the first dose. 
8.8.1 Participant Numbers 
Participant numbers will be allocated on the morning of dosing according to the code 101 
to 140 in Part 1, 201 to 208 in Part 2, and 301 to 324 in Part 3 using the lowest number 
available. Replacement participants will be allocated participant numbers 901 to 940 in 
Part 1, 801 to 808 in Part 2 and 701 to 724 in Part 3, where the last two digits are the 
same as those of the original participant (e.g. if Participant 105 withdraws, the 
replacement will have Participant Number 905 and will receive the same regimen as 
Participant 105).  
Participant numbering by study part and cohort is provided in Table 6. 
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Table 6 
Participant Numbers 
Study Part 
Cohort 
Participant Numbers 
1 
1A 
101–108 
1B 
109–116 
1C 
117–124 
1D 
125–132 
1E (optional) 
133–140 
2 
2A 
201–208 
3 
3A 
3B (optional) 
3C (optional) 
301–308 
309–316 
317–324 
8.8.2 Blinding  
Parts 1 and 3 of the study are double-blinded. Treatment assignment will not be known 
to the participants, the sponsor or the staff who are involved in the clinical evaluation of 
the participants and the analysis of data. If appearance matching of the placebo is not 
possible then masking and/or unblinded dosing teams will be used to preserve the study 
blind. Further details of these steps will be contained in the study specific blinding plan, 
which will be approved prior to dosing. The randomisation schedules and disclosure 
envelopes will be generated by an unblinded statistician at Quotient according to 
Quotient’s SOPs. The unblinded statistician will not be involved in any decisions relating 
to populations for analysis prior to unblinding. Prior to database lock and unblinding, all 
original randomisation materials, including the original final signed and dated 
randomisation schedule, will be held by the Quality Assurance (QA) department at 
Quotient. The Data Sciences department will not have access to the randomisation 
schedule before database lock and unblinding.  
Interim PK parameter estimations will be performed using bioanalytical data applied with 
participant aliases in order to maintain the study blind.  
There may be instances where interim PK data have the potential to be treatment 
revealing e.g. missed blood sampling occasions. In these cases, every effort will be 
made by the pharmacokineticist to maintain the study blind by appropriate presentation 
of data to the study team. Data demonstrating extremes of exposure will always be 
presented, regardless of the potential to reveal the study blind. To permit selection of the 
dose level, individual data may be made available in full if judged necessary by the 
investigator or sponsor regardless of the potential to reveal study blind. 
The unblinded Qualified Person or designee at the clinical site will receive a copy of the 
final randomisation schedule for preparation of the study drug and preparation of the 
instructions to dispense and dose. A copy of the randomisation schedule will also be 
made available to the laboratory performing the bioanalysis to allow selective analysis of 
drug concentrations (for Parts 1 and 3) and to the pharmacovigilance provider for 
analysis of pharmacovigilance. 
Two sets of disclosure envelopes (i.e. sealed envelopes containing individual participant 
randomisation details) will be provided. One set will be held in the clinical area and the 
other retained in the ISF. These may be used in the event of an emergency by the 
investigator or delegate. Any request for information on the randomisation schedule after 
initial issue must be made using a randomisation disclosure form, except in the case of 
emergency unblinding, which must be recorded on the emergency unblinding form. 
Access to study drug assignment will be immediately available if the investigator deems 
it necessary to break the study blind in the interest of a participant’s medical safety, in 
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case of a medical emergency, or if warranted during scheduled safety reviews. The 
medical monitor must be contacted within 24 h following disclosure of study drug 
assignment.  
Details of any disclosure of the randomisation schedule will be documented and retained 
in the ISF. The sponsor will be notified if the study blind is broken. 
The study blind will be broken after the study database has been locked and the safety 
population has been defined. Any subsequent request for issue of the randomisation 
schedule prior to unblinding must be made using a randomisation disclosure form. 
Part 2 of the study is open-label and therefore blinding is not required. 
9 Selection of Participants 
Participants will be recruited from the Quotient panel or by direct advertising to the public.  
Before participants are admitted to the clinical unit, The Over Volunteering Prevention 
System will be checked to ensure that each participant has not been dosed in a study 
within 90 days of the planned first dosing date of this study. 
9.1 
Informed Consent 
Participants will be provided with a written explanation of the study at least the day before 
the screening visit. A physician or nurse will explain to each participant the nature of the 
study, its purpose, expected duration and the benefits and risks involved in study 
participation. Participants will be informed that, for safety reasons, brief details of their 
involvement in the study may be revealed to other units and companies that carry out 
clinical studies nationally. Participants will then be given the opportunity to ask questions 
and will be informed of their right to withdraw from the study without prejudice. After this 
explanation and before entering the study, the participant will voluntarily sign an ICF. 
Until written consent has been obtained from the participant no study specific procedure 
or investigation will be performed. If an amendment is made to the participant information 
sheet (PIS), participants will be re-consented to the most current version of the ICF(s) 
where appropriate. 
9.2 
Inclusion Criteria 
Informed Consent and Compliance 
1. Must provide written informed consent 
2. Must be willing and able to communicate and participate in the whole study 
Demographics and Contraception 
3. Aged 18 to 55 years inclusive at the time of signing informed consent 
4. Must agree to adhere to the contraception requirements defined in Section 9.4 
Baseline characteristics  
5. Healthy males or non-pregnant, non-lactating healthy females. 
6. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening  
7. Weight ≥50 kg at screening 
Inclusion criterion 5 from the list above will be re-assessed at admission/pre-dose on 
Day 1.  
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9.3 
Exclusion Criteria 
Medical/Surgical History and Mental Health 
1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation 
excipients 
2. Presence or history of clinically significant allergy requiring treatment, as judged 
by the investigator. Hay fever is allowed unless it is active 
3. History of clinically significant cardiovascular, renal, hepatic, dermatological, 
chronic respiratory or gastrointestinal disease, neurological or psychiatric 
disorder, as judged by the investigator 
4. Blood pressure (supine) at screening or admission outside the range of 90 to 
140 mmHg systolic or 50 to 90 mmHg diastolic; and pulse rate outside the range 
of 45 to 100 bpm, unless deemed not clinically significant by the investigator 
5. A decrease of SBP ≥20 mmHg after 3 min standing and/or a decrease of DBP 
≥10 mmHg after 3 min standing, at screening (applies to Part 1 and Part 3 only) 
6. History or presence of known structural cardiac abnormalities, family history of 
long QT syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise 
related clinically significant cardiac events. Any clinically significant abnormalities 
in rhythm, conduction or morphology of resting ECG or clinically important 
abnormalities that may interfere with the interpretation of QT interval changes  
7. Presence of sinus node dysfunction, clinically significant PR interval prolongation 
(>210 msec), intermittent second- or third-degree atrioventricular block, complete 
bundle branch block, sustained cardiac arrhythmias including (but not limited to) 
atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with 
the exception of isolated extra systoles, abnormal T wave morphology which may 
impact on the QT/QTc assessment, or QTcF >450 msec. Participants with 
borderline abnormalities may be included if the deviations do not pose a safety 
risk, and if agreed between the sponsor’s medical monitor and the investigator 
8. Participants with a history of cholecystectomy or gall stones 
9. Participants with conditions that affect their ability to smell or taste (Part 1 only) 
including, but not limited to mouth ulcers, gum disease, nasal surgery and smell 
and/or taste disorders (e.g. dysosmia, dysgeusia, respiratory and/or sinus 
infection or cold)  
Physical Examination 
10. Participants 
who 
do 
not 
have 
suitable 
veins 
for 
multiple 
venepunctures/cannulation as assessed by the investigator or delegate at 
screening 
Diagnostic assessments 
11. Evidence of current SARS-CoV-2 infection 
12. Clinically significant abnormal clinical chemistry, haematology, coagulation or 
urinalysis as judged by the investigator (laboratory parameters are listed in 
Appendix 1). Participants with Gilbert’s Syndrome are not allowed.  
13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) 
or human immunodeficiency virus (HIV) 1 and 2 antibody results 
14. Females who are pregnant or lactating (all female participants must have a 
negative highly sensitive serum pregnancy test at screening and a negative urine 
pregnancy test at admission) 
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Prior Study Participation 
15. Participants who have received any IMP in a clinical research study within the 
90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, 
whichever is longer 
16. Participants who have previously been administered IMP in this study. 
Participants who have taken part in Part 1 are not permitted to take part in Parts 2 
and 3 and participants who have taken part in Part 2 are not permitted to take part 
in Part 3 
17. Donation of blood or plasma within the previous 3 months or loss of greater than 
400 mL of blood 
Prior and Concomitant Medication 
18. Participants who are taking, or have taken, any prescribed or over-the-counter 
drug or herbal remedies (other than up to 4 g of paracetamol per day, hormonal 
contraception or HRT) in the 14 days before first IMP administration (see 
Section 11.4) 
19. Participants who have received a COVID-19 vaccine within 7 days before first IMP 
administration 
Lifestyle Characteristics 
20. History of any drug or alcohol abuse in the past 2 years 
21. Regular alcohol consumption in males >21 units per week and females >14 units 
per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 
125 mL glass of wine, depending on type) 
22. A confirmed positive alcohol breath test at screening or admission 
23. Current smokers and those who have smoked within the last 12 months. A 
confirmed breath carbon monoxide reading of greater than 10 ppm at screening 
or admission 
24. Current users of e-cigarettes and nicotine replacement products and those who 
have used these products within the last 12 months 
25. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in 
Appendix 1) 
26. Participant with a vegan or vegetarian diet (Part 2 only)  
Other 
27. Male participants with pregnant or lactating partners 
28. A score of 20 or more on the Beck Depression Inventory (BDI-II), and/or a 
response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) [7]. 
Note, individuals with a BDI-II score of 17-19 may be enrolled, at the discretion of 
the investigator, if they do not have a medical history of psychiatric conditions and 
their mental state is not considered to pose additional risk to the health of the 
individual or to the execution of the trial and interpretation of the data 
29. Participants who are, or are immediate family members of, a study site or sponsor 
employee 
30. Failure to satisfy the investigator of fitness to participate for any other reason 
Exclusion criteria 2, 4, 6, 7, 11, 12, 14, 15, 16, 18, 19, 22, 23, 25, 27, 28 and 30 from the 
list above will be re-assessed at admission/pre-dose on Day 1.  
Healthy participants who do not meet the inclusion/exclusion criteria for the study will not 
be enrolled. 
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9.4 
Contraception and Restrictions 
Male Participants with Partners of Childbearing Potential 
Male participants who are sexually active with a partner of childbearing potential must 
use, with their partner, a condom plus an approved method of highly effective 
contraception from the time of informed consent until 94 days after the last IMP 
administration. This has been calculated based on 90 days (one cycle of 
spermatogenesis) plus 5 half-lives of the IMP. Five half-lives (based on predicted human 
half-life of 19 h) has been calculated as 4 days. 
The following methods are acceptable: 
• 
Partner’s use of combined (oestrogen and progestogen-containing) hormonal 
contraception associated with inhibition of ovulation:  
− oral  
− intravaginal  
− transdermal  
• 
Partner’s use of progestogen-only hormonal contraception associated with inhibition 
of ovulation:  
− oral  
− injectable/implantable 
− intrauterine hormone-releasing system  
• 
Partner’s use of intrauterine device  
• 
Vasectomised 
• 
Partner’s bilateral tubal occlusion 
These contraception requirements are considered to be more conservative than the 
guidance issued by the Heads of Medicines Agency: Clinical Trials Facilitation Group [8]. 
Males with Partners of Non-childbearing Potential 
There is a significant risk of drug exposure through the ejaculate (which also applies to 
vasectomised males) that might be harmful to sexual partners. Therefore, even if a male 
is sexually active with a partner of non-childbearing potential, they will be required to use 
a condom from first administration of IMP until after the end of study visit from the study. 
Female Participants of Childbearing Potential 
Female participants who are sexually active and of childbearing potential must use, with 
their partner, a double method of contraception, consisting of a highly effective method 
of birth control combined with a barrier contraceptive (condom) from the time of informed 
consent until 34 days after last IMP administration. This has been calculated based on 
30 days (one female menstrual cycle) plus 5 half-lives of the IMP. Five half-lives has 
been calculated as 4 days. 
The following highly effective methods are acceptable: 
• 
Combined (oestrogen and progestogen-containing) hormonal contraception 
associated with inhibition of ovulation:  
− oral  
− intravaginal  
− transdermal  
• 
Progestogen-only hormonal contraception associated with inhibition of ovulation 
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− oral  
− injectable/implantable 
− intrauterine hormone-releasing system  
• 
Intrauterine device  
• 
Vasectomised partner 
• 
Bilateral tubal occlusion 
Female Participants are not required to use any of the above contraceptive methods if 
their sexual partner is female. 
These contraception requirements are considered to be more conservative than the 
guidance issued by the Heads of Medicines Agency: Clinical Trials Facilitation Group [7]. 
All Participants (Male and Female Participants of Childbearing Potential) 
Alternatively, sexual abstinence is considered a highly effective method only if defined 
as refraining from heterosexual intercourse during the entire period of risk associated 
with the study treatments. The reliability of sexual abstinence needs to be evaluated in 
relation to the duration of the clinical trial and the preferred and usual lifestyle of the 
participant. 
Females of Non-Childbearing Potential  
Female participants who are not of childbearing potential do not need to use any 
methods of contraception. A woman is considered of childbearing potential unless 
postmenopausal or permanently sterile. Permanent sterilisation methods include 
hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal 
state is defined as no menses for 12 months without an alternative medical cause and 
confirmed by a follicle-stimulating hormone (FSH) result of ≥40 IU/L. 
9.4.1 Sperm Donation 
Male participants should not donate sperm for the duration of the study and for 94 days 
after last IMP administration.  
9.4.2 Egg Donation 
Female participants should not participate in egg donation from dosing, for the duration 
of the study and for at least 34 days after last IMP administration.  
9.5 
Pregnancy 
Participants will be instructed that if they/their partner becomes pregnant during the study 
or up to 3 months after final dose, this should be reported to the investigator. The 
investigator should also be notified of pregnancy occurring during the study but 
confirmed after completion of the study. In the event that a participant/participant’s 
partner is subsequently found to be pregnant after the participant is included in the study, 
then consent will be sought from the participant/partner and, if granted, any pregnancy 
will be followed and the status of mother and/or child(ren) will be reported to the sponsor 
after delivery. Any participant reporting a pregnancy during the study will be discontinued 
from the study treatment and every reasonable effort will be made by Quotient to follow 
up the pregnancy until delivery. 
A pregnancy notification form and follow-up will be completed. 
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9.6 
Additional Study Restrictions 
The following additional restrictions will be in place for the duration of the study: 
1. Participants must abstain from alcohol during the 24 h prior to screening and the 
24 h prior to admission until after the end of study visit  
2. Participants must not drink liquids or eat food containing grapefruit, cranberry, 
caffeine or other xanthines from 24 h prior to admission until after the end of study 
visit 
3. Participants should refrain from eating food containing poppy seeds for 48 h prior 
to screening and for 48 h prior to admission until after the end of study visit 
4. Participants must not take part in any unaccustomed strenuous exercise from the 
72 h before the screening visit and then from 72 h prior to admission until after the 
end of study visit 
5. Must not donate blood or plasma (outside of this study), from clinical unit 
admission, throughout the study duration, and for at least 90 days following last 
dose of study medication 
The additional restrictions above are not exclusion criteria; if non-compliance occurs, a 
protocol deviation will be completed.  
10 Study Procedures 
Study procedures will be performed as detailed in the study schedule of assessments in 
Appendix 2, Appendix 3 and Appendix 4, Appendix 5, Appendix 6 and Appendix 7, and 
in accordance with Quotient’s SOPs unless otherwise stated in this protocol. 
10.1 Screening 
Within the 28 days preceding first dose, all participants will be required to undergo a 
screening visit. Screening procedures will be carried out in accordance with the schedule 
of assessments in Appendix 2, Appendix 3 and Appendix 4. 
If the start of the study is delayed for any reason so that the interval between screening 
and first dose exceeds 28 days, all or part of the screening procedures will be repeated 
at the discretion of the investigator. 
Screening safety procedures such as safety bloods, ECGs, vital signs, carbon monoxide 
breath tests, alcohol breath tests and urinalysis can be repeated as clinically indicated 
under the discretion of the investigator or sub-investigator if there is a concern regarding 
a participant’s safety or eligibility to participate in the trial. 
10.1.1 Participant Re-Screening 
This study permits the re-screening of a participant who has discontinued the study as a 
pre-treatment failure (i.e. participant has not been randomised); the reason for failure 
must be temporary and expected to resolve. If re-screened, the participant must be 
re-consented. 
10.2 Admission and Pre-dose Procedures 
The identity of the participants will be confirmed at admission and pre-dose.  
In addition, the ongoing eligibility of participants will be re-assessed at 
admission/pre-dose, as described in Sections 9.2 and 9.3.  
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Admission/pre-dose safety procedures such as safety bloods, ECGs, vital signs, 
urinalysis, pregnancy and drugs of abuse tests can be repeated as clinically indicated 
under the discretion of investigator or sub-investigator if there is a concern regarding a 
participant’s safety or eligibility to participate in the clinical trial. 
Reserve participants for the first dose occasion, in any group, will not require admission 
procedures to be repeated, if dosing is within 2 days.  
If dosing is delayed, participants who have completed admission procedures do not need 
admission procedures to be repeated if dosing is within 2 days and the participants have 
remained resident in the clinical unit. 
The participants will be admitted to the clinical unit on the morning before dosing 
(Day -1).  
In addition, participants may be required to visit the clinical unit on Day -1 prior to 
admission to the clinical unit for SARS-CoV-2 antigen tests (if required; see 
Sections 6.4.2.2 and 14.5.8). Test results must be available prior to dosing. 
The admission and pre-dose procedures are presented in Appendix 2, Appendix 3 and 
Appendix 4. 
10.3 Study Day Procedures 
10.3.1 Blood Volume 
The number and timing of samples may be amended following any interim PK parameter 
estimations. However, in this case, the total blood volume for each participant will not 
exceed 550 mL in a 4-week period.  
The first 0.5 mL of blood withdrawn via cannula will be discarded. 
10.3.2 Timing of Procedures 
There are times where the protocol requires more than one procedure to be completed 
at the same time point. In these instances, the following will apply to post-dose time 
points: 
• 
PK samples should take priority (i.e. taken at the nominal time point) over other 
procedures scheduled at the same time point 
• 
Resting periods will be completed prior to ECGs and no other procedures will be 
performed within this time window 
• 
ECGs should be taken prior to vital signs when both measurements are scheduled 
at the same time point  
• 
Other assessments, e.g. physical examinations, will be performed within the required 
time windows 
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As guidance, where Holter resting periods coincide with other procedures i.e. vital signs 
and ECGs the order of procedures will be: 
Resting 
period 
 
ECGs 
 
Holter 
Extraction or 
ECG Machine 
 
Vitals  
 
PK blood 
sampling 
(nominal 
time) 
 
Other 
assessments 
e.g. physical 
examinations 
 
The Holter recording will be initiated before IMP dosing to allow for extraction of baseline 
ECGs. Then, before each PK time point, a rest period of approximately 15 min will be 
applied to ensure reasonable heart rate stability to allow extraction from the Holter 
recording or triplicate machine ECGs. 
All safety assessments will be timed and performed relative to the start of dosing. 
10.3.3 Discharge from the Clinical Unit 
A participant will be allowed to leave the premises without additional investigator or 
sub-investigator review, following completion of study-specific procedures at 96 h 
post-dose (Part 1)/post-final dose (Parts 2 and 3), providing that: 
• 
No AEs have been reported during the study visit  
• 
The participant responds in the affirmative when asked if they are feeling well 
If any of these conditions are not met, then the participant will only be allowed to leave 
the clinical unit with the authorisation of the investigator or sub-investigator. 
There will be no continued provision of the study intervention or treatment for participants 
as this study involves healthy volunteers only. 
10.3.4 Return Visits 
Participants will be required to return to the clinical unit on Day 7 in Part 1 for the 
assessments described in Appendix 2 and on Day 9 in Part 3 for the assessments 
described in Appendix 4. The acceptable deviations for the return visit PK, vital signs 
and ECG assessments are described in Sections 13.1.1, 14.6 and 14.7, respectively. 
10.3.5 End of Study Visits 
Participants will be required to return to the clinical unit for end of study assessments on 
Day 15 (± 1 day) in Part 1 (as described in Appendix 2), on Day 14 (± 1 day) in Part 2 
(as described in Appendix 3), and on Day 17 (± 1 day) in Part 3 (as described in 
Appendix 4). The acceptable deviations for the end of study visit PK, vital signs and ECG 
assessments are described in Sections 13.1.1, 14.6 and 14.7, respectively. 
10.3.6 Medical Supervision 
A physician will be responsible for the clinical aspects of the study and will be available 
at all times during the study. In accordance with the current Association of the British 
Pharmaceutical Industry guidelines [9], each participant will receive a card stating the 
telephone number of the investigator and the 24/7 contact details of the Quotient’s on-call 
physician. 
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10.3.7 Follow-up 
If a participant reports an SAE in the 30 days after the end of study visit, they may be 
required to attend the clinical unit for a further follow-up assessment (as an unscheduled 
visit). Completion of the last discharge assessment or unscheduled follow-up visit will be 
considered the end of the study. 
11 Dosing of Participants 
11.1 Food and Fluid Intake 
Participants will be allowed water up to 1 h before the scheduled dosing time and will be 
provided with 240 mL of water at 1 h post-dose (to ensure adequate hydration), and 
thereafter, water will be allowed ad libitum. Decaffeinated fluids will be allowed ad libitum 
from lunch time on the day of dosing. 
If, for technical reasons, dosing is delayed for more than 2 h beyond the expected dosing 
time, participants will receive 200 mL of an electrolyte drink (e.g. Lucozade Sport) at the 
originally scheduled dosing time, or earlier if possible. 
Fed Dosing: Part 2, Fed Period 
The calorie/fat content of breakfast will be controlled on the fed dosing day (refer to 
Appendix 8 for breakfast content). Participants will be provided with a standardised menu 
for all other meals.  
For the fed regimen, a standard high-fat breakfast will be given 30 min before dosing. 
Participants will be provided with a light snack the evening prior to dosing and will fast 
from all food and drink (except water) until the following morning, when they will be 
provided with a standard high-fat breakfast.  
The breakfast should be consumed over a maximum period of 25 min, with dosing 
occurring 30 min after the start of breakfast. Participants should be encouraged to eat 
their meal evenly over the 25 min period. It is acknowledged that some participants will 
take less time to eat, but dosing should still occur 30 min after the start of breakfast. 
Participants must consume at least 90% of the pre-dose breakfast in order to eligible for 
dosing. The start and stop time and percentage of the breakfast consumed must be 
recorded in the source.  
The acceptable deviation for the pre-dose meal from the nominal time point is: 
• 
Pre-dose meal will be provided within ± 5 min of the nominal time point  
Lunch will be provided at approximately 4 h post-dose, an evening meal at approximately 
10 h post-dose and an evening snack at approximately 14 h post-dose. On subsequent 
days, meals will be provided at appropriate times. 
Fasted Dosing (Parts 1 and 3 and Part 2, Fasted Period) 
The calorie/fat content of meals are not required to be controlled. Participants will be 
provided with a standardised menu.  
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Participants will be provided with a light snack the evening prior to dosing and then fast 
from all food and drink (except water) for a minimum of 8 h on the day prior to dosing 
until approximately 4 h post-dose, at which time lunch will be provided. An evening meal 
will be provided at approximately 10 h post-dose and an evening snack at approximately 
14 h post-dose. 
On subsequent non-dosing days, meals will be provided at appropriate times. 
11.2 Administration of Test Preparations 
Specific details of the IMP, and doses to be administered are provided in Section 5.2 and 
Section 8.1, respectively. In Parts 1 and 2, participants will be dosed on the morning of 
Day 1 of each study period, as applicable. In Part 3, participants will be dosed on the 
morning of Days 1, 2 and 3.  
The exact time of dosing will be decided based on logistics and will be documented in 
the source. If appearance matching of the placebo is not possible then masking and/or 
unblinded dosing teams will be used to preserve the study blind. Further details of these 
steps will be contained in the study specific blinding plan, which will be approved prior to 
dosing (see also Section 8.8.2). 
For Part 3, the acceptable deviation for dose administrations from the nominal time point 
is: 
• 
Days 2 and 3 dose will be administered within ± 30 min of the nominal dosing 
time point, relative to the dosing time on Day 1 
It is planned that each dose level (Parts 1 and 3) will be administered in a staggered 
‘sentinel’ dose design. All groups will be split into two subcohorts; in Cohort Xa, one 
participant will receive active IMP and one participant will receive placebo; in Cohort Xb, 
five participants will receive active IMP, and one participant will receive placebo, where 
X indicates the number of the cohort. 
Participants in Part 1 will receive a single dose of MMV367 or matching placebo. 
Participants in Part 2 will receive a single dose of MMV367 on 2 separate occasions: 1 in 
the fed state and 1 in the fasted state, in a crossover design. Participants in Part 3 will 
receive three doses of MMV367 or matching placebo QD over 3 consecutive days.  
The IMP will be dispersed in sterile water. Immediately after administration of the oral 
solution, the dosing vessel will be rinsed with water and participants will consume the 
rinse solution. During dosing, participants will consume up to a maximum total volume of 
500 mL (including the dosing volume and volume of water used to rinse the dosing 
vessel) depending on the dose level. If required, additional water may be given with the 
IMP in 50 mL aliquots and will be recorded in the source but will not be classed as a 
protocol deviation. 
In Part 1 only, each participant will test the taste and palatability of the IMP (single dose 
on Day 1). The IMP will be held in the mouth and swirled for 10 to 15 sec before 
swallowing. The participant will subsequently complete a written palatability 
questionnaire individually and privately. Participants will receive training on admission 
(see Section 8.1.1) before the palatability test/dosing. Participants will be allowed to 
cleanse their palates using tap water (administered freely in 50 to 100 mL aliquots) 
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before tasting the IMP. During the taste test, participants will be observed by study staff 
to assure compliance.   
11.3 Dosing Compliance 
During all clinical phases of the study, participants will be observed by study staff to 
assure compliance to all study procedures, including dose administration.  
Mouth checks will be conducted after dosing to ensure the solution has been swallowed. 
The date and time that each participant is dosed will be recorded in the participant’s 
source data. Any violation of compliance will require evaluation by the investigator and 
sponsor to determine if the participant can continue in the study. 
11.4 Prior and Concomitant Medications 
No prescribed, over-the-counter medication or herbal remedies will be permitted from 
14 days before IMP administration until after the end of study visit, except up to 4 g of 
paracetamol per day, hormonal contraception and HRT and those deemed necessary 
by the investigator to treat AEs (see also Section 9.3). Any medications used will be 
recorded in the source. 
COVID-19 vaccines are not accepted concomitant medications. Participants will be 
excluded if they have received the vaccine within 7 days prior to first administration of 
IMP so that by the time of dosing any effects of the vaccine (e.g. pyrexia, fatigue, 
pain/stiffness at site of injection) are likely to have abated, and vaccines will be prohibited 
until discharge from the study. 
Emergency equipment and drugs will be available within the clinical unit as per current 
standard procedures. In the unlikely event that they are required, their use will be 
documented. 
12 Assessment of Efficacy 
Not applicable for this Phase I study.  
13 Assessment of Pharmacokinetics, Metabolite Identification 
and Pharmacodynamics 
13.1 Assessment of Pharmacokinetics and Metabolite Identification 
13.1.1 Blood Sampling for Pharmacokinetics and Metabolite Identification 
Venous blood samples will be collected from the participants by a trained member of the 
clinical team. Consent will be collected from the participants for use of these samples for 
the purposes of the proposed study. Samples will be processed to isolate plasma and 
PK analysis and metabolite identification, where appropriate, will be carried out on 
plasma samples. 
Plasma samples will be sent for laboratory testing in linked anonymised form (participant 
number only). This information is able to be linked directly to the volunteer by the 
Quotient research team and study monitor, however not by the laboratory staff or 
sponsor. 
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Venous blood samples will be withdrawn via an indwelling cannula or by venepuncture 
according to the time schedules presented in Appendix 5, Appendix 6 and Appendix 7. 
All PK windows will be timed relative to the start of dosing and actual sampling times will 
be recorded. 
The acceptable deviations from the nominal blood sampling times are as follows: 
• 
Day 1 in all parts and Day 8 in Part 2: The pre-dose samples will be taken ≤15 min 
before dosing 
• 
On Days 2 and 3 (Part 3 only): The 24 h time point will coincide with the pre-dose 
sample; samples will be taken ≤10 min of the nominal time point 
• 
0 to 1 h post-dose samples will be taken within ± 2 min of the nominal post-dose 
sampling time  
• 
2 to 12 h post-dose samples will be taken within ± 10 min of the nominal post-dose 
sampling time 
• 
24 to 96 h post-dose samples will be taken within ± 30 min of the nominal post-dose 
sampling time if participants are resident in the clinical unit 
• 
≥144 h post-dose samples will be taken within ± 2 h of the nominal post-dose 
sampling time if participants are attending a return visit 
• 
On Day 14 (Part 2 only): The End of Study sample will be taken within ± 1 day of the 
nominal post-dose sampling time point 
The timing and number of the samples may be amended following any interim PK 
parameter estimations, including collection over a longer duration. Any changes to blood 
sampling time points would be documented in the interim dose decision report and 
retained in the ISF. 
Samples will be collected into appropriate tubes as specified by the bioanalytical 
laboratory. Details of sample tubes and processing will be contained in the 
Clinical Sample Processing Manual (CSPM). 
Samples will be shipped to Swiss BioQuant for the analysis of MMV367 and, where 
appropriate, metabolite(s). 
13.1.2 Urine Sampling for Pharmacokinetics and Metabolite Identification 
Urine samples will be collected in Part 1, Cohorts 1C and 1D, according to the time 
schedule presented in Appendix 5, provided a future bioanalytical method will be 
available. 
The pre-dose urine sample will be taken in the 24 h period before dosing. Where a 
sample is not provided, this will not be considered a deviation. All individual urine voids 
will be collected and shipped to the bioanalytical laboratory for analysis, according to 
Quotient’s SOPs, unless indicated otherwise by the sponsor. 
Consent will be collected from the participants for use of these samples for the purposes 
of the proposed study. Samples will be collected into appropriate containers as specified 
by the bioanalytical laboratory. Details of sample containers and processing will be 
contained in the CSPM. 
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Urine samples will be sent for laboratory testing in linked anonymised form (participant 
number). This information is able to be linked directly to the volunteer by the Quotient 
research team and study monitor; however, not by the laboratory staff or sponsor. 
Samples will be shipped to Swiss BioQuant for the analysis of MMV367 and 
metabolite(s). 
13.2 Assessment of Pharmacodynamics 
Not applicable for this Phase I study. 
13.3 Taste/Palatability Evaluation 
Taste/Palatability will be assessed in Part 1 using a questionnaire (example provided in 
Appendix 9) at the time points detailed in Appendix 2. The questionnaire will ask 
participants to rate the overall acceptability of taste/palatability, with additional questions 
asked on specific palatability attributes (smell, sweetness, bitterness, flavour, mouth 
feel/texture, grittiness, and aftertaste), on a 9-point Likert scale. The clinical staff will 
provide definitions and examples of each aspect that is being rated if required. 
Each participant in Part 1 of the study will complete the questionnaire individually and 
privately, within no more than 10 min, following IMP administration. 
14 Assessment of Safety 
14.1 Definition and Classification of Adverse Events 
An AE is any untoward medical occurrence in a participant that occurs either before 
dosing (referred to as a pre-dose AE) or once a medicinal product has been 
administered, including occurrences which are not necessarily caused by or related to 
that product.  
An adverse drug reaction is any AE where a causal relationship with the IMP is at least 
a reasonable possibility (related). 
AEs will be monitored from the time the participant signs the ICF until the end of study 
visit. The severity of AEs should be assessed as follows: 
Mild 
An AE that is easily tolerated by the participant, causes minimal discomfort 
and does not interfere with everyday activities 
Moderate An AE that is sufficiently discomforting to interfere with normal everyday 
activities; intervention may be needed 
Severe 
An AE that prevents normal everyday activities; treatment or other 
intervention usually needed 
14.2 Assessment of Assessment of Causality 
Every effort should be made by the investigator to try to explain each AE and assess its 
relationship, if any, to the IMP. The temporal relationship of the event to IMP 
administration should be considered in the causality assessment (i.e. if the event starts 
soon after IMP administration and resolves when the IMP is stopped). 
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Causality should be assessed using the following categories: 
Unrelated: 
An AE which cannot be reasonably explained by available facts (evidence) or arguments 
that the study drug caused the AE. For example, the occurrence of the AE can be 
explained by other causative factors, such as: 
• 
Event attributed to concomitant medication. 
• 
No reasonably temporal relationship associated with IMP administration  
• 
Event is expected in the study indication and/or target population 
• 
Negative de-challenge and/or negative re-challenge 
• 
Other (must be specified) 
Related: 
An AE for which it can be reasonably explained that the study drug caused the AE by 
available facts (evidence) or arguments. For example, the occurrence of the AE cannot 
be explained by other causative factors, but can be explained by pharmacological effect 
of the study drug such as: 
• 
Temporal relationship to IMP exposure 
• 
Event is known to be associated with the IMP drug class 
• 
Event improved on discontinuation or dose reduction of IMP 
• 
Biological plausibility 
• 
Other (must be specified on the source documents) 
 
The degree of certainty with which an AE is attributed to IMP administration (or 
alternative causes, e.g. natural history of the underlying disease, concomitant therapy) 
will be determined by how well the experience can be understood in terms of one or more 
of the following: 
• 
Known pharmacology of the IMP 
• 
Reactions of a similar nature have been previously observed with the IMP or this 
class of drug 
• 
The experience being related by time to IMP administration, terminating with IMP 
withdrawal or recurring on re-challenge 
• 
Alternative cause 
14.3 Recording Adverse Events 
AEs (including SAEs) will be recorded from the time of providing written informed consent 
until the end of study visit or unscheduled follow-up visit. During each study visit the 
participant will be questioned directly regarding the occurrence of any adverse medical 
event according to the schedule in the source. All AEs, whether ascribed to study 
procedures or not, will be documented immediately in the participant’s source. This will 
include the date and time of onset, a description of the AE, severity, seriousness, 
duration, actions taken, outcome and an investigator’s current opinion on the relationship 
between the study drug and the event. A diagnosis and final opinion on the relationship 
between the study drug and the event will be provided at the end of the study by the 
investigator.  
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Any participant who withdraws from the study due to an AE will be followed up until the 
outcome is determined and written reports are provided by the investigator. 
14.4 Serious Adverse Events 
14.4.1 Definition of Serious Adverse Events 
A serious adverse event (SAE) is defined as any untoward medical occurrence that at 
any dose:  
• 
Results in death 
• 
Is life-threatening 
• 
Requires hospitalisation or prolongation of existing hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Consists of a congenital anomaly or birth defect 
• 
An important medical event as recognised by the investigator 
SAEs must be immediately reported to the sponsor. 
Spontaneously reported SAEs will be collected until 30 days following the final study 
visit. SAEs experienced after this 30-day period will only be reported if the investigator 
suspects a causal relationship with the study drug. 
14.4.2 Definition of Suspected Unexpected Serious Adverse Reactions 
Suspected unexpected serious adverse reactions (SUSARs) are AEs that are believed 
to be related to an IMP and are both unexpected (i.e. the nature or severity is not 
expected from the information provided in the IB) and serious. SUSARs are subject to 
expedited reporting to the MHRA and EC (see Section 16.3.2 for details on reporting 
SUSARs). 
14.4.3 Expectedness (Reference Safety Information) 
The Reference Safety Information is used for the assessment of the expectedness of all 
‘suspected’ serious adverse reactions (SARs) that occur in clinical trials. The 
expectedness of a SAR is determined by the sponsor. The list of ‘expected SARs’ should 
be based on ‘suspected’ SARs that were previously observed and not on the basis of 
what might be anticipated from the pharmacological properties of a medicinal product or 
the compound class. An ‘expected’ SAR is therefore one that is listed in the Reference 
Safety Information. An adverse reaction, the nature of which is not consistent with the 
applicable reference safety information (in the IB for drugs in clinical development or 
SmPC for marketed drugs) is unexpected. Reports which add significant information on 
the specificity, increase in the occurrence or severity of a known and already 
documented SAR are unexpected events. 
14.5 Laboratory Measurements 
Venous blood and urine samples will be collected from the participants by a trained 
member of the clinical team. Consent will be collected from the participants for use of 
these samples for the purposes of the proposed study. 
Blood and urine samples are sent for laboratory testing in linked anonymised form 
(participant number, gender and date of birth for analytical reasons). This information is 
able to be linked directly to the volunteer by the Quotient research team and study 
monitor; however, not by the laboratory staff or sponsor. 
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Safety laboratory tests and virology will be carried out on blood samples, and drugs of 
abuse tests and urinalysis will be carried out on urine samples. Blood samples will be 
collected for DNA analysis, as detailed in Section 14.5.9. 
Blood and urine samples results will be reviewed by a physician and acted upon before 
the participant is dosed or receives their next dose, or is released from the study, as is 
appropriate. A list of the laboratory parameters measured is presented in Appendix 1. 
14.5.1 Haematology, Clinical Chemistry and Coagulation 
Laboratory tests will be performed by The Doctors Laboratory according to the time 
schedules presented in Appendix 5, Appendix 6 and Appendix 7. Blood samples will be 
collected and processed as detailed in the CSPM. Scheduled blood samples will be 
taken following an 8 h fast. 
The acceptable deviations from the nominal blood sampling time points for laboratory 
assessments are: 
• 
Post-dose/post-first dose blood samples will be taken ± 1 h from the nominal blood 
sampling time 
• 
End of Study blood samples will be taken ± 1 day from the nominal blood sampling 
time 
Creatinine clearance (CLcr) will be calculated at admission by The Doctors Laboratory 
using the Cockcroft-Gault equation [10] and body weight. Results of this assessment will 
be used for PK analysis and PK-PD modelling (reported separately). 
14.5.2 Urinalysis 
Urinalysis will be performed on-site using a dipstick according to the time schedules 
presented in Appendix 2, Appendix 3 and Appendix 4.  
Urine samples will be collected and processed as detailed in the CSPM.  
In Part 1, any urine used for urinalysis will be added back to the full sample for PK and 
metabolite identification analysis. If microscopy is required, a urine sample 
(approximately 20 mL) will be taken from the urine PK and metabolite collection, and 
sent to The Doctor’s Laboratory, after the void has been weighed. 
In Parts 2 and 3, if microscopy is required, a urine sample will be sent to The Doctor’s 
Laboratory. 
The acceptable deviations from the nominal urine sampling time points for urinalysis are: 
• 
On Day 3 (Part 3 only): the pre-dose urine sample will be taken ≤1 h before dosing.  
• 
Post-dose urine samples will be taken ± 2 h from the nominal urine sampling time 
• 
End of Study urine samples will be taken ± 1 day from the nominal urine sampling 
time 
14.5.3 Pregnancy Test 
Serum and urine highly sensitive pregnancy tests will be performed as detailed in 
Appendix 2, Appendix 3 and Appendix 4. The samples will be collected and processed 
as detailed in the CSPM.  
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14.5.4 Follicle-Stimulating Hormone Test 
Serum FSH tests will be performed as detailed in Appendix 2, Appendix 3 and 
Appendix 4. The samples will be collected and processed as detailed in the CSPM. 
14.5.5 Drug Screen 
A urine drug screen will be performed on-site using a point of care testing method 
(e.g. Alere Drug Screen Test Cup) according to the time schedules presented in 
Appendix 2, Appendix 3 and Appendix 4. The sample will be collected and processed as 
detailed in the CSPM. Participants will be screened for the drugs of abuse listed in 
Appendix 1.  
14.5.6 Alcohol Breath Test 
An alcohol breath test will be performed according to the time schedules presented in 
Appendix 2, Appendix 3 and Appendix 4. A positive result will exclude the participant 
from dosing. 
14.5.7 Carbon Monoxide Breath Test 
A carbon monoxide breath test will be performed according to the time schedules 
presented in Appendix 2, Appendix 3 and Appendix 4. A result of greater than 10 ppm 
will exclude the participant from the study. 
14.5.8 SARS-CoV-2 Tests 
Testing for the SARS-CoV-2 virus will be performed at screening and admission and may 
be performed at other time points, if required, based on current infection rates and 
availability of tests. Tests will be performed according to the time schedules presented 
in Appendix 2, Appendix 3 and Appendix 4. The samples will be collected and processed 
as detailed in the Screening Sample Processing Manual and CSPM. 
Testing time points may be changed and additional time points may be added throughout 
the study as required. The decision on COVID-19 testing and the definition of the testing 
time points are subject to change based on the current risk mitigation in place and will 
be agreed by the study team and documented in the ISF via the Clinical Kick-Off Meeting 
minutes. 
14.5.9 Genetic Samples 
In Part 1, Part 2 (Period 1 only) and Part 3, one mandatory blood sample per participant 
will be collected on Day 1 prior to IMP administration (≤2 h before dosing) to investigate 
allelic variants related to drug metabolism cytochrome P450 (CYP) enzymes and drug 
transporters that are potentially involved in the MMV367 absorption, distribution, 
metabolism and excretion. The blood sample and the extracted DNA will be kept until 
the end of study and will only be analysed under specific circumstances, including 
abnormal or unexpected PK or safety results. The decision to conduct the analysis will 
be taken once all data is available after last participant visit. The blood sample and 
extracted DNA will be destroyed either upon completion of analysis or when it is 
confirmed that they will not be required for analysis. 
The sample will be collected and processed as detailed in the CSPM. 
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14.5.10 
Abnormal Laboratory Findings 
In cases where laboratory findings are outside the normal range and the investigator 
believes that the results may be of clinical significance, repeat sampling may be 
requested as clinically indicated. If the abnormal finding is clinically significant, 
appropriate actions will be taken e.g. the participant will not be entered into the study or 
the participant may be withdrawn from the study. The participant will be referred to their 
general practitioner or other appropriate provider for further care if necessary. The same 
will apply if the results of the HBsAg, HCV Ab or HIV test are positive and in addition the 
investigator will ensure that adequate counselling is available if requested. 
Abnormal results at any unscheduled follow-up assessments will also require repeat 
testing if the investigator believes the results may be of clinical significance. 
Any clinically significant abnormality, including changes from baseline, must be reported 
as an AE. 
Additional blood and/or urine samples may be taken for safety tests. Furthermore, 
additional assays outside those specified in the protocol may be performed for safety 
reasons as requested by the investigator or sub-investigator. 
14.6 Vital Signs Measurements 
Blood pressure and heart rate will be measured by an automated recorder after the 
participant has been in a supine position for a minimum of 5 min and oral temperature 
and respiratory rate will be measured according to the time schedules presented in 
Appendix 2Appendix 5, Appendix 6 and Appendix 7.  
Blood pressure and heart rate orthostatic measurements will also be taken according to 
the time schedules presented in Appendix 5, Appendix 6 and Appendix 7. Two 
measurements will be recorded; 1 supine and 1 standing. The first supine measurement 
will be performed after the participant has rested in a supine position for at least 5 min. 
The second blood pressure and heart rate measurements will be performed after the 
participant has been standing for at least 3 min but no more than 5 min. Orthostatic 
hypotension will be defined as either: 
• 
A decrease of SBP ≥ 20 mmHg after 3 min standing, or 
• 
A decrease of DBP ≥ 10 mmHg after 3min standing 
The acceptable deviations from the nominal vital signs measurement time points are: 
• 
Day 1 in all parts and Day 8 in Part 2: The pre-dose vital signs measurements will be 
taken ≤2 h before dosing 
• 
On Days 2 and 3 (Part 3 only): the pre-dose vital signs measurements will be taken 
≤1 h before dosing.  
• 
Post-dose vital signs measurements will be taken ± 15 min from the nominal 
post-dose time point. 
• 
For return visits, vital signs measurements will be taken ± 2 h from the nominal return 
visit time point. 
• 
End of study visit vital signs measurements will be taken ± 1 day from the nominal 
time point. 
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If a participant shows an abnormal assessment at any stage, repeat measurements may 
be made and the abnormality followed to resolution if required. Additional measurements 
may be taken as deemed necessary by the investigator or sub-investigator.  
Any clinically significant abnormality, including changes from baseline, must be reported 
as an AE. 
14.7 ECG Measurements 
Single 12-lead ECGs will be measured after the participant has been in the supine 
position for a minimum of 5 min according to the time schedules presented in Appendix 5, 
Appendix 6 and Appendix 7. 
Triplicate 12-lead ECG measurements will be performed at least 2 min and no longer 
than 4 min apart after the participant has been in the supine position with no external 
stimuli (e.g. music or television) for 15 min prior to the nominal time point where a 
triplicate ECG is scheduled (Appendix 5, Appendix 6 and Appendix 7). No other 
procedures should be performed within the 15 min resting period. 
The acceptable deviations from the nominal ECG measurement time points are: 
• 
Post-dose triplicate ECG resting periods will be ended within ± 15 min of the nominal 
time point 
• 
Day 1 only: The pre-dose ECG measurements will be taken ≤2 h before dosing 
• 
On Days 2 and 3 (Part 3 only): the pre-dose ECG measurements will be taken ≤1 h 
before dosing.  
• 
Post-dose ECG measurements will be taken ± 15 min from the nominal post-dose 
time point. 
• 
For return visits, ECG measurements will be taken ± 2 h from the nominal return visit 
time point.  
• 
End of study ECG measurements will be taken ± 1 day from the nominal time point.  
The ECGs will be collected electronically and over-read by cardiologists at Banook. The 
Banook over-read will be used for cardiac safety evaluations during SAC data review. 
For safety assessments, a mean value for the triplicate ECGs will be reviewed. 
If a participant shows an abnormal assessment at any stage, repeat measurements may 
be made and the abnormality followed to resolution if required. Additional measurements 
may be taken as deemed necessary by the investigator or sub-investigator. 
Any clinically significant abnormality, including changes from baseline, will be reported 
as an AE. 
14.8 Holter (continuous ECG) Monitoring 
All ECGs will be collected electronically using a Mortara H12+ Holter Recorder, and 
analysed by Banook. Specific procedures for ECG Holter recording and extractions will 
be provided to the investigator by Banook.  
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According to the time schedules presented in Appendix 5, Appendix 6 and Appendix 7, 
continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 
24 h post-dose. Participants will be required to rest in the supine position with no external 
stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG 
extraction is scheduled. This extraction will be taken by the third party Holter provider at 
the planned time and therefore no other procedures should be performed within the 
resting period. 
Where one period of ECG rest runs into the rest period for the next ECG extraction, the 
minimum resting period before ECG extraction does not need to be started again except 
in cases where the rest is disturbed (e.g. participants has to get up for a comfort break 
after the preceding rest period).  
Participants may move more freely outside of the primary ECG rest periods. Comfort 
breaks for hygienic purposes will be allowed each morning well in advance of the 
required supine/ECG extraction points. 
Where any scheduled rest times are missed, where there is less than a 10 min rest period 
or where the final 5 min of a rest period is interrupted (for example, by participant 
movement or loss of leads) a protocol deviation will be recorded and the Holter provider 
informed.  
Loss of leads or interruption of the recording outside of the scheduled rest times will not 
be considered a protocol deviation but should be recorded in the source. 
The acceptable deviations for ECG rest periods from the nominal time point are: 
• 
Pre-dose and post-dose ECG resting periods will be ended within ± 15 min of the 
nominal time point 
See Section 10.3.2 for details on timing of Holter rest period/extractions in relation to 
other procedures and Appendix 7 for rest period/extraction time points.  
The ECGs will be collected electronically and over-read by cardiologists at Banook. The 
Banook over-read will be used for cardiac safety evaluations during SAC data review. 
14.9 Telemetry (Continuous ECG) 
On Day 1 of Parts 1 and 2, telemetry (continuous ECG monitoring) will commence at 
least 30 min before dosing until at least 12 h post-dose. As this monitoring is for safety 
purposes alone no data will be recorded in the source, except the start and stop time. If 
cardiac monitoring shows a potentially significant abnormality, a clinical assessment of 
the participant including a 12-lead ECG will be performed and treatment given, if 
appropriate. 
14.10 Body Weight, Height and BMI 
The participant’s body weight and height will be measured and their BMI will be 
calculated according to the time schedules presented in Appendix 2, Appendix 3 and 
Appendix 4. 
14.11 Physical Examination 
Participants will undergo a physical examination according to the time schedules 
presented in Appendix 2, Appendix 3 and Appendix 4. 
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In the targeted (symptom driven) physical examination, a physician will assess the 
participant; if the participant reports feeling unwell or has ongoing AEs, then the 
physician will examine the appropriate body system(s) if required. 
14.12 Beck Depression Inventory (BDI-II) Questionnaire   
Each participant will undergo a BDI-II questionnaire [7], according to the time schedules 
presented in Appendix 2, Appendix 3 and Appendix 4. A participant will be excluded from 
the trial if they have a score of 20 or more on the BDI-II, and/or a response of 1, 2 or 3 
for item 9 of this inventory (related to suicidal ideation). 
Individuals with a BDI-II score of 17-19 may be enrolled, at the discretion of the 
investigator, if they do not have a medical history of psychiatric conditions and their 
mental state is not considered to pose additional risk to the health of the individual or to 
the execution of the trial and interpretation of the data. 
14.13 Additional Safety Procedures 
Additional non-invasive procedures that are already specified in the protocol may be 
performed, if it is believed that an important effect of the IMP(s) is occurring or may occur 
at a time when no measurements are scheduled, or if extra procedures are needed in 
the interests of safety. 
Additional blood samples for safety assessments may be taken if required by the 
investigator or sub-investigator at any point. 
15 Statistics and Data Analysis 
15.1 Sample Size Justification 
For Parts 1 and 3, the primary objective is an initial assessment of safety and each 
treatment group is therefore limited to 6 participants receiving active IMP. Administration 
of MMV367 to 6 participants at each dose level provides a 47%, 62%, 74%, or 82% 
probability of observing at least 1 occurrence of any AE, with a true incidence rate for a 
given dose group of 10%, 15%, 20%, or 25%, respectively. 
Furthermore, it is assumed that pooling the data for the 2 participants who receive 
placebo in each cohort will provide an adequately sized control group to assess a 
possible drug effect on safety laboratory tests, vitals and ECG parameters. 
Part 2 is a pilot evaluation designed to determine whether MMV367 PK is impacted by 
high-fat food. Historically, 8 participants have proven sufficient to characterise the 
preliminary effects of food on safety and PK of a new chemical entity in healthy 
participants. Therefore, a sample size of 8 is considered adequate at this stage of drug 
development. 
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15.2 Data Management 
Data management will be performed by Quotient. 
Study data will be managed using a validated electronic case report form (eCRF) 
database system and will be subjected to data consistency and validation checks. Data 
queries will be raised within the study eCRF database by data management staff and 
resolved with the assistance of clinical staff. 
AEs, medical histories and medications will be coded using the Medical Dictionary for 
Regulatory Activities (version to be specified in the Data Management Plan [DMP]) and 
the World Health Organization Drug Dictionary Global Drug Reference (version to be 
specified in the DPM), respectively. An independent coding review will also be performed 
within the Data Sciences department. 
Clinical chemistry, haematology and coagulation data (and other safety laboratory data) 
will be collected by a central laboratory (The Doctors Laboratory) and stored 
electronically in their clinical pathology system. The data will be transferred electronically 
to Quotient and all demographic details and sample dates will be cross-referenced with 
the corresponding data on the study database. All queries will be resolved with the 
assistance of laboratory staff, or if necessary, clinical staff.  
The database will be closed after all queries have been resolved. The database will be 
locked when all criteria listed in the DMP are met.  
Further details are addressed in the DMP. 
15.3 Pharmacokinetic Data Analysis 
The plasma concentration data for MMV367 provided by Swiss BioQuant will be 
analysed by Quotient, using Phoenix WinNonlin v8.3 or a more recent version (Certara 
USA, Inc., USA). 
PK analysis of the concentration time data obtained will be performed using appropriate 
non-compartmental techniques to obtain estimates of the PK parameters presented in 
Table 7 and Table 8, where possible and appropriate. 
Table 7 
Plasma Pharmacokinetic Parameters: Part 1 and 2 
Parameter 
Definition 
Tmax 
Time of maximum observed concentration 
Cmax 
Maximum observed concentration 
AUC(0-24) 
Area under the curve from time 0 to 24 h post-dose 
AUC(0-48) 
Area under the curve from time 0 to 48 h post-dose 
AUC(0-last) 
Area under the curve from time 0 to the time of last measurable concentration 
AUC(0-inf) 
Area under the curve from time 0 extrapolated to infinity 
T1/2  
Terminal elimination half-life 
CL/F 
Total body clearance calculated after a single extravascular administration where 
F (fraction of dose bioavailable) is unknown 
Vz/F 
Apparent volume of distribution based on the terminal phase calculated using 
AUC(0-inf) after a single extravascular administration where F (fraction of dose 
bioavailable) is unknown 
Frel Cmax 
Relative bioavailability based on Cmax (Part 2 fed dosing only) 
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Parameter 
Definition 
Frel AUC(0-last) 
Relative bioavailability based on AUC(0-last) (Part 2 fed dosing only) 
Frel AUC(0-inf) 
Relative bioavailability based on AUC(0-inf) (Part 2 fed dosing only) 
Table 8 
Plasma Pharmacokinetic Parameters: Part 3 
Parameter 
Definition 
Tmax 
Time of maximum observed concentration 
Cmax 
Maximum observed concentration 
AUC(0-tau) 
Area under the curve for the defined interval between doses (tau) 
T1/2  
Terminal elimination half-life (Day 3 only) 
CL/Ftau 
Total body clearance calculated using AUC(0-tau) after repeated extravascular 
administration where F (fraction of dose bioavailable) is unknown (Day 3 only) 
Vz/Ftau 
Apparent volume of distribution based on the terminal phase calculated using AUC(0-
tau) after repeated extravascular administration where F (fraction of dose 
bioavailable) is unknown (Day 3 only) 
AR Cmax 
Accumulation ratio based on Cmax repeated dose/Cmax single dose (Day 3 only) 
AR AUC 
Accumulation ratio based on AUC(0 tau) repeated dose/AUC(0 tau) single dose 
(Day 3 only)  
Analysis of drug related QT/QTc interval changes relative to plasma PK concentrations 
will be conducted. This analysis will be performed on the analysis set for intensive cardiac 
assessment. Concentration/QTc modelling may be performed after completion of the 
CSR and will be reported separately. 
In Part 1 Cohorts 1C and 1D, provided a future bioanalytical method is available, urine 
concentration data for MMV367, provided by Swiss BioQuant, will be analysed by 
Quotient and reported in an addendum to the CSR or in a separate report. Estimates of 
the parameters presented in Table 9 in urine will be obtained where possible and 
appropriate. 
Table 9 
Urine Pharmacokinetic Parameters: Part 1, Cohorts 1C and 1D only 
Parameter 
Definition 
CLr 
Renal clearance calculated using plasma AUC 
Ae 
Amount excreted 
CumAe 
Cumulative amount excreted 
%Ae 
Percentage of dose excreted  
Cum%Ae 
Cumulative percentage of dose excreted  
Interim PK parameter estimations will be provided as described in Section 8.2. 
Further details of the PK data analysis will be included in the reporting and analysis plan 
(RAP). 
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15.4 Metabolite Profiling and Identification Assessment 
Metabolite profiling of MMV367 in plasma and urine will be performed using existing PK 
samples (pooled residual samples) collected in Part 1. Potential metabolites will be 
identified using liquid chromatography-mass spectrometry analysis. If results suggest 
that a major metabolite is present in plasma (e.g. greater than 10% of circulating 
MMV367 in plasma based on peak AUCs), metabolite quantification and PK analysis in 
plasma will be performed provided a future bioanalytical method is available. These 
results may be reported in an addendum to the CSR or in a separate report. 
15.5 Statistical Data Analysis  
Statistical analysis and production of summary tables, figures and listings for this study 
will be performed by Quotient using the statistical package SAS (v9.4 or more recent 
version).  
In general terms, categorical data (including treatment-emergent AEs) will be presented 
using counts and percentages, while continuous variables will be presented using the 
mean, median, standard deviation, minimum and maximum. Additional statistics will be 
provided for PK-related data including coefficient of variation (CV%), geometric mean 
and geometric CV%.  
Descriptive summaries for all safety data (AEs, vital signs, ECGs and safety laboratory 
assessments) by regimen will be provided (including changes from baseline as required). 
Descriptive summaries for all PK data by regimen will be provided.  
All safety and PK data will be listed. 
Assessment of Dose Proportionality  
For Part 1, dose proportionality will be assessed using a power model approach using 
log-transformed Cmax, AUC(0-last) and AUC(0-inf) values, including data from up to 
5 different dose levels, i.e., general linear model including log dose as a fixed effect and 
log PK parameter as the dependent variable. The estimate obtained for β together with 
its 90% confidence interval (CI) will be presented along with the number of participants 
and the geometric means. The resulting estimate slope (β) and 90% CI is a measure of 
dose proportionality; the relationship is considered dose proportional when β = 1. 
Assessment of Taste Questionnaire Data  
In Part 1, formal statistical analysis will be performed on the scores of each taste attribute 
and overall acceptability, in the comparison of each dose level of MMV367 to the pooled 
placebos, using non-parametric methods. Hodges-Lehmann estimation methods will be 
used to estimate the median difference between each dose level and the pooled 
placebos. The associated 95% CI will be calculated for the estimate. The p-value will be 
calculated from the Wilcoxon Rank Sum Test (Mann-Whitney-Wilcoxon Test) for the test 
of the null hypothesis that the difference between the medians of each dose level and 
the pooled placebos is equal to zero, with the alternative hypothesis being that the 
difference is not equal to zero.  
The number of participants and the median score for each treatment will be presented 
together with the Hodges-Lehmann estimate of the median difference and associated 
90% CI. In addition, the p-value from the Wilcoxon Rank Sum Test will also be presented. 
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Assessment of Food Effect 
In addition, for Part 2, formal statistical analysis will be performed, at a minimum, on the 
following PK parameters: Cmax, AUC(0-last) and AUC(0-inf), to assess for the effects of 
food. The PK parameters will undergo a natural logarithmic transformation and will be 
analysed using a mixed effect model with terms for fed/fasted status and period fitted as 
fixed effects and participant fitted as a random effect. The adjusted mean difference 
between the fed and fasted states, and the associated 90% CI obtained from the model 
are back transformed on the log scale to obtain the adjusted geometric mean ratio and 
90% CI of the ratio. These will be presented together with the p-value from the fed/fasted 
comparison. 
A categorical analysis of QTcF data will be reported (Table 10). 
Table 10 
QTcF Categorical Analysis 
Absolute QTcF prolongation 
• 
QTcF >450 msec 
• 
QTcF >480 msec 
• 
QTcF >500 msec 
Change from baseline in QTcF 
• 
QTcF increases from baseline >30 msec 
• 
QTcF increases from baseline >60 msec 
Populations and analysis sets will be determined for safety, PK and taste data after 
database lock using the criteria defined in the RAP; the RAP will be signed off prior to 
database lock. 
The safety population and safety analysis set will be defined after database lock but prior 
to study unblinding; all other populations and analysis sets will be defined after database 
lock and unblinding when the relevant data are available. 
Further details relating to the statistical analysis will be included in the RAP including the 
following: 
• 
Criteria to be used to define each of the population and analysis sets 
• 
Additional detail covering the analyses and/or description of primary and secondary 
analyses and safety data 
• 
Handling of missing data, unused or spurious data 
• 
Handling of data from withdrawn participants 
• 
Unblinding procedures and maintaining the blind 
15.6 Interim Analysis 
No formal interim analyses are planned for this study. Interim Data Reviews will be 
performed as detailed in Section 8.2. 
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16 Safety Reporting to Regulatory Authorities and Ethics 
Committees 
16.1 Events Requiring Expedited Reporting 
SUSARs (Section 14.4.2) are subject to expedited reporting to the appropriate regulatory 
authority and EC. 
In addition to SUSARs, other safety issues may qualify for expedited reporting where 
they might materially alter the current benefit-risk assessment of an IMP or that would 
be sufficient to consider changes in the IMPs’ administration or in the overall conduct of 
the study, for instance: 
• 
An increase in the rate of occurrence or a qualitative change of an expected serious 
adverse reaction, which is judged to be clinically important 
• 
SAEs that occur after the participant has completed the clinical study where the 
sponsor considers them to be a SUSAR 
• 
New events related to the conduct of the study or the development of the IMPs and 
likely to affect the safety of the participants, such as: 
− An SAE which could be associated with the study procedures and which 
could modify the conduct of the study 
− A major safety finding from a newly completed animal study (such as 
carcinogenicity) 
− Any anticipated end or temporary halt of a study for safety reasons and 
conducted with the same IMPs in another country by the same sponsor 
16.2 Urgent Safety Measures 
If Quotient or any of its staff or contractors becomes aware of an actual or potential 
urgent safety issue, then the sponsor must be immediately contacted so that appropriate 
urgent safety measures can be agreed. An urgent safety issue is defined as:  
• 
An immediate hazard to the health or safety of participants participating in a clinical 
study 
• 
A serious risk to human health or potentially a serious risk to human health 
An urgent safety issue may include issues with an investigational drug or comparators, 
study procedures, inter-current illness (including pandemic infections), concomitant 
medications, concurrent medical conditions or any other issues related to the safe 
conduct of the study or that pose a risk to study participants. 
In exceptional circumstances of imminent hazard and in order to safeguard the health or 
safety of individuals, Quotient may take urgent safety measures before informing the 
sponsor, but the sponsor must be informed immediately after the hazard has resolved.  
The sponsor is responsible for informing the appropriate regulatory authorities, and the 
EC; the task of reporting urgent safety measures will be delegated to Quotient. 
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16.3 Reporting 
16.3.1 Reporting Serious Adverse Events 
The investigator is required to notify the study sponsor and pharmacovigilance provider 
within 24 h of becoming aware of the occurrence of an SAE or serious adverse reaction. 
A copy of the written report of the event should promptly be sent to the study sponsor for 
information purposes, in accordance with ICH guidelines for GCP [11]. 
16.3.2 Reporting of Suspected Unexpected Serious Adverse Reactions 
It is the responsibility of the sponsor to determine whether a reported SAE fits the 
classification of a SUSAR and to notify the investigator of their decision as soon as 
possible. 
16.3.3 Expedited Reporting of Events 
It is the responsibility of the sponsor to determine whether an event requires expedited 
reporting and to notify the investigator of their decision as soon as possible. 
Where expedited reporting is required, the following procedures should be followed. 
Fatal or life-threatening SUSARs 
It is the responsibility of the sponsor to report fatal or life-threatening SUSARs to the 
MHRA as soon as possible, but no later than 7 calendar days after they first became 
aware of the reaction. Any additional relevant information should be sent within 8 days 
of the report. The task of reporting fatal or life-threatening SUSARs may be delegated to 
the pharmacovigilance provider.  
The sponsor is required to notify the EC of any fatal or life-threatening SUSAR as soon 
as possible, but no later than 7 calendar days after they first became aware of the 
reaction. Any additional relevant information should be sent within 8 days of the report. 
The task of reporting fatal or life-threatening SUSARs may be delegated to the 
investigator. 
Other SUSARs 
It is the responsibility of the sponsor to report other SUSARs to the MHRA as soon as 
possible, but no later than 15 calendar days after they first became aware of the reaction. 
The task of reporting other SUSARs may be delegated to the pharmacovigilance 
provider. 
The sponsor is required to notify the EC of other SUSARs as soon as possible, but no 
later than 15 calendar days after they first became aware of the reaction. The task of 
reporting other SUSARs may be delegated to the investigator. 
16.3.4 Reporting of Urgent Safety Measures 
Quotient is required to notify the MHRA and the EC of an urgent safety measure 
immediately by telephone and follow-up in writing within 3 calendar days from the date 
the measures are taken. 
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16.3.5 Reporting of COVID-19 Vaccine-Related Adverse Events 
AEs considered by the investigator to be related to COVID-19 vaccines will be reported 
to the MHRA via the Yellow Card system. 
16.4 Serious Breaches 
It is the responsibility of the sponsor to notify the MHRA of any serious breach, which is 
likely to affect, to a significant degree, the safety or mental integrity of the participants of 
the study or the scientific value of the study.  
All serious breaches will be notified to the MHRA within 7 days. The reporting will be 
performed by the party who suspects the serious breach. 
17 Protocol Amendments and Deviations 
17.1 Amendments 
After the protocol has been submitted to the MHRA and EC, any amendment must be 
agreed by the investigator after discussion with the sponsor and will be formally 
documented. 
All substantial amendments will be submitted to the MHRA and/or EC for an opinion as 
required by current regulations. 
If the PIS and ICF are updated as a result of the substantial amendment, the new 
approved versions will be used to re-consent currently enrolled participants and must be 
provided to newly enrolled participants prior to their entry into the study. 
17.2 Protocol Deviations 
The study must be conducted in accordance with the Clinical Protocol. Should a protocol 
deviation occur, it must be promptly assessed in order to decide whether any of these 
non-compliances should be reported to the MHRA as a serious breach of GCP and the 
Clinical Protocol. 
Protocol waivers are not acceptable. 
Deviations from the protocol will be recorded in the source as noted by the clinical staff. 
If necessary, the sponsor will be informed of the deviation. 
Any protocol deviations assessed as major will be discussed with the sponsor in order 
to determine if the withdrawal criteria stated in Section 8.3 have been met. 
18 Regulatory 
18.1 Compliance 
This study will be conducted in accordance with the protocol and with the following 
legislation: 
• 
ICH GCP Guidelines approved by the Committee for Medicinal Products for Human 
Use on 17 Jul 1996, which came into force on 17 Jan 1997, updated Jul 2002, 
Integrated Addendum E6 (R2) dated 09 Nov 2016 [11] 
• 
The Medicines for Human Use (Clinical Trials) Regulations. Statutory Instruments 
2004 No. 1031 [12] 
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• 
The Medicines for Human Use (Clinical Trials) Amendment Regulations. Statutory 
Instruments 2006 No. 1928 [13] 
• 
The Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations. 
Statutory Instruments 2006 No. 2984 [14] 
• 
The Medicines for Human Use (Clinical Trials) Amendment Regulations. Statutory 
Instruments 2008 No. 941 [15] 
• 
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations. 
Statutory Instruments 2019 No. 744 [16] 
In addition, the study will be performed according to the ethical principles outlined in the 
World Medical Association Declaration of Helsinki and its amendments [17]. 
18.2 MHRA and Ethical Approval 
Prior to the initiation of the study, the clinical trial of an investigational medicinal product 
(CTIMP) application, the protocol and associated documentation must be approved by 
the MHRA and given a favourable opinion by an EC. A copy of this written approval and 
any correspondence with the MHRA and EC will be available at the clinical site and will 
be provided to the sponsor.  
18.3 Source Data 
A study-specific source document identification list will be finalised with the sponsor prior 
to the start of the clinical phase of the study. The document will identify what data should 
be considered source data for this study.  
For this study, electronic data capture will be used where possible and data will be 
automatically recorded into an eCRF. In instances where paper source documents are 
used, data to be transcribed into the eCRF will be identified using a Source Document 
Identification List, as governed by Quotient’s SOPs. 
18.4 Declaration of the End of the Study 
The end of the study is defined as the point at which the sponsor determines that any 
remaining optional groups are not required to meet the objectives of the trial i.e. signed 
dose decision document or the completion of the final end of study visit or unscheduled 
follow-up assessment for the final cohort dosed, whichever occurs later. If all optional 
groups are utilised, completion of the final end of study visit or unscheduled follow-up 
visit will be considered the end of the study. Any changes to this definition will be notified 
as a substantial amendment (see Section 17.1). 
The EC and MHRA should be notified of the conclusion of the study within 90 days of 
the end of the study, or within 15 days if the study is terminated early, clearly explaining 
the reasons for the termination. 
18.5 Document Storage and Archiving 
All documentation and correspondence pertaining to the study (source data, raw data, 
letters etc) will be kept in accordance with the ICH guidelines for Good Clinical Practice 
1996, updated 2002, Integrated Addendum E6 (R2) dated 09 Nov 2016 (ICH GCP 
Section 4.9.5) [11], The Medicines for Human Use (Clinical Trials) Regulations 2004 [12], 
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 [13],[14] 
and The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 
[16]. 
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All study related documents will be retained for a minimum period of 15 years. After this 
time, the sponsor will be contacted to ascertain whether continued storage or destruction 
is required in accordance with current regulations. 
18.6 Protection of Personal Data and Confidentiality 
Personal data are securely stored to prevent unauthorised access, disclosure, 
dissemination, alteration or loss of information and unauthorised personal data 
processing. Access to personal information is restricted so that only personnel who are 
required to access personal data as part of their job role can do so. All personnel who 
access personal information are bound by a duty of confidentiality. 
Technical arrangements surrounding the electronic storage and use of data are as 
follows: 
• 
Computers storing electronic personal data are protected by antivirus software and 
the network on which computers are linked are protected by industry grade firewalls 
• 
Off-site personnel can only access networked computers through a virtual private 
network  
• 
Electronic access of data is limited according to user roles 
• 
All data are stored on password protected computers 
Organisational arrangements are as follows: 
• 
All buildings are secured by key-card access 
• 
Manual files of personal data are stored within locked cabinets/restricted areas of the 
clinical unit that can only be accessed by authorised personnel 
• 
Data security and/or confidentiality provisions are utilised in agreements with third 
parties 
• 
Documented Back-up and disaster recovery procedures are in place 
• 
Internal audit and compliance functions provide regulatory oversight 
The personal data of volunteers will be pseudonymised in that they will only include 
health, initials, date of birth and demographics (gender and ethnicity) and cannot be 
linked back to the individual by the recipient. The sponsor shall be the data controller in 
respect of the personal data of the study participants collected in connection with the 
study, and shall act in accordance with the relevant data protection laws in relation to the 
collection and processing of those personal data. The study participants’ pseudonymised 
personal data shall be collected and processed for the purposes of the study and may 
also be added to research databases and used in the future by the sponsor and its 
affiliates for certain additional clinical research, for product regulation and safety 
reporting purposes and for ensuring compliance with legal requirements. The study 
participants’ pseudonymised personal data may be processed for such purposes by 
other parties including: the sponsor’s affiliates and licensing partners, its business 
partners, regulatory agencies and other health authorities, and ECs. The study 
participants’ authorisation for such use and disclosure shall be obtained by the study 
participants signing the ICF for the study. 
Additionally, Quotient personnel are contractually bound by a duty of confidentiality and 
receive training on this matter. 
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18.7 Data Security Breach 
Quotient has a comprehensive process in place for identifying, assessing, resolving and 
reporting any potential data security breach. All staff are trained in the identification of 
potential data security breaches. Potential breaches are managed by appropriately 
trained QA personnel in accordance with Quotient’s SOPs. After robust assessment of 
data breaches, those deemed serious will be reported to the sponsor and Information 
Commissioner’s Office, as applicable. 
19 Quality Control and Quality Assurance 
Quality control of all data collected from this study will be performed in accordance with 
Quotient’s SOPs. This study (or elements thereof) may be subject to Quotient QA audit, 
in line with current internal auditing procedures. Similarly, the study (or elements thereof) 
may be subject to sponsor QA audit. 
19.1 Monitoring 
GCP requires that studies are adequately monitored. The sponsor should determine the 
appropriate extent and nature of monitoring. A study monitor, independent of Quotient, 
will be appointed to verify that the study is conducted in accordance with current GCP, 
regulatory requirements, the protocol and that the data are authentic, accurate and 
complete.  
The investigator agrees to receive visits from a study monitor and provide assistance to 
verify protocol implementation, source completion and transcription of data into the 
eCRF, document storage and AE reporting. 
Quotient will extend the professional privilege of access to the participants’ clinical 
source documents to the study monitor, EC, regulatory bodies or other authorised 
personnel (e.g. auditor) for the purposes of source data verification. 
Following completion of the study both study related documents and participant data may 
be sent to the sponsor at a location outside of the UK where data protection laws differ. 
In the interests of confidentiality, participants will not be identified on any such documents 
or data, and specific participant consent for such a disposition will be obtained. 
20 Finance and Insurance 
The sponsor (Medicines for Malaria Venture) has co-funded this study, in partnership 
with the pharmaceutical company GlaxoSmithKline. A no-fault clinical trials insurance 
has been obtained by the sponsor. The sponsor insurance will compensate participants 
in accordance with the Association of the British Pharmaceutical Industry Guidelines for 
Phase I Clinical Trials 2018 edition [9]. 
21 Publication 
Please refer to the Master Services Agreement for information on publication.  
Quotient shall have the right to publish the results of the research, subject to the 
sponsor’s prior written consent, which shall not be unreasonably withheld or delayed. 
Following the receipt of such consent, Quotient shall submit a copy of the proposed 
publication to the sponsor who shall have 30 days in which to request amendments 
thereto which, to the extent that such proposed amendments are reasonable, Quotient 
shall be obliged to incorporate prior to such publication. 
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The sponsor undertakes that, prior to publication of any information, article, paper, report 
or other material concerning the research, it will submit a copy of such publication to 
Quotient who shall have 30 days in which to request amendments thereto which, to the 
extent that such proposed amendment are reasonable, the sponsor shall be obliged to 
incorporate prior to such publication. 
22 References 
[1] 
World Health Organization, World Malaria Report, 2021. Available online: 
https://www.who.int/publications/i/item/9789240040496 
[2] 
Gamo FJ, Sanz LM, Vidal J, et al. Thousands of chemical starting points for 
antimalarial lead identification. Nature. 2010; 465 (7296): 305-310. 
[3] 
Medicines for Malaria Venture. Investigator’s Brochure for MMV367. Edition 1.0, 
06 April 2022. 
[4] 
Gaur AH, McCarthy JS, Panetta JC, et al. Safety, tolerability, pharmacokinetics, 
and antimalarial efficacy of a novel Plasmodium falciparum ATP4 inhibitor SJ733: 
a first-in-human and induced blood-stage malaria phase 1a/b trial. Lancet Infect 
Dis. 2020; 20 (8): 964-975. 
[5] 
Guideline of strategies to identify and mitigate risks for first-in-human and early 
clinical trials with investigational medicinal products. Committee for Medicinal 
Products 
for 
Human 
Use 
(CHMP) 
20 
July 
2017 
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-
strategies-identify-mitigate-risks-first-human-early-clinical-trials-
investigational_en.pdf 
[6] 
Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial 
Clinical Trials for Therapeutics in Adult Healthy Volunteers. U.S. Department of 
Health and Human Services Food and Drug Administration Center for Drug 
Evaluation 
and 
Research. 
July 
2005. 
https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/estimating-maximum-safe-starting-
dose-initial-clinical-trials-therapeutics-adult-healthy-volunteers 
[7] 
Beck A, Ward C, Mendelson M, et al. An inventory for measuring depression. 
Archives of General Psychiatry. 1961; 4: 561-571 
[8] 
Heads of Medicines Agency: Clinical Trials Facilitation Group. Recommendations 
related to contraception and pregnancy testing in clinical trials. 21 Sep 2020. 
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-
About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_gui
dance_Version_1.1_updated.pdf 
[9] 
Guidelines for Phase I Clinical Trials. Association of the British Pharmaceutical 
Industry Guidelines. London, UK; 2018 Edition (publication date 29 May 2018). 
[10] 
Longmore M, Wilkinson I, Rajagopolan S. Oxford Handbook of Clinical Medicine. 
Sixth Edition (2006): 685. 
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[11] 
International Council for Harmonisation Good Clinical Practice (GCP) Guidelines 
approved by the Committee for Medicinal Products for Human Use (CHMP) on 
17 Jul 1996, which came into force on 17 Jan 1997, updated Jul 2002, Integrated 
Addendum E6 (R2) dated 09 Nov 2016. 
[12] 
The Medicines for Human Use (Clinical Trials) Regulations. Statutory 
Instruments 2004 No. 1031. 
[13] 
The Medicines for Human Use (Clinical Trials) Amendment Regulations. 
Statutory Instruments 2006 No. 1928. 
[14] 
The Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations. 
Statutory Instruments 2006 No. 2984. 
[15] 
The Medicines for Human Use (Clinical Trials) Amendment Regulations. 
Statutory Instruments 2008 No. 941. 
[16] 
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) 
Regulations. Statutory Instruments 2019 No. 744. 
[17] 
World Medical Association, Declaration of Helsinki. Ethical Principles for Medical 
Research Involving Human Participants (and all subsequent amendments). 
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Appendix 1 Clinical Laboratory Parameters 
Haematology 
Clinical Chemistry 
Virology 
Urinalysis 
Drugs of Abuse 
Haemoglobin 
Haematocrit (HCT; packed cell 
volume [PCV]) 
Red blood cell (RBC; erythrocyte) 
count  
Mean corpuscular volume (MCV) 
Mean corpuscular haemoglobin 
(MCH) 
Mean corpuscular haemoglobin 
concentration (MCHC) 
Platelet count 
White blood cell (WBC; leukocytes) 
count 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
 
Coagulation Tests 
Prothrombin time 
International normalised ratio (INR) 
Activated partial thromboplastin time 
(APTT) 
 
Sodium 
Potassium 
Chloride 
Bicarbonate 
Urea 
Creatinine (admission plasma 
creatinine value will be used to 
calculate CLcr) 
Bilirubin (total) 
Bilirubin (direct; only if total is 
elevated) 
Alkaline phosphatase 
Aspartate aminotransferase 
(AST) 
Alanine aminotransferase 
(ALT) 
Creatine kinase (CK) 
Gamma glutamyl transferase 
(GGT) 
Protein (Total) 
Albumin 
Calcium 
Glucose (fasting) 
Glucose 
Follicle stimulating hormone 
(FSH; post-menopausal 
female participants only) 
Human chorionic 
gonadotropin (β-hCG) (in 
serum; all female participants) 
Hepatitis B surface antigen 
Hepatitis C virus antibody 
HIV 1 & 2 antibodies 
 
 
SARS-CoV-2 antigen 
 
 
 
 
Bilirubin 
Urobilinogen 
Ketones 
Glucose 
Protein 
Blood 
Nitrites 
pH 
Specific gravity 
Leukocytes 
 
At discretion of 
investigator based on 
urinalysis results 
Microbiology  
Urine microscopy 
 
Urine Pregnancy 
hCG (all female participants) 
Amphetamines 
Barbiturates 
Benzodiazepines 
Cocaine 
Marijuana/cannabis 
Methadone 
Methamphetamine/ 
ecstasy 
Morphine/opiates 
Phencyclidine 
Tricyclic antidepressants 
 
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Appendix 2 
Schedule of Assessments: Part 1 (Cohorts 1A to 1E) 
Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb End of Study 
Visitb 
-28 to -2 
-1 
1 
2 
3 
4 
5a 
7 
15 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
Xd 
Xd 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath Test 
X 
X 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
Targeted (symptom driven) Physical 
Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
X 
 
 
X 
X 
X 
Urinalysisi 
X 
X 
 
X 
 
 
X 
X 
X 
Follicle-stimulating Hormone (FSH) Testj 
X 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
X 
X 
Single 12-Lead ECGsl 
X 
X 
X 
X 
 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
 
X 
X 
X 
X 
 
Holter Periodsm 
  
 
X 
X 
 
 
 
 
 
Telemetryn 
 
 
X 
 
 
 
 
 
 
Vital Signso 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Orthostatic Vital Signso 
X 
 
X 
X 
 
 
 
X 
 
Adverse Events 
< ---------------------------------------------------------------------------X--------------------------------------------------------------------------> 
Prior and Concomitant Medication 
< ---------------------------------------------------------------------------X------------------------------------------------------------------------ > 
PK/Metabolite ID/Pharmacogenetic Assessments 
Plasma Samples for MMV367p 
 
 
X 
X 
X 
X 
X 
X 
 
Urine Samples for MMV367pq 
 
 
X 
X 
X 
 
 
 
 
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Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb End of Study 
Visitb 
-28 to -2 
-1 
1 
2 
3 
4 
5a 
7 
15 
Blood Sample for CYP/UGT 
polymorphismr 
 
 
X 
 
 
 
 
 
 
Taste/Palatability Assessments 
Taste/Palatability Questionnaires 
 
 
 
 
 
 
 
 
 
Eligibility will be re-assessed at admission/pre-dose on Day 1. 
a Discharge from clinical unit 
b Participants will return for an outpatient visit on Day 7 and an end of study visit on Day 15 (± 1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 
testing time points are subject to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the 
Clinical Kick-Off Meeting minutes. 
f Participants will be randomised on the morning of Day 1 prior to dosing 
g Participants will receive a single dose of MMV367 or placebo on Day 1 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation and clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at 
screening. See Appendix 5 for safety blood sample time points. 
j Post-menopausal female participants only 
k All female participants 
l See Appendix 5 for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external 
stimuli (e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position 
with no external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See Appendix 5 for Holter 
extraction time points. 
n Telemetry (continuous ECG monitoring) will commence at least 30 min before dosing until at least 12 h post-dose. 
o Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening/admission only. See Appendix 5 for vital signs 
and orthostatic vital signs time points. 
p See Appendix 5 for PK sample time points. Metabolite profiling of MMV367 in plasma and urine will be performed using existing PK samples (pooled residual 
samples). 
q Urine collection in Cohorts 1C and 1D only. 
r Sample will be taken prior to IMP administration (≤2 h before dosing). 
s The taste/palatability questionnaire will be completed immediately after IMP administration, see Appendix 9 for details. 
 
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Appendix 3 
Schedule of Assessments: Part 2 
 
 
 
Resident in Clinic 
End of Study 
Visit 
Study Day 
Screening 
Admi-
ssion 
Period 1 
Period 2 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12a 
14b 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath 
Test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted (symptom driven) 
Physical Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
X 
X 
Urinalysisi 
X 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
X 
X 
Follicle-stimulating Hormone 
(FSH) Testj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Single 12-Lead ECGsl 
X 
X 
X 
X 
 
 
 
 
 
X 
X 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
 
Holter Periodsm 
 
 
X 
X 
 
 
 
 
 
X 
X 
 
 
 
 
Telemetryn 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Vital Signso 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
< --------------------------------------------------------------------------X----------------------------------------------------------------------- > 
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Resident in Clinic 
End of Study 
Visit 
Study Day 
Screening 
Admi-
ssion 
Period 1 
Period 2 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12a 
14b 
Prior and Concomitant 
Medication 
< --------------------------------------------------------------------------X----------------------------------------------------------------------- > 
PK/Pharmacogenetic Assessments 
Plasma Samples for 
MMV367p 
 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Blood Sample for CYP/UGT 
polymorphismq 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility will be re-assessed at admission/pre-dose on Day 1.  
a Discharge from clinical unit 
b Participants will return for an end of study visit on Day 14 (± 1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 
testing time points are subject to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the 
Clinical Kick-Off Meeting minutes. 
f Participants will be randomised on the morning of Period 1, Day 1 prior to dosing 
g Participants will receive a single dose of MMV367 on Day 1 and Day 8 in the fed or fasted state 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation, clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at screening. 
j Post-menopausal female participants only 
k All female participants 
l See Appendix 6 for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external 
stimuli (e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position 
with no external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See Appendix 6 for Holter 
extraction time points. 
n Telemetry (continuous ECG monitoring) will commence at least 30 min before dosing until at least 12 h post-dose. 
o Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening and admission only. See Appendix 6 for vital 
signs time points. 
p See Appendix 6 for PK sample time points. 
q Sample will be taken prior to IMP administration (≤2 h before dosing). 
 
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Appendix 4 
Schedule of Assessments: Part 3 (Cohorts 3A to 3C) 
Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb End of Study 
Visitb 
 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7a 
9 
17 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
 
 
Xd 
Xd 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
X 
X 
 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
 
 
Targeted (symptom driven) Physical 
Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
 
X 
 
X 
 
X 
X 
X 
Urinalysisi 
X 
X 
 
 
X 
 
X 
 
X 
X 
X 
Follicle-stimulating Hormone (FSH) 
Testj 
X 
 
 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
 
 
X 
X 
Single 12-Lead ECGsl 
X 
X 
X 
 
X 
X 
 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
X 
 
X 
X 
X 
X 
X 
 
Holter Periodsm 
 
 
X 
X 
X 
X 
 
 
 
 
 
Vital Signsn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Orthostatic Vital Signsn 
X 
 
X 
X 
X 
X 
 
 
 
X 
 
Adverse Events 
< ------------------------------------------------------------------------X------------------------------------------------------------------ > 
Prior and Concomitant Medication 
< ------------------------------------------------------------------------X------------------------------------------------------------------ > 
PK/Pharmacogenetic Assessments 
Plasma Samples for MMV367o 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
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Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb End of Study 
Visitb 
 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7a 
9 
17 
Blood Sample for CYP/UGT 
polymorphismp 
 
 
X 
 
 
 
 
 
 
 
 
Eligibility will be re-assessed at admission/pre-dose on Day 1. 
a Discharge from clinical unit 
b Participants will return for an outpatient visit on Day 9 and an end of study visit on Day 17 (± 1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 
testing time points are subject to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the 
Clinical Kick-Off Meeting minutes. 
f Participants will be randomised on the morning of Day 1 prior to dosing 
g Participants will receive a dose of MMV367 or placebo in the morning on Days 1, 2 and 3 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation, clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at screening. 
j Post-menopausal female participants only 
k All female participants 
l See Appendix 6 for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external 
stimuli (e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position 
with no external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See Appendix 6 for Holter 
extraction time points. 
n Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening and admission only. See Appendix 6 for vital 
signs and orthostatic vital signs time points. 
o See Appendix 6 for PK sample time points. 
p Sample will be taken prior to IMP administration (≤2 h before dosing). 
 
 
 
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Appendix 5 
Part 1 (All Cohorts) Safety and Pharmacokinetic Assessment Time Points 
(Days 1 to 7) 
Study Day 
Time point 
Plasma 
PK 
Urine PKa 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital 
Signsb 
Orthostatic 
Vital Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
 
X 
 
 
X 
 
-1 h 
 
 
 
X 
 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
X 
 
X 
X 
X 
X 
 
0 h 
 
0 to 6 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
 
X 
 
1 h 
X 
 
X 
 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
X 
 
6 h 
X 
6 to 12 h 
 
X 
X 
 
X 
 
8 h 
X 
 
X 
X 
 
X 
 
10 h 
 
 
 
X 
 
 
 
12 h 
X 
12 to 24 h 
 
X 
X 
X 
X 
 
2 
24 h 
X 
24 to 48 h 
X 
X 
X 
X 
X 
 
3 
48 h 
X 
48 to 72 h 
 
 
X 
 
 
X 
4 
72 h 
X 
 
 
 
X 
 
 
X 
5 
96 h 
X 
 
X 
 
X 
 
 
X 
7 
144 h 
X 
 
X 
 
X 
X 
 
X 
a Part 1, Cohorts 1C and 1D only. 
b Blood pressure, heart rate and respiratory rate at all time points. 
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Sections 13.1, 14.6 and 14.7. 
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Appendix 6 
Part 2 Safety and Pharmacokinetic Assessment Time Points (Days 1 to 14) 
Study Day 
Time point 
Plasma 
PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
X 
 
X 
 
-1 h 
 
 
X 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
X 
 
1 h 
X 
 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
 
3 h 
X 
 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
8 h 
X 
 
X 
X 
X 
 
10 h 
 
 
 
X 
 
 
12 h 
X 
 
X 
X 
X 
 
2 
24 h 
X 
X 
X 
X 
X 
 
3 
48 h 
X 
 
 
X 
 
X 
4 
72 h 
X 
 
 
X 
 
X 
5 
96 h 
X 
X 
 
X 
 
X 
7 
144 h 
X 
X 
 
X 
 
X 
8 
-1.5 h 
 
 
X 
 
X 
 
-1 h 
 
 
X 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
X 
 
1 h 
X 
 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
 
3 h 
X 
 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
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Study Day 
Time point 
Plasma 
PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
8 h 
X 
 
X 
X 
X 
 
10 h 
 
 
 
X 
 
 
12 h 
X 
 
X 
X 
X 
 
9 
24 h 
X 
 
X 
X 
X 
 
10 
48 h 
X 
X 
 
X 
 
X 
11 
72 h 
X 
 
 
X 
 
X 
12 
96 h 
X 
X 
 
X 
 
X 
14 
144 h 
X 
X 
 
X 
 
X 
a Blood pressure, heart rate and respiratory rate at all time points. 
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Sections 13.1, 14.6 and 14.7. 
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 08 SEP 2022 
Page 85 of 92  
 
Appendix 7 
Part 3 Safety and Pharmacokinetic Assessment Time Points (Days 1 to 9) 
Study 
Day 
Time point 
Plasma PK 
Safety Labs 
and Urinalysis 
Holter Extractions 
Vital Signsa 
Orthostatic 
Vital Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
X 
 
 
X 
 
-1 h 
 
 
X 
 
 
X 
 
Pre-dose (-0.5 h) 
X 
 
X 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
 
0.5 h 
X 
 
X 
 
 
 
 
1 h 
X 
 
X 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
X 
 
8 h 
X 
 
X 
X 
 
X 
 
10 h 
 
 
X 
X 
 
 
 
11 h 
 
 
 
 
 
 
 
12 h 
X 
 
X 
X 
X 
X 
 
2 
-1.5 h 
 
 
 
 
 
 
X 
-1 h 
 
 
 
 
 
 
X 
Pre-dose (-0.5 h)b 
X 
 
X (Day 1, 24 h) 
X 
X (Day 1, 24 h) 
 
X 
0 h 
 
 
 
 
 
 
 
1 h 
 
 
 
 
 
 
 
2 h 
 
 
 
 
 
 
 
3 h 
 
 
 
 
 
 
 
4 h 
X 
 
 
X 
 
 
X 
5 h 
 
 
 
 
 
 
 
6 h 
X 
 
 
X 
 
 
X 
7 h 
 
 
 
 
 
 
 
8 h 
 
 
 
 
 
 
 
9 h 
 
 
 
 
 
 
 
10 h 
 
 
 
X 
 
 
 
11 h 
 
 
 
 
 
 
 
12 h 
X 
 
 
X 
 
 
X 
3 
-1.5 h 
 
 
X 
 
 
X 
 
-1 h 
 
 
X 
 
 
X 
 
Pre-dose (-0.5 h)c 
X 
X (Day 1, 48 h) 
X (Day 1, 48 h) 
X 
X 
X 
 
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 08 SEP 2022 
Page 86 of 92  
 
Study 
Day 
Time point 
Plasma PK 
Safety Labs 
and Urinalysis 
Holter Extractions 
Vital Signsa 
Orthostatic 
Vital Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
0 h 
 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
 
X 
 
1 h 
X 
 
X 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
 
8 h 
X 
 
X 
X 
 
X 
 
9 h 
 
 
 
 
 
 
 
10 h 
 
 
X 
X 
 
 
 
11 h 
 
 
X 
 
 
 
 
12 h 
X 
 
X 
X 
X 
X 
 
4 
24 h 
X 
 
X 
X 
X 
X 
 
36 h 
X 
 
 
X 
 
 
X 
5 
48 h 
X 
X 
 
X 
 
 
X 
6 
72 h 
X 
 
 
X 
 
 
X 
7 
96 h 
X 
X 
 
X 
 
 
X 
9 
144 h 
X 
X 
 
X 
X 
 
X 
a Blood pressure, heart rate and respiratory rate at all time points. 
b 24 h post-dose Day 1 sample will be taken pre-dose on Day 2  
c 24 h post-dose Day 2 sample will be taken pre-dose on Day 3  
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Sections 13.1, 14.6 and 14.7. 
 
 
 
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 08 SEP 2022 
Page 87 of 92  
 
Appendix 8 
Breakfast Content (Part 2 only) 
Meal Description 
Energy from 
Fat (%) 
Composition 
High-Fat Breakfast 
(FDA approved)a 
57.90 
1 (40 g) hash brown, 2 (80 g) smoked rindless streaky bacon, 1 medium (45 g) egg fried in 10 g of butter, 
2 slices (95 g) of white sliced bread with 20 g of butter, 240 mL of full fat milk 
Values/content are approximate. Every effort will be made to include the items described above; however, items may be replaced as long as they contain the 
equivalent nutritional content as the item it has replaced. 
a For FDA high-fat breakfast, if a replacement item is required it will be of comparable volume and viscosity. 
 
 
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Page 88 of 92  
 
Appendix 9 
Example Taste/Palatability Questionnaire  
An example of the taste/palatability questionnaire can be found on the next page. 
 
 
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 08 SEP 2022 
Page 89 of 92  
 
QSCXXXXXX (Sponsor Study Number) Taste Questionnaire 
 
Study Part:  
 
Test Product:  
 
Participant Number:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Initials:  
 
 
Start time:  
 
  
 
 
 
 
 
 
 
 
 
 
(to be completed within 10 minutes of tasting) 
 
Date:  
 
  
 
 
  
 
 
 
Question 1 
All aspects considered (smell, sweetness, bitterness, flavour, mouthfeel/texture, grittiness, and aftertaste), how would you rate your overall liking 
of this product:  
NOTE: Tick 1 box below in blue or black pen 
Question 2 
We want to know how much you like certain aspects of the product: smell, sweetness, bitterness, flavour, mouthfeel/texture, grittiness, and 
aftertaste. NOTE: Tick 1 box in the row for each aspect 
 
Dislike 
extremely 
Dislike very 
much 
Dislike 
moderately 
Dislike 
slightly 
Neither like 
nor dislike Like slightly 
Like 
moderately 
Like very 
much 
Like 
extremely 
N/A 
Smell 
 
 
 
 
 
 
 
 
 
 
Sweetness 
 
 
 
 
 
 
 
 
 
 
Bitterness 
 
 
 
 
 
 
 
 
 
 
Flavour 
 
 
 
 
 
 
 
 
 
 
Mouthfeel/texture 
 
 
 
 
 
 
 
 
 
 
Grittiness 
 
 
 
 
 
 
 
 
 
 
Aftertaste 
 
 
 
 
 
 
 
 
 
 
Entered 
into 
eCRF 
by 
(initials): 
 
Date: 
 
QC checked by (initials):  
Date: 
 
Dislike 
extremely 
Dislike very 
much 
Dislike 
moderately 
Dislike slightly 
Neither like nor 
dislike 
Like slightly 
Like 
moderately 
Like very much 
Like extremely 
 
 
 
 
 
 
 
 
 
 
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 08 SEP 2022 
Page 90 of 92  
 
Appendix 10 
Protocol Amendment Summary of Changes 
Version 3.0 dated 08 Sep 2022 
Due to logistics within the Quotient screening facility, it would be difficult to ensure 
subjects attend their end of study visit and have all the procedures performed within the 
± 1 h window, and would likely result in protocol deviations. Therefore, it was agreed to 
increase this window from ± 1 h to ± 1 day. 
In addition, clarifications were made throughout the protocol regarding the collection of 
urine for PK assessments, to ensure it is specific to Part 1, Cohorts 1C and 1D. 
Changes were also made to correct previous errors and inconsistencies. These changes 
include: 
• 
The removal of a physical examination and Holter procedure from Part 2 and Part 3 
appendices, respectively; 
• 
The addition of an ECG measurement to the Part 1 appendix; 
• 
The removal of an incorrect sentence from Section 14.7 ECG Measurements and 
14.8 Holter (continuous ECG) Monitoring; 
• 
The specification of which parts exclusion criterion 5 refers to; 
• 
An update to the Sponsor’s Clinical Lead/Contact details in the study contacts and 
sponsor signature page following a change in personnel; 
• 
The shading of blank boxes in the appendices tables to improve readability. 
In addition, minor typographical updates were made throughout. 
As these changes do not significantly affect the scientific value of the trial, the safety or 
physical or mental integrity of the subjects of the trial, this amendment was considered 
to be non-substantial. 
All relevant sections of the protocol were updated accordingly, including: 
• 
Document History Page 
• 
Section 3 Synopsis 
• 
Section 8.1.1 Study Plan: Part 1 – Single Ascending Dose Cohorts 
• 
Section 8.1.2 Study Plan: Part 2 – Food Effect Cohort 
• 
Section 8.1.3 Study Plan: Part 3 – Multiple Dose Cohort(s) 
• 
Section 9.3 Exclusion Criteria 
• 
Section 10.3.5 End of Study Visits 
• 
Section 13.1.1 Blood Sampling for Pharmacokinetics and Metabolite Identification 
• 
Section 14.5.1 Haematology, Clinical Chemistry and Coagulation 
• 
Section 14.5.2 Urinalysis 
• 
Section 14.6 Vital Signs Measurements 
• 
Section 14.7 ECG Measurements 
• 
Section 14.8 Holter (continuous ECG) Monitoring 
• 
Section 15.3 Pharmacokinetic Data Analysis 
• 
Appendix 2 Schedule of Assessments: Part 1 (Cohorts 1A to 1E) 
• 
Appendix 3 Schedule of Assessments: Part 2 
• 
Appendix 4 Schedule of Assessments: Part 3 (Cohorts 3A to 3C) 
• 
Appendix 5 Part 1 (All Cohorts) Safety and Pharmacokinetic Assessment Time Points 
(Days 1 to 7) 
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 08 SEP 2022 
Page 91 of 92  
 
• 
Appendix 7 Part 3 Safety and Pharmacokinetic Assessments Time Points (Days 1 to 
9) 
• 
Signatures for Sponsor Page 
Version 2.0 dated 01 Jun 2022 
The following revision was made to the protocol in response to a Grounds for 
Non-Acceptance (GNA) request from the MHRA: 
Section 8.5 (Overall Study Stopping Rules): The following stopping criterion, “At least 
three participants experience a similar AE assessed as severe and considered related 
to IMP” has been replaced with: “Two severe non-serious adverse reactions considered 
as, at least, possibly related to the IMP administration in two subjects in the same cohort, 
independent of within or not within the same system-organ-class are observed”. 
 
Signatures for Quotient Sciences 
CONFIDENTIALITY AND GCP COMPLIANCE STATEMENT 
I confirm that I have read and that I understand this protocol, the Investigator’s Brochure, 
and any other product information provided by the sponsor. I agree to conduct this study 
in accordance with the requirements of this protocol and also protect the rights, safety, 
privacy, and well-being of study participants in accordance with the following: 
• 
The ethical principles that have their origin in the Declaration of Helsinki. 
• 
International 
Council 
for 
Harmonisation 
of 
Technical 
Requirements 
for 
Pharmaceuticals for Human Use E6 (R2) Good Clinical Practice: Consolidated 
Guideline. 
• 
All applicable laws and regulations, including, without limitation, data privacy laws 
and regulations. 
• 
Regulatory requirements for reporting serious adverse events defined in Section 16.3 
of this protocol. 
Information taken from the study protocol may not be disseminated or discussed with a 
third party without the express consent of the sponsor. 
Nand Singh BSc, MD, DPM, MFPM  
See electronic signature at the end of the 
document 
Principal Investigator 
Signature 
Senior Clinical Research Physician 
 
 
Date 
 
 
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Page 92 of 92
Signatures for Sponsor
Stephan Chalon, MD, PhD
VP - Head Experimental & Clinical 
Pharmacology
Signature
Date
Myriam El Gaaloul
Director, Clinical Sciences
Signature
Date
September 9th, 2022
9-Sep-2022
ature
p-2022


Document Approvals
Approved Date: 09 Sep 2022
Document Author(s):  Gemma Bell 
Approval Task
Verdict:  Approve
Nand Singh, Medical Director
(Nand.Singh@quotientsciences.com)
Functional / Technical Approval
09-Sep-2022 11:02:12 GMT+0000
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SAP_001.pdf: 
 
Quotient Confidential 
Doc No: DOC-101489 
 
Version: 2.0 
 
Status: Ready for Approval 
Doc Name: QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan 
Project Number: 207031 
 
 
 
Governing SOP: DOC-03176 
 
REPORTING AND ANALYSIS PLAN 
A First-in-Human, Single-Centre, Single Ascending Dose, 
Multiple Dose and Pilot Food Effect Study to Assess the Safety, 
Tolerability and Pharmacokinetics of MMV367 in Healthy 
Participants 
 
Quotient Study Number: 
QSC207031 
Sponsor Study Number: 
MMV_MMV367_21_01 
 
 
 
 
Sponsor: 
Medicines for Malaria Venture 
 
ICC - Block 3, 3rd Floor 
 
20 Route de Pré-Bois 
 
PO Box 1826 
 
1215 Geneva 15 
 
Switzerland 
 
 
Date of RAP: 
15 Dec 2022 
 
 
Status of RAP: 
Final v2.0 
 
 
 
 
Document Version History 
Version 
Number 
Reason for Update 
Updated By: 
Date 
v1.0 
Initial version 
Claire Wilson 
11 Jul 2022 
v2.0 
Amended to include 
protocol v3.0 updates 
Claire Wilson 
15 Dec 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SPONSOR/QUOTIENT SCIENCES CONFIDENTIAL 
 
This Reporting and Analysis Plan may not be reproduced or communicated to a third 
party without the written permission of  Medicines for Malaria Venture (MMV).
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19 Dec 2022
See electronic signature at end of document
See electronic signature at end of document
See electronic signature at end of document
See electronic signature at end of document
See electronic signature at end of document
19 Dec 2022
19 Dec 2022
19 Dec 2022
19 Dec 2022
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 3 of 128  
1 Table of Contents 
1 
Table of Contents .............................................................................. 3 
2 
List of Abbreviations .......................................................................... 6 
3 
Introduction ........................................................................................ 9 
3.1 
Responsibilities ................................................................................. 9 
3.2 
Definitions.......................................................................................... 9 
3.2.1 
Subject Definitions ............................................................................. 9 
3.2.2 
Definition of Treatments ................................................................... 10 
3.2.3 
Definition of Visits ............................................................................ 11 
4 
Objectives and Endpoints ................................................................ 11 
5 
Study Design ................................................................................... 12 
5.1 
Brief Description .............................................................................. 12 
5.1.1 
Part 1 – Single Ascending Dose Cohorts ......................................... 12 
5.1.2 
Part 2 – Food Effect Cohort ............................................................. 13 
5.1.3 
Part 3 – Multiple Dose Cohort(s) ...................................................... 14 
5.2 
Criteria for In-Study Decisions ......................................................... 15 
5.2.1 
Decision Points ................................................................................ 15 
5.2.2 
Criteria for Dose Decision ................................................................ 15 
5.3 
Study Sample Size .......................................................................... 17 
5.4 
Randomisation (including Replacement Subjects) ........................... 17 
5.4.1 
Participant Numbers ........................................................................ 18 
5.5 
Blinding Issues ................................................................................ 19 
5.6 
Unblinding procedures ..................................................................... 20 
5.7 
Maintaining the Blind During Interim PK Analyses ........................... 20 
6 
Populations and Analysis Sets......................................................... 20 
6.1 
Safety Population and Safety Analysis Set ...................................... 20 
6.2 
Taste Population and Taste Analysis Set ........................................ 20 
6.3 
Pharmacokinetic Population and Pharmacokinetic Analysis Set(s) .. 21 
7 
Participant Disposition, Demographics and Baseline Characteristics
 
22 
7.1 
Screening Failures ........................................................................... 22 
7.2 
Participant Disposition and Withdrawals .......................................... 22 
7.3 
Analysis Populations ....................................................................... 22 
7.4 
Analysis Sets and Subsets .............................................................. 23 
7.5 
Demographic Characteristics and Lifestyle Details .......................... 23 
7.6 
Medical History ................................................................................ 23 
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Page 4 of 128  
7.7 
Prior and Concomitant Medication ................................................... 23 
7.8 
Other Baseline Characteristics ........................................................ 24 
8 
Efficacy ............................................................................................ 24 
9 
Pharmacokinetics ............................................................................ 24 
9.1 
Plasma PK Parameter Estimation .................................................... 24 
9.1.1 
Definition of Plasma PK Parameters ................................................ 24 
9.1.2 
Rules for Plasma PK Parameter Estimation using WinNonlin .......... 27 
9.1.3 
Plasma PK Parameter Reporting Specifications .............................. 28 
9.2 
Urine PK Parameter Estimation ....................................................... 29 
9.2.1 
Definition of Urine PK Parameters ................................................... 30 
9.3 
Concentration and PK Parameter Summary Tables ........................ 31 
9.4 
Concentration and PK Figures ......................................................... 31 
9.5 
Concentration and PK Listings ......................................................... 32 
9.6 
Statistical Analysis of PK Parameters .............................................. 32 
9.6.1 
Part 1 and Part 3: Assessment of Dose Proportionality.................... 32 
9.6.2 
Part 2: Assessment of Food Effect .................................................. 34 
9.6.3 
Statistical Figures for Analysis of Pharmacokinetic Data .................. 35 
9.7 
Interim Pharmacokinetic Analysis .................................................... 35 
10 
Taste Assessment ........................................................................... 36 
10.1 
Summary Tables for Taste Questionnaire Assessments.................. 36 
10.2 
Listings for Taste Questionnaire Assessments ................................ 36 
10.3 
Statistical Figures for Analysis of Taste Questionnaire Data ............ 36 
11 
Safety Assessments ........................................................................ 36 
11.1 
Extent of Exposure and Treatment Compliance ............................... 36 
11.2 
Meal Details ..................................................................................... 37 
11.3 
Adverse Events ............................................................................... 37 
11.3.1 
Summary Tables for Adverse Events ............................................... 38 
11.3.2 
Listings for Adverse Events ............................................................. 40 
11.4 
Laboratory Evaluations .................................................................... 41 
11.4.1 
Summary Tables for Laboratory Evaluations ................................... 41 
11.4.2 
Listings for Laboratory Evaluations .................................................. 41 
11.5 
Vital Signs ....................................................................................... 42 
11.5.1 
Summary Tables for Vital Signs ....................................................... 42 
11.5.2 
Listings for Vital Signs ..................................................................... 42 
11.6 
ECGs ............................................................................................... 43 
11.6.1 
Summary Tables for ECGs .............................................................. 43 
11.6.2 
Listings for ECGs ............................................................................. 44 
11.7 
Body Weight .................................................................................... 44 
11.8 
Physical Examination ...................................................................... 45 
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Page 5 of 128  
12 
Interim Statistical Analyses .............................................................. 45 
13 
Changes in the Conduct of the Study or Planned Analysis .............. 45 
13.1 
Changes in the Conduct of the Study .............................................. 45 
13.2 
Changes to the Planned Analyses ................................................... 45 
13.3 
Any Other Relevant Changes .......................................................... 45 
14 
Overall Considerations .................................................................... 45 
14.1 
Statistical Programming and Analysis .............................................. 45 
14.2 
Quality Control of Summary Tables, Figures and Listings and 
Statistical Analysis................................................................................................... 47 
14.2.1 
Quality Control - Summary Tables ................................................... 47 
14.2.2 
Quality Control - Figures .................................................................. 48 
14.2.3 
Quality Control - Data Listings ......................................................... 48 
14.2.4 
Quality Control - Statistical Analysis ................................................ 48 
15 
SAS Data Transfer .......................................................................... 48 
16 
Programming Conventions .............................................................. 49 
17 
Reference List ................................................................................. 49 
18 
Index of Tables ................................................................................ 50 
19 
Index of Figures ............................................................................... 58 
20 
Index of Listings............................................................................... 62 
21 
Mock Tables .................................................................................... 73 
Appendix 1 
Schedule of Assessments: Part 1 (Cohorts 1A to 1E) .................... 115 
Appendix 2 
Schedule of Assessments: Part 2 .................................................. 117 
Appendix 3 
Schedule of Assessments: Part 3 (Cohorts 3A to 3C) .................... 119 
Appendix 4      Part 1 (All Cohorts) Safety and Pharmacokinetic Assessment Time Points 
(Days 1 to 7) 
121 
Appendix 5 
Part 2 Safety and Pharmacokinetic Assessment Time Points (Days 1 
to 14) 
122 
Appendix 6 
Part 3 Safety and Pharmacokinetic Assessment Time Points (Days 1 
to 9) 
124 
Appendix 7 
Example Taste/Palatability Questionnaire ..................................... 127 
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Page 6 of 128  
2 List of Abbreviations 
ADaM 
analysis data model  
AE 
adverse event 
ATC 
anatomical therapeutic chemical 
AUC 
area under the curve  
BLQ 
below the limit of quantification 
BMI 
body mass index 
BP 
blood pressure 
CDISC 
Clinical Data Interchange Standards Consortium 
CHMP 
Committee for Medicinal Products for Human Use 
CI 
confidence interval 
COVID-19 
Coronavirus disease 2019 
CS 
clinically significant 
CSR 
clinical study report 
CV% 
coefficient of variation 
D 
‘substantial’ decrease from baseline for vital signs parameters 
DP 
decimal place 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
F 
absolute bioavailability 
Frel 
relative bioavailability 
GMR 
geometric mean ratio 
h 
hour 
H 
flag used for value that is above normal reference range 
HR 
heart rate 
I 
‘substantial’ increase from baseline for vital signs parameters / 
increase in QTcF interval from baseline 
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Page 7 of 128  
ICH 
International Council for Harmonisation 
IMP 
investigational medicinal product 
ISF 
Investigator Site File 
L 
flag used for value that is below normal reference range 
LLOQ 
lower limit of quantification 
LOCF 
last observation carried forward 
Max 
maximum 
MedDRA 
Medical Dictionary for Regulatory Activities 
Min 
minimum 
MPR 
metabolite to parent ratio 
n 
number of subjects with an observation 
N 
number of subjects in the dataset 
NA 
not applicable 
NC 
not calculated 
NR 
not reportable/no result 
NS 
no sample 
PI 
principal investigator 
PK 
pharmacokinetic 
PT 
preferred term 
QC 
quality control 
QTcB 
QT interval corrected for heart rate using Bazett’s correction 
QTcF 
QT interval corrected for heart rate using Fridericia’s correction 
RAP 
reporting and analysis plan 
SAC 
safety advisory committee 
SAE 
serious adverse event 
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Page 8 of 128  
SD 
standard deviation 
SDTM 
study data tabulation model 
SF 
significant figure 
SI 
substantial increase in QTcF interval from baseline 
SOC 
system organ class 
SOP 
standard operating procedure 
TEAE 
treatment-emergent adverse event 
TFL 
tables, figures and data listings 
WHO  
World Health Organisation  
 
 
Abbreviations used for pharmacokinetic parameters and associated flags are defined in 
Section 9.1.1, and Section 9.1.3 respectively. 
 
 
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3 Introduction 
This document details the following for Quotient Sciences (Quotient) Study QSC207031 
(MMV_MMV367_21_01): 
• 
Criteria to be used for the definition of the populations and analysis sets relating to 
safety, taste and pharmacokinetic (PK) data 
• 
Handling of missing data 
• 
Proposed tables, figures and data listings (TFLs) for demographic, dosing, safety 
and PK data 
• 
Methods for PK parameter estimation and the formal statistical analysis  
This document has been compiled according to the Quotient standard operating 
procedure (SOP) “Production of Reporting and Analysis Plans” and has been written 
based on information contained in the final study protocol (v3.0) dated 08 Sep 2022. 
The v1.0 RAP was amended to incorporate updates from the v3.0 protocol, which 
included increasing the window of the end of study visit in each study part, from ± 1 h to 
± 1 day. Thus, ensuring sufficient time to complete all agreed procedures. Furthermore, 
additional clarification relating to the collection of urine for PK assessments has also 
been included. 
3.1 
Responsibilities 
The Data Sciences Department at Quotient will be responsible for the production of the 
following items using Quotient SOPs: Clinical Data Interchange Standards Consortium 
(CDISC) study data tabulation model (SDTM) and analysis data model (ADaM) datasets, 
safety and PK outputs; including all TFLs, and formal statistical analysis; and the clinical 
study report (CSR). 
Quotient will provide two sets of TFLs during the study: 
• 
Post database lock TFLs (draft) for MMV review 
• 
Post-review TFLs (final) for inclusion into the CSR 
Quotient will be responsible for the quality control (QC) of all deliverables prior to the 
client review (Section 14.2). 
All Holter ECGs will be collected electronically using a Mortara H12+ Holter Recorder 
and analysed by Banook. The reporting of the ECG Holter data is not the responsibility 
of Quotient and will be  subject of a separate analysis plan and will not be part of the final 
study CSR. 
If required, metabolite profiling and genetic testing will the responsibility of The Doctors 
Laboratory and will be the subject of a separate analytical work plan should the analysis 
be required. Metabolite profiling may be included in the CSR as an addendum, however 
genetic testing will be reported separately.  
3.2 
 
Definitions 
3.2.1 Subject Definitions 
During the clinical phase of the study, an evaluable participant in Part 1 and Part 3 is 
defined as a participant who received the study drug and completed safety and PK 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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assessments up to 96 h post-dose (Part 1)/post-final dose (Part 3). In Part 2, a participant 
will be considered evaluable if they have received the study drug and completed safety 
and PK assessments up to 96 h post-dose in both periods. This will be monitored during 
the clinical phase to identify any requirement for replacement subjects. This definition 
will not be used during the reporting phase including the identification of analysis 
populations and datasets which are defined in Section 5.7. 
In all study parts, an enrolled participant is defined as a participant who signed the 
informed consent, qualified per the inclusion/exclusion criteria, and was randomised.  
3.2.2 Definition of Treatments 
Throughout the reporting of the study, the test product will be referred to as MMV367 
and the investigational medicinal products (IMPs) relating to each study part are 
presented in Table 1, Table 2 and Table 3, respectively. 
Table 1  
Description of Regimens: Part 1 
SAD 
Cohort 
Regimen 
IMP 
Dose 
Route of 
Administration 
TFL Label 
1A 
1 
MMV367 or placebo 
100 mg 
Oral, Fasted 
100 mg 
1B 
2 
MMV367 or placebo 
300 mga 
Oral, Fasted 
300 mg 
1C 
3 
MMV367 or placebo 
750 mga 
Oral, Fasted 
750 mg 
1D 
4 
MMV367 or placebo 
1500 mga 
Oral, Fasted 
1500 mg 
1E 
Optional 
5 
MMV367 or placebo 
2000 mga 
Oral, Fasted 
2000 mg 
a Predicted dose 
Table 2 
Description of Regimens: Part 2 
Food Effect 
Cohort 
Period 
Regimen 
IMP 
Dosea 
Route of 
Administration 
TFL Label 
2A 
1 and 2 
(randomised) 
6 
MMV367 
XX mg 
Oral, Fasted 
XX mg Fast 
7 
MMV367 
XX mg 
Oral, Fed 
XX mg Fed 
a The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of 
MMV367 and a safe exposure window has been established in Part 1. The dose for Regimens 6 and 7 will 
be the same. 
Table 3 
Description of Regimens: Part 3 
Multiple Dose 
Cohort 
Regimen 
IMP 
Dosea 
Route of 
Administration 
TFL Label 
3A 
8 
MMV367 or 
placebo 
XX mg for 
3 days 
Oral, Fasted 
XX mg 
3B 
Optional 
9 
MMV367 or 
placebo 
XX mg for 
3 days 
Oral, Fasted 
XX mg 
3C 
Optional 
10 
MMV367 or 
placebo 
XX mg for 
3 days 
Oral, Fasted 
XX mg 
a The dose(s) administered in Part 3 will be determined after review of the data from Part 1. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Where pooling of active or placebo subjects is required within a study part (i.e., safety 
summaries in Part 1 and Part 3) these will be presented as All Active and All Placebo 
respectively. 
3.2.3 Definition of Visits 
For clinical data, visits will be referred to as Day throughout this document, and each 
Day will be stated as screening, Day -1 (Admission), with the following duration based 
on study Part: 
• 
Part 1: Day 1 through to Day 5, with a return visit on Day 7 and an end of study visit 
on Day 15  
• 
Part 2: Day 1 through to Day 7 Period 1, and Day 8 through to Day 12 in Period 2, 
with an end of study visit on Day 14 (The actual dosing days within Period 2 may 
change if the washout period is extended – see Section 8.1.2 of the study protocol) 
• 
Part 3: Day 1 through to Day 7, with a return visit on Day 9 and an end of study visit 
on Day 17. 
Time points within these days are detailed in the schedule of assessments for each study 
part Appendix 4 (Part 1), Appendix 5 (Part 2) and Appendix 6 (Part 3). 
Baseline is defined as nominally the last measurement recorded prior to the first dose of 
IMP, for each dosing period.  
4 Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the safety and tolerability of single 
and multiple oral doses of MMV367 in healthy 
participants 
Incidence of adverse events (AEs), physical 
examination findings, and change from baseline for 
vital signs, electrocardiograms (ECGs) and 
laboratory safety tests. 
Secondary 
To assess the pharmacokinetics (PK) of single 
and multiple doses of MMV367 in plasma 
(Parts 1, 2 and 3) 
PK parameters such as AUC, Tmax, Cmax, CL/F, 
Vz/F, T1/2 and AR, when applicable 
To assess the effect of a high-fat meal on the 
PK of a single dose of MMV367 in healthy 
participants (Part 2 only) 
PK parameters such as AUC, Tmax, Cmax and Frel, 
as appropriate, under fed and fasted conditions 
Exploratory  
To assess the PK of single dose of MMV367 in 
urine (Part 1 only) of healthy participants 
(optional)a 
Urine PK parameters such as Ae, and derived 
plasma PK parameters such as CLr, when 
applicable 
To assess exposure response relationship for 
potential effects of MMV367 on ECG intervals 
(QT, QTcF, QTcB, PR, QRS)b 
ECG intervals, MMV367 plasma concentrations 
(time-matched) 
To investigate metabolite(s) of MMV367 in 
healthy participantsa 
Metabolite characterisation for MMV367 in plasma 
and urine, when applicable 
To evaluate the taste attributes (smell, 
sweetness, bitterness, flavour, 
mouthfeel/texture, grittiness and aftertaste) 
and overall acceptability of the IMP (Part 1 
only) 
Taste questionnaire score, based on a 9-point Likert 
scale assessing the acceptability for each taste 
attribute (smell, sweetness, bitterness, flavour, 
mouthfeel/texture, grittiness, and aftertaste) and 
overall acceptability for each dose level of MMV367 
a Depending on availability of the data, these objectives may be reported in an addendum to the final study 
Clinical Study Report (CSR) or in a separate report. 
b This objective will be reported in a separate cardiac safety report and will not be part of the final study CSR 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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5 Study Design 
5.1 
Brief Description 
The study is divided into Parts 1, 2 and 3. For each of the three parts, participants will be 
screened within 28 days prior to first admission to the clinical unit on the morning of 
Day -1. Each participant will receive verbal and written information followed by signing 
of the informed consent form (ICF) prior to any screening procedures taking place. 
5.1.1 Part 1 – Single Ascending Dose Cohorts 
Part 1 will be a double-blinded, randomised, placebo-controlled, SAD study, which will 
comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E will be optional), with 
8 participants in each cohort. Participants will be randomly assigned to receive a single 
oral dose of either active IMP (6 participants) or placebo (2 participants) to assess its 
safety, tolerability and PK profile. Each participant will take part in one cohort. The data 
obtained from each cohort (safety, tolerability and PK) will undergo a formal review by 
the safety advisory committee (SAC). The SAC will determine if it is safe and appropriate 
to proceed with the next dose/cohort. Following review of the emerging PK data from 
each preceding cohort, if results suggest that the exposure plateau has been reached, 
the next planned cohort will not be conducted. Similarly, if PK predictions suggest that 
this exposure plateau would be exceeded at the next cohort/dose level, a lower dose 
than originally anticipated will be proposed. 
It is planned to enrol 8 healthy male and female participants per cohort to ensure data in 
a minimum of 4 participants (per cohort) on active IMP. In each cohort, participants will 
be dosed on Day 1 and will remain resident in the clinical unit until discharge on Day 5. 
They will attend the clinical unit for a return visit on Day 7 and again on Day 15 (±1 day) 
for end of study assessments. Blood samples will be collected at regular intervals for PK 
analysis and safety from Day 1 to discharge from the study on Day 15 (±1 day), as 
detailed in Appendix 2. Each cohort will follow the same study design (Figure 1). 
Figure 1 
Study Sequence: Part 1 (Cohorts 1A to 1E) 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Dose 
Day 1 
 
Discharge 
Day 5  
 
Return Visit  
Day 7 
 
End of Study Visit 
Day 15 (±1 day) 
Each participant will take part in one cohort and will receive one of the regimens 
presented in Table 1, according to the randomisation schedule. 
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There will be a blinded interim review of the safety, tolerability and PK data after each 
cohort prior to the dose decision for subsequent cohorts. Full details of the interim data 
reviews are provided in Section 5.2. 
Participants will also complete a written taste/palatability questionnaire individually and 
privately following administration of the IMP. In the evening of Day -1, participants will be 
trained to respond to a sample questionnaire using a suitable example fluid (e.g., orange 
juice/squash). On the morning of Day 1, participants will brush their teeth using tap water 
(toothpaste not permitted). In order to evaluate taste, participants will hold the IMP in 
their mouth and swirl it around for 10 to 15 sec before swallowing. Immediately after 
swallowing, they will complete a taste questionnaire individually and privately. 
5.1.2 Part 2 – Food Effect Cohort 
Part 2 will be an open-label, randomised, balanced two-period crossover, food effect 
evaluation. The effect of food on the PK of MMV367 will be explored in Part 2 by 
administering a single dose of MMV367 after a high-fat breakfast, as per FDA guidance, 
and a single dose of MMV367 in the fasted state. 
Each participant will receive 2 single doses of MMV367. In Period 1, participants will be 
randomised 
to 
1 
of 
2 
treatment 
sequences 
(Regimen 
6/Regimen 
7 
or 
Regimen 7/Regimen 6). If a participant is randomised to receive MMV367 in the fasted 
state (Regimen 6) in Period 1, they will receive MMV367 in the fed state (Regimen 7) in 
Period 2 and vice versa. It is planned to enrol 8 healthy male and female participants to 
ensure data in a minimum of 6 participants.  
Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and 
will remain resident in the clinical unit until discharge on Day 12. They will attend the 
clinical unit on Day 14 (±1 day) for end of study assessments. Based on emerging PK 
data from Part 1, the washout period between the Period 1 and Period 2 doses may be 
extended. Blood samples will be collected at regular intervals for PK analysis and safety 
from Day 1 to the end of study visit on Day 14 (±1 day), as detailed in Appendix 3. The 
study design for Part 2 is presented in Figure 2. 
Figure 2 
Study Sequence: Part 2 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Period 1 Dose 
Day 1 
 
Period 2 Dose 
Day 8 
 
Discharge 
Day 12 
 
End of Study Visit 
Day 14 (±1 day) 
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Each participant will receive Regimens 6 and 7, presented in Table 2. 
5.1.3 Part 3 – Multiple Dose Cohort(s) 
Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A 
total of 8 participants per cohort will receive once-daily doses of MMV367 (6 participants) 
or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability 
and PK profile of multiple dosing.  
It is planned to enrol 8 healthy male and female participants to ensure data in a minimum 
of 4 participants on active IMP.  
Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the 
clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on 
Day 9 and again on Day 17 (±1 day) for end of study assessments. Blood samples will 
be collected at regular intervals for PK analysis and safety from Day 1 to discharge from 
the study on Day 17 (±1 day), as detailed in Appendix 4. Each cohort will follow the same 
study design (Figure 3). 
Figure 3 
Study Sequence: Part 3 (Cohorts 3A to 3C) 
Screening 
Day -28 to Day -2 
 
Admission 
Day -1 
 
Dose 
Days 1, 2 and 3 
 
Discharge 
Day 7  
 
Return Visit  
Day 9 
 
End of Study Visit 
Day 17 (±1 day) 
 
Each participant will receive one of the regimen(s) presented in Table 3 according to the 
randomisation schedule. 
During the interim review of each cohort within Part 1, if it is determined that the optimal 
dose has been identified for the assessment of food effect,  Part 2, may commence prior 
to the completion of Part 1, provided that this is justified by PK and safety data obtained 
from completed cohorts in Part 1. Similarly, Part 3 may commence prior to the completion 
of Part 1 if the required dose level is identified during interim review. However, the total 
amount of active IMP administered as multiple doses (i.e., cumulative 3-day dose) in 
Part 3 will be no greater than the maximum safe and well tolerated dose identified Part 
1, dosed at a single dose level. Parts 2 and 3 may be conducted in parallel. 
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The data obtained (safety and PK) from the multiple dose administration will undergo a 
formal review by the SAC after all 8 participants have completed the study. 
Consequently, Part 3 may be extended to evaluate a second and/or third dose level in a 
3-day QD regimen. 
Parts 1 and 3 will follow a sentinel dosing design. On the first day of dosing in each cohort 
in Part 1 and in Part 3, only 2 (sentinel) participants will be dosed. The randomisation 
schedule will be constructed such that 1 of the participants dosed on the first day will 
receive MMV367 and 1 will receive placebo. After review of the safety data up to 96 h 
post-dose for SAD cohorts in Part 1 and up to 96 h post-final dose in Part 3, the 
investigator, or medically qualified designee who is familiar with the study protocol and 
IB, and medical monitor or delegate (with approval from the sponsor’s medical director 
or delegate) will decide whether to proceed with dosing the remaining participants in the 
cohort. 
5.2 
Criteria for In-Study Decisions 
In-study decisions will be made by the safety advisory committee (SAC), which will 
always comprise the investigator, the medical monitor, the sponsor’s medical director, 
and PK, together with appropriate representation from the partner organisation 
(GlaxoSmithKline plc [GSK]) where appropriate. 
5.2.1 Decision Points  
The following in-study decisions will be made during this study: 
• 
Dose selection for Cohorts 1B to 1E in Part 1 
• 
Progression from Cohort 1D to 1E in Part 1 
• 
Washout period duration between periods in Part 2 
• 
Dose selection for Parts 2 and 3 
• 
Changes to safety and/or PK time points, if there is reason to believe that the 
change might improve the quality of the data as a consequence of review of 
emerging data 
• 
Progression from Cohort 3A to further multiple dose levels in Part 3  
5.2.2 Criteria for Dose Decision 
Part 1: Single Ascending Dose Cohorts 1A to 1E 
Progression to the next dose cohort will be permitted after review of safety, tolerability 
and PK data suggests that it is safe to do so. Quotient will provide data to the SAC in 
accordance with Quotient’s standard operating procedure (SOP) on interim dose 
decision making and dose escalation. The decision will be documented and signed by 
the investigator as per Quotient’s current SOP. Evidence of the decision will be retained 
in the ISF and Trial Master File. 
For dose escalation to proceed, data must be available from a minimum of 6 participants 
who have completed the planned safety assessments up to 7 days after dosing and 
planned PK assessments up to 144 h after dosing to ensure at least 4 participants had 
received active IMP. Dose increases will only be made after a complete review of all data 
collected from the previous dose group by the SAC.  
It is planned that the dose will be escalated for each subsequent cohort; however, the 
SAC may also agree to enrol additional participants for an intermediate dose level if 
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warranted or may agree to reduce the dose with no limit on the possible extent of 
reduction. Any decision to investigate an intermediate or reduced dose level will be fully 
documented. 
The decision to proceed to the next dose level will be based on safety, tolerability and 
available PK data. The following data are required: 
• 
AEs 
• 
Vital signs 
• 
Safety laboratory results 
• 
ECGs 
• 
Physical examination findings 
• 
Plasma concentrations of MMV367 
• 
Interim PK parameter estimations (Tmax, Cmax, AUC(0-24), AUC(0-48), 
AUC(0last), AUC(0-inf), T1/2, where possible and appropriate) 
Rules for dose decision are as follows: 
• 
Dose increments between SAD cohorts will be a maximum of 3-fold and dose 
escalation may be halted in the SAD cohorts if an exposure plateau appears to 
have been reached 
• 
Dose increments between multiple dose optional cohorts will be no more than 3-
fold 
• 
No dose selected for SAD or MAD will be expected to result in a mean group 
exposure at the next dose level (based on predicted human PK and assuming dose 
linearity) greater than AUC(0-inf) 376 µg.h/mL, and Cmax 23.8 µg/mL based on the 
NOAEL in dogs and the corresponding human therapeutic exposure 
• 
The predicted exposure (AUC(0-inf)) of the cumulative dose after a 3-day treatment 
will not exceed that of a single dose evaluated in Part 1 which is safe and well 
tolerated 
• 
The study will be halted (see Section 8.5 of the study protocol) and thus a further 
dose decision will not be made if: 
− One or more participants experience an IMP-related serious AEs (SAE) 
− Two or more participants experience an IMP-related severe or clinically 
significant non-serious AE at the same dose level/same cohort 
If, following review by the SAC it is deemed acceptable to continue dose escalation 
above the defined maximal dose or exposure limit, a substantial amendment with 
relevant data will be submitted for approval to the Medicines and Healthcare products 
Regulatory Agency (MHRA) and ethics committee (EC). 
Progression from Part 1 (SAD) to Part 2 (Food Effect).  
For the dose level decision to be made for Part 2, data must be available from a minimum 
of 6 participants who have completed the planned safety assessments up to 7 days after 
dosing and planned PK assessments up to 144 h after dosing (to ensure at least 
4 participants had received active IMP), at a relevant dose level in Part 1. A “relevant 
dose level” is defined as a dose that demonstrated acceptable safety/tolerability 
(i.e., exposure levels at which no study specific criteria stopping dose progression and/or 
escalation were met) at a mean exposure that is not anticipated to be exceeded by the 
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dosing regimen in Part 2, taking into account a potential bioavailability increase to 100% 
after a high-fat breakfast. 
Progression from Part 1 (SAD) to Part 3 (Multiple Dose).  
For the dose level decision to be made for Part 3, data must be available from a minimum 
of 6 participants who have completed the planned safety assessments up to 7 days after 
dosing and planned PK assessments up to 144 h after the final dose (to ensure at least 
4 participants had received active IMP), at a relevant dose level in Part 1. The total dose 
in Part 3 (3 × QD dose) will not exceed a dose of MMV367 administered and evaluated 
as a single dose in Part 1, and the predicted exposure will not exceed an exposure 
observed and determined to be safe in Part 1. If a less than dose-proportional increase 
in exposure is observed in Part 1 (SAD), the proposed dose(s) for Part 3 may be adjusted 
to ensure the equivalent exposures between SAD and MAD. 
8.2.1 Criteria for Sentinel Dosing Decisions 
For all cohorts following a sentinel design (Parts 1 and 3) the decision to proceed with 
the main group will be made by the investigator, based on safety data until 96 h postdose 
(Part 1) or 96 h post-final dose (Part 3) in the sentinel participants. The investigator or 
medically qualified designee who is familiar with the study protocol and IB, and medical 
monitor or delegate (with approval from the sponsor’s medical director or delegate) will 
decide whether to proceed with dosing the remaining participants in the cohort.  
5.3 
Study Sample Size 
For Parts 1 and 3, the primary objective is an initial assessment of safety and each 
treatment group is therefore limited to 6 participants receiving active IMP. Administration 
of MMV367 to 6 participants at each dose level provides a 47%, 62%, 74%, or 82% 
probability of observing at least 1 occurrence of any AE, with a true incidence rate for a 
given dose group of 10%, 15%, 20%, or 25%, respectively. 
Furthermore, it is assumed that pooling the data for the 2 participants who receive 
placebo in each cohort will provide an adequately sized control group to assess a 
possible drug effect on safety laboratory tests, vitals and ECG parameters. 
Part 2 is a pilot evaluation designed to determine whether MMV367 PK is impacted by 
high-fat food. Historically, 8 participants have proven sufficient to characterise the 
preliminary effects of food on safety and PK of a new chemical entity in healthy 
participants. Therefore, a sample size of 8 is considered adequate at this stage of drug 
development. 
5.4 
Randomisation (including Replacement Subjects) 
Parts 1 and 3 will be randomised (IMP/placebo) and double-blinded. Part 2 will be 
randomised (fed/fasted) and open-label. A randomisation schedule will be produced for 
each study part. Instructions to dispense and dose will be produced prior to dosing using 
the randomisation schedule and will be retained in the ISF. 
For Part 2, the original randomisation schedule and proof of quality control procedures will 
be held by the Data Sciences department at Quotient until the study is archived, at which 
time the randomisation materials will be retained in the ISF. 
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Using computer-generated randomisation schedules, participant numbers will be 
allocated to treatment regimens in a 6:2 ratio (MMV367:placebo) in each cohort (Part 1 
or Part 3). In Part 2, the allocation will be balanced with 8 participants assigned to receive 
MMV367 in both the fed and fasted states. Participants will be randomised to 1 of 2 
treatment sequences (Regimen 6/Regimen 7 or Regimen 7/Regimen 6) on Day 1 prior 
to dosing in the first period. 
For participants in Parts 1 and 3, a sentinel group of 2 participants will be dosed ahead 
of the remaining participants in each cohort. For each cohort, using a 
computer‑generated randomisation schedule, the first 2 participant numbers will be 
allocated to active or placebo in a 1:1 ratio (i.e., 1 participant will be randomly assigned 
to receive MMV367 and 1 participant will be randomly assigned to receive placebo). The 
remaining 6 participant numbers will be allocated to active or placebo in a 5:1 ratio 
(i.e., 5 participants will be randomly assigned to receive MMV367 and 1 participant will 
be randomly assigned to receive placebo). 
Participants will be randomised immediately before administration of the first dose. 
5.4.1 Participant Numbers 
Participant numbers will be allocated on the morning of dosing according to the code 101 
to 140 in Part 1, 201 to 208 in Part 2, and 301 to 324 in Part 3 using the lowest number 
available. Replacement participants will be allocated participant numbers 901 to 940 in 
Part 1, 801 to 808 in Part 2 and 701 to 724 in Part 3, where the last two digits are the 
same as those of the original participant (e.g., if Participant 105 withdraws, the 
replacement will have Participant Number 905 and will receive the same regimen as 
Participant 105).  
In Part 1, up to 2 replacement participants may be used per cohort. The maximum 
number of participants that may be dosed is 50 (8+2 per cohort). In Part 2, up to 4 
replacement participants may be enrolled into the study. The maximum number of 
participants that may be dosed in Part 2 is 12 (8+4). In Part 3, up to 2 replacement 
participants per cohort (if optional cohorts are utilised) may be enrolled into the study. 
The maximum number of participants that may be dosed is 30 (8+2 per cohort). 
Any participant withdrawn due to an IMP related AE will not be replaced. 
Participants withdrawing for other reasons may be replaced as required by agreement 
between the investigator and sponsor to ensure sufficient evaluable participants. 
Participant numbering by study part and cohort is provided in Table 4. 
Table 4 
Participant Numbers 
Study Part 
Cohort 
Participant Numbers 
1 
1A 
101–108 
1B 
109–116 
1C 
117–124 
1D 
125–132 
1E (optional) 
133–140 
2 
2A 
201–208 
3 
3A 
301–308 
3B (optional) 
309–316 
3C (optional) 
317–324 
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5.5 
Blinding Issues 
Parts 1 and 3 of the study are double-blinded. Treatment assignment will not be known 
to the participants, the sponsor or the staff who are involved in the clinical evaluation of 
the participants and the analysis of data. If appearance matching of the placebo is not 
possible then masking and/or unblinded dosing teams will be used to preserve the study 
blind. Further details of these steps will be contained in the study specific blinding plan, 
which will be approved prior to dosing. The randomisation schedules and disclosure 
envelopes will be generated by an unblinded statistician at Quotient according to 
Quotient’s SOPs. The unblinded statistician will not be involved in any decisions relating 
to populations for analysis prior to unblinding. Prior to database lock and unblinding, all 
original randomisation materials, including the original final signed and dated 
randomisation schedule, will be held by the Quality Assurance (QA) department at 
Quotient. The Data Sciences department will not have access to the randomisation 
schedule before database lock and unblinding.  
Interim PK parameter estimations will be performed using bioanalytical data applied with 
participant aliases in order to maintain the study blind.  
There may be instances where interim PK data have the potential to be treatment 
revealing e.g., missed blood sampling occasions. In these cases, every effort will be 
made by the pharmacokineticist to maintain the study blind by appropriate presentation 
of data to the study team. Data demonstrating extremes of exposure will always be 
presented, regardless of the potential to reveal the study blind. To permit selection of the 
dose level, individual data may be made available in full if judged necessary by the 
investigator or sponsor regardless of the potential to reveal study blind. 
The unblinded Qualified Person or designee at the clinical site will receive a copy of the 
final randomisation schedule for preparation of the study drug and preparation of the 
instructions to dispense and dose. A copy of the randomisation schedule will also be 
made available to the laboratory performing the bioanalysis to allow selective analysis of 
drug concentrations (for Parts 1 and 3) and to the pharmacovigilance provider for 
analysis of pharmacovigilance. 
Two sets of disclosure envelopes (i.e., sealed envelopes containing individual participant 
randomisation details) will be provided. One set will be held in the clinical area and the 
other retained in the ISF. These may be used in the event of an emergency by the 
investigator or delegate. Any request for information on the randomisation schedule after 
initial issue must be made using a randomisation disclosure form, except in the case of 
emergency unblinding, which must be recorded on the emergency unblinding form. 
Access to study drug assignment will be immediately available if the investigator deems 
it necessary to break the study blind in the interest of a participant’s medical safety, in 
case of a medical emergency, or if warranted during scheduled safety reviews. The 
medical monitor must be contacted within 24 h following disclosure of study drug 
assignment.  
Details of any disclosure of the randomisation schedule will be documented and retained 
in the ISF. The sponsor will be notified if the study blind is broken.  
Part 2 of the study is open-label and therefore blinding is not required. 
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5.6 
Unblinding procedures 
The study blind will be broken after the study database has been locked and the safety 
population has been defined. Any subsequent request for issue of the randomisation 
schedule prior to unblinding must be made using a randomisation disclosure form. 
5.7 
Maintaining the Blind During Interim PK Analyses 
The interim PK analysis/analyses in Part 1 and Part 3 will be performed on QC checked 
concentration data for MMV367 in plasma using nominal sampling times and doses. Data 
will be received with participant aliases applied to the concentration data in order to 
maintain the study blind. 
There may be instances where interim data has the potential to be treatment revealing 
eg missed blood sampling occasions. In this case every effort will be made by the 
pharmacokineticist to maintain the study blind by appropriate restriction/modification of 
data presented to the study team, such as only presenting the summary statistics e.g., 
mean, SD, minimum, median, maximum, geometric mean and geometric CV% for both 
PK parameters and concentration data. 
Data demonstrating extremes of exposure will always be presented, regardless of the 
potential to reveal the study blind. Further details can be found in the blinding plan. 
6 Populations and Analysis Sets 
6.1 
Safety Population and Safety Analysis Set 
The safety population and safety analysis sets will be defined separately for each study 
part. 
The safety population will include all subjects who have received any amount of IMP.  
The safety analysis set will be defined on a treatment basis and will include all safety 
data from the subjects included in the safety population who have received that 
treatment. 
The safety population will be confirmed by Quotient with approval from MMV after 
database lock (Part 2) and prior to unblinding (Part 1 and Part 3) and will be summarised 
for the populations table and to determine the subjects to be included in the safety 
analysis set.  
The safety analysis set will be confirmed by Quotient with approval from MMV at the 
same time as the relevant safety population and will be summarised for the analysis of 
demographic and baseline characteristics, and all safety data. 
6.2 
Taste Population and Taste Analysis Set 
The taste population will include all subjects who have received at least one regimen 
(i.e., active dose or placebo), in Part 1, and held it in their mouth for approximately 10 to 
15 seconds. Participants will have also completed the taste questionnaire for a regimen 
and have no relevant protocol deviations for any taste test or AEs which confound the 
taste assessment. 
The taste population will be determined by Quotient with approval from MMV after 
database lock and will be used for the taste tables and to determine the participants to 
be included in the taste analysis set.  
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The taste analysis set will be defined on a regimen basis and will include all relevant data 
from the participants included in the taste population who have received that test product.  
The taste analysis set will be determined by Quotient with approval from MMV at the 
same time as the taste population and will be used for all summary tables and formal 
statistical analysis of taste data.  
6.3 
Pharmacokinetic Population and Pharmacokinetic Analysis Set(s) 
The PK population will be defined separately for study Parts 1, 2 and 3 and will include 
all subjects who have received at least one dose of IMP and who satisfy the following 
criteria for at least one profile: 
• 
No missing samples or invalid post-dose analytical results at critical time points 
e.g., around Cmax 
• 
No relevant protocol deviations that may impact the study objectives with respect to 
the PK endpoints 
• 
No relevant AEs such as vomiting that suggest that the whole dose was not 
available for absorption for a particular participant  
Handling of the urine concentration data is not currently a planned analysis in the CSR; 
however, should a validated method be developed and the urine concentrations be 
required to be reported by Quotient in Part 1, then the following should apply to the 
processing of the urine data. Any protocol deviations or AEs specific to the analysis of 
urinary PK parameters will be documented as an update to the PK population when urine 
data are available for analysis. Subjects who received placebo in Part 1 and 3 will not be 
included in the PK population. 
The PK analysis set will be defined on a per-treatment basis and will include all relevant 
data from the subjects included in the PK population who have received that treatment. 
In Part 1, individual subjects will be excluded from the PK analysis set where deemed 
appropriate such as if the participant’s data for the treatment affected did not meet the 
bullet point criteria above, or other study emergent point related to PK analysis or 
interpretation. 
In Part 2, individual participant profiles (i.e., treatments) will be excluded from the PK 
analysis set where deemed appropriate such as if the participant’s data for the treatment 
affected did not meet the bullet point criteria above, or other study emergent point related 
to PK analysis or interpretation. 
In Part 3, individual subjects will be excluded from the PK analysis set where deemed 
appropriate such as if the participant’s data for the treatment affected did not meet the 
bullet point criteria above for at least one individual profile (i.e., day), or other study 
emergent point related to PK analysis or interpretation. 
Individual participant profiles in Part 3 (i.e., days) will be flagged and excluded from the 
PK summary statistics where deemed appropriate such as if the profile in the day 
affected did not meet the bullet point criteria above, or other study emergent point related 
to PK analysis or interpretation. 
The PK population and analysis set will be confirmed by Quotient with approval from 
MMV following derivation of all PK parameter estimates. 
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If required, a PK analysis subset(s) will also be documented by Quotient, with approval 
from MMV, at the same time as the PK population and analysis set, if additional subjects 
are required to be excluded from the statistical analysis (i.e., to exclude subjects who 
have not received both the fed and fasted treatments in Part 2).  
All enrolled subjects will be used for the PK data listings. The PK population will be used 
for the populations table. The PK analysis set and/or the PK analysis subset(s), if 
defined, will be used for the provision of PK summary tables and figures as well as the 
formal statistical analysis and will be documented as the same time as the PK population. 
7 Participant 
Disposition, 
Demographics 
and 
Baseline 
Characteristics 
No formal statistical testing will be performed on participant disposition, or on 
demographic or baseline data. Summaries of participant disposition and analyses 
populations will be based on all enrolled subjects and summaries of all other data 
described in this section will be based on the safety analysis set unless otherwise stated. 
7.1 
Screening Failures 
For each study part, data for subjects who have failed screening will be databased but 
will not be cleaned and therefore will not be included in the SDTM or ADaM datasets or 
any of the TFLs or the CSR. 
7.2 
Participant Disposition and Withdrawals 
For each study part, the number and percentage of subjects randomised, dosed, 
completed and discontinued will be presented by sequence and overall in Part 2, and by 
all placebo, all active and each dose level in Part 1 and Part 3. If any subjects 
discontinued from the study early then the number of subjects for each reason for 
discontinuation will be presented by sequence and overall in Part 2, and by all placebo, 
all active and each dose level in Part 1 and Part 3. However, if none of the subjects are 
discontinued from the study early, then the reasons for discontinuation will not be 
populated in the summary table. A participant may be discontinued from the study early 
for 1 reason only. 
Participant disposition and withdrawal data  will be listed including details of informed 
consent. 
Protocol deviations and any violations of the inclusion/exclusion criteria will also be listed. 
7.3 
Analysis Populations 
A summary table will be produced detailing the number and percentage of subjects in 
each population (i.e., safety/taste/PK, as applicable) by sequence and overall in Part 2, 
and by all placebo, all active and each dose level in Part 1 and Part 3. The reasons for 
exclusion from each population will also be included in the summary table. However, if 
none of the subjects were excluded from a population, then the reasons for exclusion 
will not be populated in the summary table. A participant may be excluded from a 
population for more than 1 reason. The denominator for the percentage is the number of 
subjects enrolled in the respective sequence in Part 2, and the number of subjects 
enrolled in Part 1 and Part 3. 
Details of subjects included and excluded in the different analysis populations will be 
listed. 
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7.4 
Analysis Sets and Subsets 
A summary table will be produced detailing the number and percentage of subjects in 
each of the safety, taste and PK analysis sets and analysis subsets (if applicable) for 
each treatment and overall in Part 2, and by all placebo, all active and each dose level 
in Part 1 and Part 3. Separate tables will be presented for safety, taste and PK, analysis 
sets and each table will be based on the relevant population the analysis set is derived 
from. If analysis subsets are defined they will be included on the same table as the 
corresponding analysis set. The reasons for exclusion from each analysis set/subset will 
also be included in the summary. However, if none of the subjects were excluded from 
an analysis set, then the reasons for exclusion will not be populated in the summary 
table. A participant may be excluded from an analysis set for more than 1 reason. The 
denominator for the percentage is the number of subjects in each population. 
Details of subjects included and excluded in the different analysis sets/subsets will be 
listed. 
7.5 
Demographic Characteristics and Lifestyle Details 
Demographic data (age, ethnicity, race, sex, height [cm], weight [kg] and body mass 
index [BMI; kg/m2]) will be recorded at screening. 
Summary statistics (number of subjects with an observation [n], mean, standard 
deviation [SD], median, minimum and maximum) will be presented for age, height, weight 
and BMI at screening by sequence and overall in Part 2, and by all placebo, all active 
and each dose level in Part 1 and Part 3. The number and percentage of subjects will be 
presented by sequence and overall in Part 2, and by all placebo, all active and each dose 
level in Part 1 and Part 3 for ethnicity, race and sex. The denominator for the percentage 
is all subjects in the safety analysis set. If any values are missing, a “missing” row will be 
presented on the table. 
Lifestyle details (i.e., smoking history [does the participant smoke, use e-cigarettes or 
use nicotine replacement products?] and alcohol consumption) will be summarised by 
sequence and overall in Part 2, and by all placebo, all active and each dose level in 
Part 1 and Part 3, as a categorical variable. 
Demographic and lifestyle data for all enrolled subjects will be listed. For Part 2 only, 
separate columns will be provided in the demographic listing for body weight at screening 
and admission. 
7.6 
Medical History 
Medical history will be recorded for each participant at the screening visit and updated 
at admission. Medical histories will be coded using MedDRA v25.0 (or a more recent 
version) including Lowest Level Term, Preferred Term (PT), and System Organ Class 
(SOC).  
All medical history data will be listed including coded terms. 
7.7 
Prior and Concomitant Medication 
Medications (product name) will be coded using the World Health Organization (WHO) 
Drug Dictionary Global Drug Reference version 2022 March (or more recent version) 
using the following Anatomical Therapeutic Chemical (ATC) classification codes 
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• 
Product name 
• 
Preferred name  
• 
Drug code 
• 
Therapeutic subgroup (ATC 2nd level code) 
• 
Chemical subgroup (ATC 4th level code) 
Prior medications are defined as medications that start and stop prior to the first dose of 
IMP. All other medications will be defined as concomitant medications including those 
that start prior to the first dose of IMP and continue thereafter. Any medications with an 
unknown start or stop date will be assumed to be concomitant medications unless a 
partial start or stop date indicates otherwise. 
All medications, including coded terms, and the underlying indication for which the 
medication was given, will be listed. One combined data listing of prior and concomitant 
medications will be provided. All prior medications as defined above will be flagged with 
a “#” symbol. Within this flagged group medications that started after screening and 
stopped before dosing of IMP will also be flagged using a “*” symbol. 
7.8 
Other Baseline Characteristics 
All other baseline characteristics, as listed below, at screening and on admission (unless 
otherwise stated) will be listed separately for each study part: 
• 
Carbon monoxide breath test 
• 
Urine drug screen 
• 
Alcohol breath test 
• 
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Antigen test 
• 
Beck Depression Inventory (BDI-II) Questionnaire  
• 
Virology (Screening only) 
• 
Creatinine clearance (Admission only) 
• 
Follicle stimulating hormone for female subjects (Screening only) 
• 
Serum pregnancy test for female subjects (Screening only) 
• 
Urine pregnancy test (Admission only) 
8 Efficacy 
Not applicable for this Phase I study.  
9 Pharmacokinetics 
9.1 
Plasma PK Parameter Estimation  
The PK parameters (Table 5 [Part 1 and 2], Table 6 [ Part 3]) for MMV367 in plasma will 
be estimated where possible and appropriate for each participant profile (i.e., 
treatment/day [where relevant]) by non-compartmental analysis methods using Phoenix 
WinNonlin software (v8.3 or a more recent version, Certara USA, Inc., USA). Additional 
parameters may be calculated if required, depending on the data. 
9.1.1 Definition of Plasma PK Parameters 
Plasma PK parameter definitions are provided in Table 5 and Table 6. 
Table 5 
Plasma PK Parameter Definitions and Rounding Specifications – Part 1 
and 2 
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Parameter 
Definition 
Unit 
DP 
or SF 
No. of 
DP/SF 
Tmax 
Time of maximum observed 
concentration 
h 
DP 
2 
Cmax 
Maximum observed concentration 
mass unit/mL 
SF 
3 
AUC(0-24) 
Area under the curve from time 0 to 
24 h post dose 
mass 
unit.h/mL 
SF 
3 
AUC(0-48) 
Area under the curve from time 0 to 
48 h post dose 
mass 
unit.h/mL 
SF 
3 
AUC(0-72) 
Area under the curve from time 0 to 
72 h post dose 
mass 
unit.h/mL 
SF 
3 
AUC(0-last) 
Area under the curve from time 0 to 
the time of last measurable 
concentration 
mass 
unit.h/mL 
SF 
3 
AUC(0-inf) 
Area under the curve from time 0 
extrapolated to infinity  
mass 
unit.h/mL 
SF 
3 
AUCextrap 
Area under the curve (AUC) from 
time of the last measurable 
concentration to infinity as a 
percentage of the area under the 
curve extrapolated to infinity 
% 
DP 
2 
T1/2  
Terminal elimination half-life 
h 
DP 
2 
lambda-z 
First order rate constant associated 
with the terminal (log-linear) portion 
of the curve 
1/h 
DP 
4 
CL/F 
Total apparent body clearance 
calculated after a single 
extravascular administration where 
F (fraction of dose bioavailable) is 
unknown.  
mL/min 
SF 
3 
CLra 
Renal clearance calculated using 
plasma AUC – Part 1 only 
mL/min 
SF 
3 
Vz/F 
Apparent volume of distribution 
based on the terminal phase 
calculated using AUC(0-inf) after a 
single extravascular administration 
where F (fraction of dose 
bioavailable) is unknown 
L 
SF 
3 
Frel Cmax 
Relative bioavailability based on 
Cmax (Part 2 fed dosing only) 
% 
DP 
2 
Frel AUC(0-last) 
Relative bioavailability based on 
AUC(0-last) (Part 2 fed dosing only) 
% 
DP 
2 
Frel AUC(0-inf) 
Relative bioavailability based on 
AUC(0-inf) (Part 2 fed dosing only) 
% 
DP 
2 
lambda-z lower* 
Lower limit on time for values to be 
included in the calculation of 
lambda-z 
h 
DP 
2 
lambda-z upper* 
Upper limit on time for values to be 
included in the calculation of 
lambda-z 
h 
DP 
2 
 
DP: decimal places;  NA: not applicable; SF: significant figures 
* these values should be listed but omitted from the descriptive statistics 
a Renal clearance will only be calculated in Part 1 should a validated method be developed, and the urine 
concentrations be required to be reported by Quotient, as an addendum to the CSR 
Table 6 
Plasma PK Parameter Definitions and Rounding Specifications – Part 3 
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Parameter 
Definition 
Unit 
DP or 
SF 
No. of 
DP/SF 
Tmax 
Time of maximum observed 
concentration 
h 
DP 
2 
Cmax 
Maximum observed concentration 
mass unit/mL 
SF 
3 
AUC(0-tau) 
Area under the curve for the defined 
interval between doses (tau) 
mass unit.h/mL 
SF 
3 
T1/2  
Terminal elimination half-life (Day 3 
only) 
h 
DP 
2 
lambda-z 
First order rate constant associated 
with the terminal (log-linear) portion of 
the curve (Day 3 only) 
1/h 
DP 
4 
CL/Ftau 
Total body clearance calculated using 
AUC(0-tau) after repeated 
extravascular administration, where F 
(fraction of dose bioavailable) is 
unknown (Day 3 only) 
mL/min 
SF 
3 
Vz/Ftau 
Apparent volume of distribution based 
on the terminal phase calculated using 
AUC(0-tau) after extravascular 
administration where F (fraction of 
dose bioavailable) is unknown (Day 3 
only) 
L 
SF 
3 
AR Cmax 
Accumulation ratio based on Cmax 
repeated dose/Cmax single dose (Day 
3 only) 
NA 
DP 
2 
AR AUC 
Accumulation ratio based on 
AUC(0-tau) repeated dose/AUC(0-tau) 
single dose (Day 3 only) 
NA 
DP 
2 
lambda-z lower* 
Lower limit on time for values to be 
included in the calculation of lambda-z 
(Day 3 only) 
h 
DP 
2 
lambda-z upper* 
Upper limit on time for values to be 
included in the calculation of lambda-z 
(Day 3 only) 
h 
DP 
2 
DP: decimal places;  NA: not applicable; SF: significant figures 
* these values should be listed but omitted from the descriptive statistics 
Dose will be used in the calculation of relevant PK parameters as per Table 7. 
Table 7 
Dose Specifications 
Dose (nominal/actual) 
Nominal  
Precision 
As per protocol 
In Part 2, relative bioavailability (Frel) will be calculated as follows: 
Frel = {
AUC or Cmax (test)
AUC or Cmax (reference)} × 100 
Frel will be calculated using Cmax, AUC(0-last) and AUC(0-inf). If for any reason the 
AUC(0-inf) is not calculable then an alternative or additional AUC over a partial area may 
be used to calculate Frel for all subjects. 
The following comparisons will be made: 
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• 
XX mg MMV367 fed [Regimen 7] (test) vs XX mg MMV367 fasted [Regimen 6] 
(reference) 
Renal clearance (CLr) is a plasma parameter and will be calculated as follows in 
Part 1, if applicable: 
CLr = Ae
AUC 
where both amount excreted (Ae) of parent in urine and AUC of parent in plasma are 
determined over co-incident time ranges after dosing. For example, if urinary Ae is 
calculated over 0-24 hours then the plasma AUC used will also be calculated over the 
same period. Details of methods for calculation of CumAe are included in Section 9.2. 
9.1.2 Rules for Plasma PK Parameter Estimation using WinNonlin 
The imputation of non-numerical (e.g., below the limit of quantification [BLQ]) or negative 
values (e.g., pre-dose sampling times) reported in the input data set will be performed 
as follows for calculation of PK parameters: 
• 
Pre-dose sample times will be entered as zero 
• 
Values that are BLQ obtained prior to Cmax will be entered as zero 
• 
Values that are BLQ after Cmax will be treated as missing but where BLQ 
concentrations are defined as parameters these will be reported as BLQ 
• 
Values that are BLQ after Cmax may be imputed as zero for the calculation of 
partial AUCs, in cases where lambda-z cannot be determined 
• 
Values that are measurable after at least 2 consecutive BLQ values after Cmax will 
be treated as missing for the calculation of PK parameters 
• 
Values that are reported as “No Result” or “Not Reportable” (NR), “Not Calculated” 
(NC) or “No Sample” (NS) etc. will be generally be considered missing 
Missing or unusual concentration values in the input data may be queried to ascertain 
any underlying cause. Exclusion of missing or unusual concentration values, or repeat 
bioanalysis of samples, will only be performed if a definitive root cause can be 
established and approval from MMV has been obtained. Any exclusions of concentration 
values or repeat analysis of samples will be documented appropriately.  
 
 
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Plasma PK parameters will be estimated using standard Phoenix WinNonlin methods, 
details of which may be found in the documentation accompanying the WinNonlin 
software package. The rules specified in Table 8 will be applied: 
Table 8 
PK Parameter Estimation Details 
Sampling times 
Actual 
Calculation method 
Linear Log Trapezoidal  
Number of points used for lambda-z 
At least 3, not including Cmax 
Minimum requirements for AUC  
At least 3 consecutive measurable concentrations 
 
Where possible, the terminal elimination rate constant (lambda-z) will be calculated for 
all participant profiles. The value of lambda-z will be determined by the slope of the 
regression line of the natural log transformed concentrations vs time.  
The WinNonlin determined choice of data points for determination of lambda-z will be 
reviewed by the pharmacokineticist who may adjust the selection in order to provide a 
more appropriate fit. The choice of data points for determination of lambda-z for each 
profile will be confirmed following a documented peer review.  
9.1.3 Plasma PK Parameter Reporting Specifications 
The following parameters will be reported for each Study Part/Study Treatment/Study 
Day as applicable, according to the rounding specifications provided in Table 5 and Table 
6: 
Part 1  
Tmax, Cmax, AUC(0-24), AUC(0-48), AUC(0-last), AUC(0-inf), AUCextrap, T1/2, 
lambda-z, CL/F, CLr*, Vz/F, lambda-z lower, lambda-z upper 
Part 2 – fasted  
Tmax, Cmax, AUC(0-24), AUC(0-48), AUC(0-last), AUC(0-inf), AUCextrap, T1/2, 
lambda-z, CL/F, Vz/F, lambda-z lower, lambda-z upper 
Part 2 – fed  
Tmax, Cmax, AUC(0-24), AUC(0-48), AUC(0-last), AUC(0-inf), AUCextrap, T1/2, 
lambda-z, CL/F, Vz/F, Frel Cmax, Frel AUC(0-last), Frel AUC(0-inf), lambda-z lower, 
lambda-z upper 
Part 3, Day 1 
Tmax, Cmax, AUC(0-tau) 
Part 3, Day 3 
Tmax, Cmax, AUC(0-tau), T1/2, lambda-z, CL/Ftau, Vz/Ftau, AR Cmax, AR AUC, 
lambda-z lower, lambda-z upper  
* Renal clearance will only be calculated in Part 1 should a validated method be developed, and the urine 
concentrations be required to be reported by Quotient, as an addendum to the CSR 
The flags/footnotes given in Table 9 will be applied to the PK parameters where relevant 
and will be shown in the PK parameter listings. Additional flags may be applied based 
on emerging data. 
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Table 9 
PK Parameter Flags and Footnotes 
Flag 
Footnote 
a 
Adjusted rsq of regression (the goodness of fit statistic for the elimination phase) was <0.8  
b 
Period used for regression analysis was less than 2-fold the calculated half-life 
c 
Extrapolated portion of AUC(0-inf) >20% 
d 
Insufficient post-Cmax data points for estimation of lambda-z 
e 
Entire profile BLQ, no PK parameters could be calculated 
f 
Fewer than 3 consecutive measurable concentrations, AUCs not calculated 
g 
Measurable pre-dose values were observed, however were considered less than 5 % of 
Cmax (Part 2 only) 
 
In the event that the adjusted rsq of regression is <0.8 (“a” flag) then lambda-z and 
parameter estimates derived using lambda-z and AUC(0-inf) will be deemed unreliable 
and will be flagged and listed but excluded from the summary statistics and formal 
statistical analysis. 
In the event that the time period used for regression analysis is less than 2-fold the 
calculated half-life (“b” flag) T1/2 will be flagged, listed, and included in summary 
statistics and formal statistical analysis. 
In the event that the extrapolated portion of AUC(0-inf) >20% (“c” flag), then AUC(0-inf) 
and parameter estimates derived using AUC(0-inf) will be deemed unreliable and will be 
flagged and listed but excluded from the summary statistics and formal statistical 
analysis. 
In the event that there are insufficient post-Cmax data points (i.e., <3) for estimation of 
lambda-z (“d” flag) then lambda-z and parameter estimates derived using lambda-z and 
AUC(0-inf) will be reported as NC. 
In the event that there are fewer than 3 consecutive measurable concentrations (“f” flag) 
then all AUC parameter estimates will be reported as NC. 
In the event that measurable pre-dose values less than 5% of Cmax were observed 
(“g” flag), all parameter estimates for the profiles affected will be listed, flagged and 
included in summary statistics and formal statistical analysis.  
Note: in the event that measurable pre-dose concentrations greater than 5% of Cmax 
are observed, requirements for additional flags and further action will be agreed with 
MMV and documented at the same time as the PK population. 
9.2 
Urine PK Parameter Estimation  
Handling of the urine concentration data is not currently planned analysis in the CSR. 
However, should a validated method be developed and the urine concentrations be 
required to be reported by Quotient in Part 1, then the following should apply to the 
processing of the urine data.  
In Part 1, Cohort 1C and 1D, the urine PK parameters for MMV367 may be derived for 
each participant and collection interval by treatment using SAS. 
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9.2.1 Definition of Urine PK Parameters 
Urine PK parameter definitions are provided in Table 10. 
Table 10 
Urine PK Parameter Definitions and Rounding Specifications 
Parameter 
Definition 
Unit 
DP 
No. of 
DP 
Ae 
Amount excreted 
mass unit 
DP 
2 
CumAe 
Cumulative amount excreted 
mass unit 
DP 
2 
%Ae 
Percentage of dose excreted  
% 
DP 
2 
Cum%Ae 
Cumulative percentage of dose 
excreted  
% 
DP 
2 
DP = decimal places 
Dose is defined as per Table 7 
Urine PK parameters will be calculated as follows: 
• 
When converting urine collection weights to urine volume (if required), the following 
conversion factor will be used: 
1.02 g of urine = 1 mL of urine 
This will be calculated in SAS as follows: 
Urine weight (g) / 1.02 = Urine volume (mL) 
• 
If MMV367 concentrations in urine are provided in mass unit/g the following 
conversion will be performed using SAS: 
Concentration (mass units/g) * 1.02 = Concentration (mass units/mL) 
• 
Ae will be derived for each collection period: 
Ae = concentration * volume 
• 
CumAe, will be calculated by the incremental summation of the Ae over all 
collection periods. Note: The amount excreted in the pre-dose sample should not 
be included in the calculation of the cumulative amount excreted. 
• 
%Ae will be derived for each collection period: 
%Ae = 100 * Ae / Total Dose Administered 
• 
Cum%Ae will be calculated by the incremental summation of the %Ae over all 
collection periods. Note: The percentage of dose excreted in the pre-dose sample 
will not be included in the calculation of the cumulative percentage of dose 
excreted. 
• 
Where a participant has failed to void over a particular collection interval the Ae for 
that collection interval will be set to zero. 
• 
If part of a void over a particular collection interval is missing due to spillage or 
accidental discarding, the Ae will still be calculated providing other samples have 
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been collected within the interval. Where no other samples are collected within the 
interval the concentration will be set to missing for the purposes of the calculation 
urine PK parameters. In both scenarios the data will be flagged to highlight a 
missing void. Affected participant(s) may be excluded from summary statistics, this 
will be documented as part of the PK population.   
• 
Imputation of non-numerical values reported in the urine dataset (i.e., 
concentrations that are BLQ) will be entered as zero for calculation of urine PK 
parameters. 
9.3 
Concentration and PK Parameter Summary Tables 
Summary statistics (i.e., n, mean, SD, CV%, median, minimum, maximum, geometric 
mean, geometric SD and geometric CV%) of concentration data will be calculated for 
each time point and treatment for MMV367 in plasma. The number of BLQ values (n#) 
per time point will also be presented. Geometric statistics will not be calculated for Day 1, 
pre-dose concentrations.  
Summary statistics (i.e., n, mean, SD, CV%, median, minimum and maximum) of plasma 
PK parameters will be calculated for MMV367 for each treatment and day (where 
appropriate). Geometric mean, geometric SD and geometric CV% will be presented for 
all plasma PK parameters except Tmax.  
In Part 1, Cohort 1C and 1D, should a validated method be developed, and the urine 
concentrations be required to be reported by Quotient in Part 1, urine Ae and CumAe 
will be summarised using the n, mean, SD, CV%, median, minimum, and maximum) 
whilst %Ae and Cum%Ae will be summarised using the n, mean, SD, CV%, median, 
minimum and maximum only. 
Non-measurable values reported in the plasma concentration data (i.e., values that are 
BLQ), will be entered as zero for the determination of summary statistics with the 
exception of geometric means, geometric SD and geometric CV%, where BLQ values 
will be imputed as half the lower limit of quantification (LLOQ) value. This also applies to 
any concentrations that are defined as PK parameters. Data recorded as NR, NS or NC 
will be handled as missing (i.e., no assumption will be made about the actual 
concentration). 
9.4 
Concentration and PK Figures 
Mean, spaghetti and individual plasma concentration vs time plots will be produced on 
both the linear/linear scale and on log10/linear scale. For all plots on a linear/linear scale, 
pre-dose concentration values reported as BLQ will be set to zero. Post-dose 
concentration values reported as BLQ will be set to zero, up to the point at which all 
concentrations fall below the LLOQ, after which they will be presented as missing. For 
all plots on a log 10/linear scale, pre-dose concentration values reported as BLQ will be 
presented as missing. Post-dose concentration values reported as BLQ will be set to half 
the BLQ value, up to the point at which all concentrations fall below the LLOQ, after 
which they will be presented as missing.  Where curves from multiple treatment regimens 
or subjects are overlaid on the same plot, symbols will be used to identify different 
subjects/ treatment regimens and a legend will be included on the plots to define the 
symbols used. 
 
 
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Mean plasma concentration vs time plots (using nominal times) will be produced for: 
Part 1 
• 
All treatments on the same plot (1 plot with up to 5 profiles) 
Part 2 
• 
Fed and Fasted treatments on the same plot (1 plot with 2 profiles)  
Part 3 
• 
All treatments on the same plot with separate plots for Day 1 and Day 3 (2 plots 
with up to 3 profiles per plot) 
• 
Day 1 and Day 3 on the same plot, with separate plots for each treatment (up to 3 
plots with 2 profiles per plot) 
These will be produced as follows: 
• 
Linear/linear scale using arithmetic mean concentrations (error bars ± arithmetic 
SD) 
• 
Log10/linear scale using geometric mean concentrations (error bars x/÷ geometric 
SD) 
Separate plasma concentration vs time spaghetti plots (using actual sampling time after 
dosing) will be produced for each treatment (and Day in Part 3) with each plot displaying 
1 line per participant. 
In Part 2, individual plasma concentration vs time plots (using actual sampling times after 
dosing) will be produced separately for each individual participant with fed and fasted 
treatments on the same plot in Part 2. Additionally, in Part 3, individual plasma 
concentration vs time plots will be produced separately for each participant and each 
Day, as well as each individual participant and both Days on the same plot.  
For the food effect comparison in Part 2, scatter plots of individual plasma PK parameter 
values for Cmax, AUC(0-last) and AUC(0-inf). The PK parameter estimates will be 
plotted on the y-axis (linear scale) and regimen on the x-axis. Each participant’s 
individual points will be connected with a line. In addition, the corresponding geometric 
mean parameter values will be plotted using a different symbol and connected with a 
thicker line. Separate plots will be produced for each parameter. 
9.5 
Concentration and PK Listings 
The sample collection data (e.g., collection times) for PK samples will be listed. In 
addition, all concentration data and PK parameters will be listed on a per participant 
basis. Any flags used will be included as a footnote with the appropriate definition. 
9.6 
Statistical Analysis of PK Parameters 
9.6.1 Part 1 and Part 3: Assessment of Dose Proportionality  
Formal statistical analysis will be performed on the PK parameters Cmax, AUC(0-last) 
and AUC(0-inf) in Part 1, and Cmax and AUC(0-tau) in Part 3, including data from up to 
5 different dose levels in Part 1 and up to 3 different dose levels, on Day 1 and Day 3 
separately in Part 3 to assess dose proportionality. This will be assessed using a power 
model as follows: 
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where  and  are the intercept and the slope of the model, respectively. The PK 
parameters will be undergo a natural log transformation. The model will include the log 
dose as a fixed effect and log PK parameter as the dependent variable The analysis will 
be performed using SAS Software procedure PROC MIXED, the method will be specified 
as Restricted Maximum Likelihood and the denominator degrees of freedom for the fixed 
effects will be calculated using Kenward and Roger’s method. 
The model is usually referred to as a power model [1] as after exponentiation: 
 
The estimate obtained for  together with its 90% CI will be presented along with the 
number of subjects and the geometric means.  
The following is an example of the SAS Software code that will be used: 
PROC MIXED DATA=<input dataset name> METHOD=REML ORDER=INTERNAL; 
 
MODEL LVAR= LDOSE / SOLUTION OUTP=PRED DDFM=KR CL ALPHA=0.10; 
 
ODS OUTPUT SOLUTIONF=EST; 
RUN; 
Where LVAR is the log transformed PK parameter and LDOSE is the log transformed 
dose. 
Dose proportionality will be assessed against the critical region defined by the formula 
below [2][3]: 
1 + 
ln (θL) 
< β < 
1 + ln (θH) 
ln (r) 
ln (r) 
 
where:  θL = 0.50  
 
θH = 2.00  
 
r = ratio highest dose level/lowest dose level 
              β = slope of line as a measure of dose proportionality from power model 
If the 90% CI for β lie entirely within the critical region defined above, dose proportionality 
will be concluded over the dose range under analysis. The critical region will be 
calculated using SAS Software as part of the statistical analysis and presented in the 
analysis table as a footnote. 
In addition, the power model will be used to estimate the increase in the PK parameter 
resulting from a doubling in the dose i.e., 2β 90% CI associated with this estimate will 
also be provided. 
This analysis will be performed if there is quantifiable plasma PK data for a minimum of 
3 active dose levels. Dose levels will be included in the analysis if quantifiable plasma 
PK data is available for a minimum of 3 subjects within the relevant dose level. 
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Where dose proportionality cannot be concluded over the full dose range then dose 
proportionality may be assessed over a reduced dose range to identify if dose 
proportionality exists over a narrower dose range. 
9.6.2 Part 2: Assessment of Food Effect 
Formal statistical analysis will be performed on the PK parameters Cmax, AUC(0-last) 
and AUC(0-inf), to assess the presence of a food effect. The null hypothesis is that there 
is no difference between fed and fasted treatments. 
The PK parameters will undergo a natural logarithmic transformation and will be 
analysed using mixed effect modelling techniques. The model will include terms for 
fed/fasted status and period fitted as fixed effects and participant fitted as a random 
effect. 
Only subjects who complete both the fed and fasted periods will be included in the 
statistical analysis. Furthermore, for AUC(0-inf) only, a participant must have reliable 
estimates of AUC(0-inf) for both fed and fasted periods to be included in the statistical 
analysis. If the number of subjects with reliable estimates for both periods is less than 4 
(i.e., less than 50% of planned number of evaluable subjects) then no formal statistical 
analysis of AUC(0-inf) will be performed i.e., descriptive summaries only. 
The adjusted means including differences from the fed/fasted comparison and the 
associated 90% CIs obtained from the model are back transformed on the log scale to 
obtain adjusted geometric mean ratios (GMRs) and 90% CIs of the ratio. These will be 
presented together with the p-value from the fed/fasted comparison.  
The fixed effects table from the model with F-statistic and p-value for the relevant effects 
will be presented in a separate table. 
The intra-participant variability values will be calculated for all treatments combined and 
are obtained from the residual term from the SAS Software output. These values are 
calculated as follows: 
CVw = 100 x (exp(Mean Square Error) -1)1/2 
The analysis will be performed using the SAS Software procedure PROC MIXED, the 
method will specified as Restricted Maximum Likelihood and the denominator degrees 
of freedom for the fixed effects will be calculated using Kenward-Roger method [4]. The 
following is an example of the SAS Software code that will be used: 
PROC MIXED DATA=<input dataset name> METHOD=REML ORDER=INTERNAL; 
 
CLASS SUBJIDN FSTATUS APERIODN; 
 
MODEL LVAR = FSTATUS APERIODN / OUTP=PRED DDFM=KR; 
 
RANDOM SUBJIDN; 
 
ESTIMATE <relevant pairwise treatment comparisons> / CL ALPHA=0.10; 
 
LSMEANS TRTAN / ALPHA=0.10; 
 
LSMEANS=MEANS ESTIMATES=EST COVPARMS=CVW; 
RUN;  
where  
• 
LVAR is the natural log transformed PK parameter of interest 
• 
SUBJIDN is the numeric participant identifier variable 
• 
APERIODN is the numeric period variable 
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• 
FSTATUS is the numeric variable representing fasted or fed status 
For each analysis, distributional assumptions underlying the statistical analyses will be 
assessed by visual inspection of residual plots. Normality will be examined by normal 
probability (QQ) plots, while homogeneity of variance will be assessed by plotting the 
residuals against the predicted values for the model. If the distributional assumptions for 
the parametric approach are not satisfied, then additional sensitivity analyses may be 
performed including the removal of potential outliers or the use of non-parametric 
methods to assess the robustness of the original analysis. This will be documented in 
the CSR together with the reasoning supporting the most appropriate action taken, if 
applicable. In general terms the results of the original analysis will always be presented 
in the CSR. 
9.6.3 Statistical Figures for Analysis of Pharmacokinetic Data 
In Part 1, to complement the dose proportionality assessment the geometric mean values 
of the PK parameters used to evaluate dose proportionality, along with the geometric 
SDs from the mean will be presented graphically on a log10 scale by log10 (dose level).  
Additionally, the individual values for PK parameters used in the evaluation of dose 
proportionality will also be presented graphically on a log10 by log10 (dose level) scale 
and the power model regression line will be included on these plots.  
9.7 
Interim Pharmacokinetic Analysis 
The details of the planned interim PK analysis are described in this section. However, as 
the analysis will be performed in real time it may be necessary to change the planned 
analysis in response to the emerging data. 
Summary tables and figures for the interim PK analysis will be presented in an Interim 
PK Summary Report after being exported from WinNonlin. The formatting of this output 
will differ slightly from the final PK output which will be produced using SAS to include in 
the CSR. 
The interim PK analysis will be performed on QC checked concentration data for 
MMV367 in plasma using nominal sampling times and doses. Measures will be taken to 
maintain the study blind according to Section 5.7. 
The following PK parameters will be calculated for the interim analysis: 
Part 1: 
Tmax, Cmax, AUC(0-24), AUC(0-48), AUC(0-last), AUC(0-inf), T1/2. 
Part 3 Day 1: 
Tmax, Cmax, AUC(0-tau) 
Part 3 Day 3: 
Tmax, Cmax, AUC(0-tau), T1/2, AR Cmax, AR AUC 
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10 Taste Assessment 
For Part 1 only, Taste/Palatability will be assessed using a questionnaire (example 
provided in Appendix 7 at the time points detailed in Appendix 4. The questionnaire will 
ask participants to rate the overall acceptability of taste/palatability, with additional 
questions asked on specific palatability attributes (smell, sweetness, bitterness, flavour, 
mouth feel/texture, grittiness, and aftertaste), on a 9-point Likert scale. The clinical staff 
will provide definitions and examples of each aspect that is being rated if required. 
Each participant in Part 1 of the study will complete the questionnaire individually and 
privately, within no more than 10 min, following IMP administration. 
10.1 Summary Tables for Taste Questionnaire Assessments 
Acceptability of taste (overall liking of product) will be summarised (i.e., n, mean, SD, 
median, minimum and maximum) by treatment. 
For each of the taste attributes described above, the number and percentage of subjects 
who selected each taste rating on the 9-point scale and/or N/A will be summarised by 
treatment. The safety population will be used as the denominator in the calculation of 
percentages. 
10.2 Listings for Taste Questionnaire Assessments 
All taste assessments data will be listed. 
10.3 Statistical Figures for Analysis of Taste Questionnaire Data 
In Part 1, to complement to assessment of the taste questionnaire data, boxplots of each 
dose level will be produced separately for each taste attribute and overall acceptability. 
Dose level will be plotted on the X axis and taste assessment score will be plotted on the 
Y axis (i.e., 1=Dislike extremely, 2=Dislike very much etc.).  
Additionally, bubble plots of each taste attribute and overall acceptability will be 
produced. Each dose level will be plotted on the X axis, with the assessment score 
plotted on the Y axis. Each bubble will contain a count of the number of subjects which 
scored a particular outcome. The size of the bubble will reflect the count (i.e., The bubble 
associated which the most popular score will be the biggest).  
11 Safety Assessments 
Safety data summaries will be presented by actual treatment and the safety analysis set 
will be used throughout. 
11.1 Extent of Exposure and Treatment Compliance 
The number and percentage of subjects dosed with IMP (each day, Part 3 only), will be 
presented for all placebo, all active, and each active dose level separately in Part 1 and 
Part 3, and by treatment received in Part 2. 
Dosing details (including the date and time of all IMP administrations and any comments) 
will be listed for all enrolled subjects. Any recorded deviations from the planned dosing 
regimen will be listed as protocol deviations. Total number of days of exposure and 
measures of compliance will be included in the listing (Part 3 only). 
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11.2 Meal Details 
For Part 2 only, meal details as recorded on the electronic case report form (eCRF) will 
be listed for all enrolled subjects. Any recorded deviations from the planned mealtimes 
will be listed as protocol deviations. 
11.3 Adverse Events 
Throughout the study, all AEs will be evaluated by the PI and noted in the AE section of 
the eCRF. An AE is any untoward medical occurrence in a participant that occurs either 
before dosing (referred to as a pre-dose AE) or once a medicinal product has been 
administered, including occurrences which are not necessarily caused by or related to 
that product. 
AEs will be coded using the Medical Dictionary for Regulatory Activities MedDRA v25.0 
(or more recent version), and reported by SOC and PT. 
AEs will be classified into the following categories: 
• 
Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the 
first dose of IMP  
• 
Treatment-emergent AEs (TEAEs): AEs that commence during/after the first dose 
of IMP or commence before first dose of IMP (i.e., a pre-dose AE or existing 
medical condition) but worsen in intensity during exposure to IMP 
For Part 2 only, TEAEs will be assigned to the treatment of the period in which the AE 
first occurred. Where the severity of an AE intensifies or symptoms change in a 
subsequent period, this will be defined as a new AE and included under the regimen 
associated with the subsequent period. Adverse events that occur during the washout 
period will be assigned to the treatment the participant received during the period 
immediately before the washout period. 
Adverse events will be classified as “mild,” “moderate” or “severe” when considering their 
severity 
Adverse events will be classified as “unrelated”, or “related” when considering their 
relationship to IMP. TEAEs classified as “related”, will be defined as IMP-related events. 
Pre-dose AEs will always have the classification of “unrelated 
If the severity or relationship to IMP of a TEAE is missing, the severity/relationship will 
be tabulated as “missing” in the summary tables 
When summary presentation is made by maximum severity, “missing” will be handled as 
follows: 
• 
If there are other events (i.e., same SOC and PT code) with a maximum severity 
recorded as “moderate” or “severe” for that participant and regimen, then the 
maximum observed severity for that participant will be categorised and presented 
as “moderate” or “severe”, respectively 
• 
If there are other events (i.e., same SOC and PT code) with a maximum severity 
recorded as “mild” for that participant and regimen, then the maximum observed 
severity for that participant will be categorised and presented as “missing” 
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When summaries are presented by relationship to IMP, “missing” will be handled as 
follows: 
• 
If there are other events (i.e., same SOC and PT code) with a most closely related 
association recorded as “related” for that participant and regimen, then the 
maximum observed relationship for that participant will be categorised and 
presented as “related”, respectively 
• 
If there are other events (i.e., same SOP and PT code) with a most closely related 
association recorded as “unrelated” for that participant and regimen, then the 
maximum observed relationship for that participant will be categorised and 
presented as “missing” 
Where the start date of an AE is missing and the stop date is on or after the day of first 
dose of IMP or both the start and stop dates are missing then a “worst-case” scenario 
will be assumed i.e., the AE is assumed to have occurred post-dose and is therefore 
considered treatment-emergent. If a partial start date/time is available then the event will 
be considered as treatment-emergent unless the partial information suggests otherwise. 
11.3.1 Summary Tables for Adverse Events 
All pre-dose AEs (as defined in Section 11.3 will be excluded from the summary tables 
but will be listed for all enrolled subjects.  
Descriptive statistical methods will be used to summarise the TEAE data.  
For each study part, the number and percentage of subjects reporting each TEAE will be 
presented for both SOC and PT. For summaries by SOC and PT, with the exception of 
TEAEs by severity and relationship to IMP, the number of subjects and the number of 
events will be summarised. For summaries by severity and relationship only the number 
of subjects will be summarised. 
For counts of subjects experiencing events the following will apply: 
Part 1 and Part 3: 
• 
A participant with a TEAE in more than one body system will be counted once in 
the total number of subjects with TEAEs 
• 
A participant with more than 1 TEAE in the same SOC counts only once at the SOC 
level 
• 
A participant with more than 1 TEAE in the same PT counts only once at the PT 
level 
Part 2: 
• 
A participant experiencing TEAEs in more than one body system, within a period, 
will be counted once in the total number of subjects with TEAEs in that period  
• 
A participant with more than 1 TEAE in the same SOC, within a period, counts only 
once at the SOC level 
• 
A participant with more than 1 TEAE in the same PT, within a period, counts only 
once at the PT level 
For event counts, all events are included. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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When it is necessary to calculate percentages, the denominator will be the total number 
of subjects in the safety analysis set (and period – Part 2 only), and the numerator will 
be the total number of subjects reporting a TEAE within the relevant category. 
Summaries presented for SOC and PT will be presented in descending order of 
frequency overall i.e., most frequently reported SOC in the study part and then by most 
frequently reported PT in the study part within each SOC. 
11.3.1.1 Overall Summary of Adverse Events 
The following will be summarised by treatment and overall, in Part 2, and by all placebo, 
all active, and each dose level in Part 1 and Part 3 for the safety analysis set: 
• 
Number and percentage of subjects reporting at least 1 TEAE 
• 
Number and percentage of subjects reporting severe TEAEs 
• 
Number and percentage of subjects reporting IMP-related TEAEs 
• 
Number and percentage of subjects reporting serious TEAEs 
• 
Number and percentage of subjects reporting TEAEs leading to participant 
withdrawal 
• 
Number and percentage of subjects reporting TEAEs leading to death 
• 
Total number of TEAEs 
• 
Total number of severe TEAEs 
• 
Total number of IMP-related TEAEs 
• 
Total number of serious TEAEs 
• 
Total number of TEAEs leading to participant withdrawal  
• 
Total number of TEAEs leading to death  
11.3.1.2 Summary of Treatment-Emergent Adverse Events  
All subjects reporting TEAEs will be summarised by treatment and overall in Part 2, and 
by all placebo, all active and each dose level in Part 1 and Part 3. Counts will be given 
for number of subjects and number of events. Subjects experiencing more than 1 TEAE 
treatment will be counted only once for number of subjects but will be counted more than 
once for number of events. 
Additionally, subjects reporting TEAEs will be summarised for SOC and PT by treatment 
and overall in Part 2, and by all placebo, all active and each dose level in Part 1 and 
Part 3. Counts will be given for number of subjects and number of events. Subjects 
experiencing more than 1 episode of a TEAE within a treatment will be counted only 
once within each SOC and PT using the most severe episode. 
11.3.1.3 Summary of Treatment-Emergent Adverse Events by Severity 
All subjects reporting TEAEs will be summarised by severity (i.e., mild, moderate or 
severe) and by treatment in Part 2, and by all placebo, all active and each dose level in 
Part 1 and Part 3. Counts will be given for number of subjects, not number of events. 
Counts will be given by maximum severity (i.e., subjects experiencing more than 1 TEAE 
within a treatment will be counted only once using the most severe episode). 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Additionally, subjects reporting TEAEs will be summarised for SOC and PT by maximum 
severity (i.e., mild, moderate or severe) and by treatment in Part 2, and by all placebo, 
all active and each dose level in Part 1 and Part 3. Counts will be given for total number 
of subjects, not for events. Counts by maximum severity will be given (i.e., subjects 
experiencing more than 1 TEAE within a treatment will be counted only once within each 
SOC and PT using the most severe episode). 
11.3.1.4 Summary of Treatment-Emergent Adverse Events by Relationship to IMP 
All subjects reporting TEAEs will be summarised by relationship to IMP (i.e., unrelated, 
or related) and by treatment in Part 2, and by all placebo, all active and each dose level 
in Part 1 and Part 3. Counts will be given for number of subjects, not number of events. 
Counts will be given by the closest relationship to IMP (i.e., subjects experiencing more 
than 1 TEAE within a treatment will be counted only once using the most closely related 
event). 
Additionally, subjects reporting TEAEs will be summarised for SOC and PT by closest 
relationship to IMP (i.e., unrelated or related) by treatment in Part 2, and by all placebo, 
all active and each dose level in Part 1 and Part 3. Counts will be given for total number 
of subjects, not for events. Counts by closest relationship will be given (i.e., subjects 
experiencing more than 1 TEAE within a treatment will be counted only once within each 
SOC and PT using the most closely related event). 
11.3.1.5 Summary of IMP-related Treatment-Emergent Adverse Events by System 
Organ Class and Preferred Term 
All subjects reporting IMP-related TEAEs will be summarised by treatment in Part 2, and 
by all placebo, all active and each dose level in Part 1 and Part 3. Counts will be given 
for number of subjects and number of events. Subjects experiencing more than 1 IMP-
related TEAE within a treatment will be counted only once for number of subjects but will 
be counted more than once for number of events. 
Additionally, subjects reporting IMP related events will be summarised for SOC and PT 
by treatment in Part 2, and by all placebo, all active and each dose level in Part 1 and 
Part 3. Counts will be given for number of subjects and number of events. Subjects 
experiencing more than 1 episode of an IMP-related TEAE within a treatment will be 
counted only once within each SOC and PT using the most severe episode. 
11.3.1.6 Summary of Serious Adverse Events 
All subjects reporting treatment-emergent serious AEs (SAEs) will be summarised by 
treatment in Part 2, and by all placebo, all active and each dose level in Part 1 and Part 
3. Counts will be given for number of subjects and number of events. Subjects 
experiencing more than 1 SAE within a treatment will be counted only once for number 
of subjects but will be counted more than once for number of events. 
Additionally, subjects reporting treatment-emergent SAEs will be summarised for SOC 
and PT by treatment in Part 2, and by all placebo, all active and each dose level in Part 1 
and Part 3. Counts will be given for number of subjects and number of events. Subjects 
experiencing more than 1 episode of a SAE within a will be counted only once within 
each SOC and PT using the most severe episode. 
11.3.2 Listings for Adverse Events 
All pre-dose AEs (as defined in Section 11.3) will be listed including SOC and PT. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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A separate data listing of all TEAEs will be provided including the SOC and PT. In 
addition, a listing of all SAEs will be provided. 
11.4 Laboratory Evaluations 
The details of sample collection for laboratory safety analysis are described in the study 
protocol. 
Where a value is provided by the safety laboratory as either above or below the limit of 
detection (LOD) this will be set to the respective LOD itself for descriptive summaries. 
No imputations will be made in the individual listings. 
11.4.1 Summary Tables for Laboratory Evaluations 
For each study part, haematology, coagulation and clinical chemistry data will be 
summarised (n, mean, SD, median, minimum and maximum) for each laboratory 
parameter at each time point, including changes from baseline (Admission, Day-1) at 
each scheduled post-baseline time point by treatment in Part 2, and by all placebo, all 
active and each dose level in Part 1 and Part 3.  
Shift tables from baseline to each scheduled post-baseline time point (with respect to the 
number and percentage of subjects with values below, within or above the reference 
range) will be presented by treatment in Part 2, and by all placebo, all active and each 
dose level in Part 1 and Part 3. Percentages will be based on the number of subjects 
with measurements at baseline and the relevant post-baseline time point. 
For fasting-sensitive laboratory parameters (i.e., glucose) results taken in the non-fasted 
state (i.e., LBFAST=N) will not be included in summary statistics by time point or be used 
in derivations of changes from baseline. For tabulations (e.g., shift tables) both fasted 
and non-fasted results will be pooled and used in the tabulations, using the appropriate 
fasted or non-fasted reference range. All results (fasted or non-fasted) will be listed with 
non-fasted data flagged. 
Reference ranges for each laboratory parameter will be presented for the relevant 
parameter in each summary table. 
11.4.2 Listings for Laboratory Evaluations 
For each study part, the sample collection data (e.g., collection times) for laboratory 
analysis and urinalysis data will be listed. 
All individual participant data, for planned haematology, clinical chemistry and urinalysis 
data including derivations, such as change from baseline, will be listed. If applicable, 
data from unscheduled laboratory tests will also be listed and flagged with a “#” to 
indicate it will not be used in the summary statistics. In these listings, individual data will 
be flagged with an “H” or an “L” for values that are higher or lower than their reference 
ranges, respectively. 
Separate listings of all haematology, coagulation, clinical chemistry and urinalysis values 
outside their reference ranges by participant will also be provided. Reference ranges will 
be supplied by the safety laboratory for haematology and clinical chemistry and per the 
eCRF for urinalysis (i.e., a positive or negative result) with the exception of the following 
reference ranges for urinalysis: 
• 
pH: 5.0 to 9.0 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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• 
Specific gravity: 1.000 to 1.030 
11.5 Vital Signs  
For each study part, the details of measurement of supine vital signs (i.e., systolic and 
diastolic BP, and heart rate) and non-supine vital signs (oral temperature and respiratory 
rate) will be measured at each scheduled timepoint.  
Systolic and diastolic BP and heart rate orthostatic measurements will also be taken 
(1 supine and 1 standing) according to the time schedules presented in Appendix 4 
(Part 1), Appendix 5 (Part 2) and Appendix 6 (Part 3). Vital signs parameters will be 
reported in the order given above, i.e., both summary tables and data listings. 
11.5.1 Summary Tables for Vital Signs 
For each study part, vital signs data (including orthostatic measurements), and change 
from baseline (Pre-dose, Day 1 (Period 1), Day 8 (Period 2), will be summarised (i.e., n, 
mean, SD, median, minimum and maximum) at each post-baseline time point by 
treatment in Part 2, and by all placebo, all active and each dose level in Part 1 and Part 3.  
In addition, the number of subjects with ‘substantial’ increases or decreases or no 
substantial change from baseline in systolic BP (>20 mmHg), diastolic BP (>10 mmHg) 
and heart rate (>15 bpm) will be summarised. 
Orthostatic hypotension will also be investigated at each time point. The change in 
systolic BP and diastolic BP between the mean of the duplicate supine measurements 
and the subsequent standing measurement will be calculated for each subject (i.e., 
standing BP- Supine BP) and summarised (i.e., mean, SD, median, minimum, maximum 
and n) at baseline and each post-baseline time point.   
In addition, the number of subjects with ‘substantial’ decreases or no substantial 
decrease from supine to standing results in systolic BP (>20 mmHg) and diastolic BP 
(>10 mmHg) will be presented at each time point. 
11.5.2 Listings for Vital Signs 
For each study part, all individual vital signs data (including orthostatic measurements) 
and derivations, such as change from baseline, will be listed. Individual data will be 
flagged with an “H” or an “L” for values that are higher or lower than their reference 
ranges, respectively, and subjects with ‘substantial’ increases or decreases from 
baseline (as defined in Section 11.5.1) in systolic BP, diastolic BP and heart rate will be 
flagged with an ‘I’ (increase) or ‘D’ (decrease), respectively. If applicable, data from 
unscheduled vital signs assessments will also be listed and flagged with a “#” to indicate 
it will not be used in the summary statistics. 
In addition, a separate listing of all vital signs data outside their reference ranges by 
participant will also be provided. 
The reference ranges (from Quotient SOP “The Interpretation of the Electrocardiogram, 
Vital Signs and Clinical Laboratory Data During Phase I / II Clinical Trials”) defined in 
Table 11 will be used. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 11 
Vital Signs Reference Ranges 
Parameter 
Lower limit 
Upper limit 
Systolic BP 
90 mmHg 
140 mmHg 
Diastolic BP 
50 mmHg 
90 mmHg 
Heart rate 
45 bpm 
100 bpm 
Oral Body Temperature 
35.5ºC 
37.5ºC 
Respiration Rate 
10 breaths/min 
24 breaths/min 
NA=Not applicable 
11.6 ECGs 
For each study part, the details of measurement of supine ECG parameters (i.e., 
ventricular rate, RR interval, QT interval, QTcF interval, PR Interval, QRS duration, QRS 
axis, rhythm, interpretation and clinical significance and findings) are described in the 
study protocol. ECG parameters will be reported in the order given above, i.e., both 
summary tables and data listings.   
Triplicate 12-lead ECGs (2 min apart) will be obtained after the participant has been in 
the supine position for a minimum of 5 min. 
On Day 1 of Parts 1 and 2, telemetry (continuous ECG monitoring) will commence at 
least 30 min before dosing until at least 12 h post-dose. As this monitoring is for safety 
purposes alone no data will be recorded in the source, except the start and stop time. If 
cardiac monitoring shows a potentially significant abnormality, a clinical assessment of 
the participant including a 12 lead ECG will be performed and treatment given, if 
appropriate. 
11.6.1 Summary Tables for ECGs 
For each study part and time point where triplicate ECGs are taken the arithmetic mean 
of the triplicate values for each 12-lead ECG measurement will be computed for each 
participant. These arithmetic means will then be used to compute the summary statistics 
for the observed values and for the change from baseline values. If 1 of the 
3 measurements is missing, the mean of the 2 non-missing measurements will be used. 
If 2 measurements are missing, the remaining non-missing value will be used. 
ECG data, including change from baseline (mean of single 12-lead measurement, Pre-
dose, Day 1 of each dosing period where applicable), will be summarised (i.e., n, mean, 
SD, median, minimum and maximum) at each post-baseline time point by treatment in 
Part 2 and by all placebo, all active and each active dose in Part 1 and Part 3. 
For each study part, the number and percentage of subjects with normal and prolonged 
QT intervals corrected for heart rate using Bazett’s correction (i.e., QTcB) and Fridericia’s 
correction (i.e., QTcF) and increases in QTcB and QTcF intervals from baseline within 
the categories defined in Table 12 (based on the International Council on Harmonisation 
[ICH] E14 guideline [5]) will be summarised by time point and overall. Percentages will 
be based on the number of subjects with measurements at the relevant time point. 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 12 
ICH E14 Ranges for QTcB and QTcF Intervals 
Parameter 
ICH E14 Range 
QTcF/ QTcB interval 
≤450 msec (normal) 
>450msec 
>480 msec 
>500 msec 
Increase in QTcF/ QTcB interval 
from baseline 
≤30 msec 
>30 msec 
>60 msec 
11.6.2 Listings for ECGs 
For each study part, all ECG measurements (i.e., single and mean of triplicate readings) 
including derivations, such as change from baseline, will be listed. 
All ECG measurements will be flagged with an “H” or an “L” for values that are higher or 
lower than their reference ranges, respectively. If applicable, data from unscheduled 
ECG assessments will also be listed and flagged with a “#” to indicate it will not be used 
in the summary statistics. 
In addition, for the single values obtained from Single 12-lead measurement, and the 
mean values calculated from the triplicate ECG values, the number of subjects with 
increase in QTcF interval from baseline (>30 msec) and with ‘substantial increases’ (>60 
msec) will be flagged with ‘I’ and ‘SI’, respectively. 
A separate listing of all ECG parameters outside their reference range by participant will 
also be provided. The reference ranges (from Quotient SOP “The Interpretation of the 
Electrocardiogram, Vital Signs and Clinical Laboratory Data During Phase I / II Clinical 
Trials”, except QT interval which is from the eCRF) defined in Table 13 will be used. 
Additionally, for Part 1 and Part 2 only, the telemetry start and stop times, as well as the 
nature of any potentially significant abnormality will be listed.   
Table 13 
ECG Reference Ranges 
Parameter 
Lower limit 
Upper limit 
Ventricular Rate (HR) 
45 bpm 
100 bpm 
QT Interval 
200 msec 
600 msec 
QTcB/QTcF Interval 
NA 
450 msec 
PR Interval 
120 msec 
210 msec 
QRS Duration 
NA 
120 msec 
QRS Axis 
-30º 
100º 
HR=heart rate 
NA=Not applicable 
11.7 Body Weight 
In Part 1 and Part 3, all body weight data will be listed. 
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11.8 Physical Examination  
All physical examination and targeted physical examination details and comments on 
any findings will be listed by participant for all subjects. 
12 Interim Statistical Analyses 
No interim statistical analysis is planned for this study. 
13 Changes in the Conduct of the Study or Planned Analysis 
13.1 Changes in the Conduct of the Study 
No changes in the conduct of the study had been reported at the time this document was 
written. 
13.2 Changes to the Planned Analyses 
No changes to planned analysis. 
13.3 Any Other Relevant Changes 
Not applicable. 
14 Overall Considerations 
14.1 Statistical Programming and Analysis 
The Data Sciences Department at Quotient will perform the statistical programming and 
analysis to produce all analysis datasets and TFLs using the statistical SAS Software 
v9.4. 
In general terms, categorical data will be presented using counts and percentages, while 
continuous variables will be presented using n, mean, SD, median, minimum and 
maximum. For PK data additional statistics including CV%, geometric mean, geometric 
SD and geometric CV% will be presented, as appropriate. 
The geometric mean is obtained by applying a natural log transformation to the raw data, 
calculating the arithmetic mean of the transformed values and then back transforming 
the arithmetic mean. 
The following formula will be used to calculate the geometric SD: 
geometric SD = exp{SD[log(raw data)]} 
ie, a natural log transformation is applied to the raw data, the arithmetic SD of the 
transformed values is calculated, and then the arithmetic SD of the transformed values 
is back transformed. 
The following formula will be used to calculate the geometric CV%: 
geometric CV% = 100 × (exp{SD[(log(raw data)]}2 -1)1/2 
ie, a natural log transformation is applied to the raw data, the arithmetic SD of the 
transformed values is calculated. This value is then squared. The square value is back 
transformed and a value of 1 is subtracted from the back transformed value. A square 
root is then applied and the resulting value is multiplied by 100. 
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In general summary statistics and statistical analysis results will be presented as detailed 
in Table 14, unless otherwise stated: 
Table 14 Reporting Conventions for Summary Statistics and Statistical Analysis 
 
Data Type 
Statistic 
Number of decimal places for reporting (i) 
Frequency 
Counts (n) 
None 
Percentages (%) 
1 decimal place 
Summary statistic 
n 
None 
Mean 
i + 1 decimal places 
Median 
i + 1 decimal places 
SD 
i + 1 decimal places 
Min 
i decimal places 
Max 
i decimal places 
CV% 
1 decimal place 
Geometric n 
None 
Geometric Mean 
i + 1 decimal places 
Geometric SD 
i + 1 decimal places 
Geometric CV% 
1 decimal place 
Statistical analysis 
Ratios (%) 
2 decimal places 
Confidence intervals (%) 
2 decimal places 
p-values 
if <0.001: presented as <0.001 
if ≥0.001 and <0.099: presented to 3 decimal places 
all other p-values will be presented to 2 decimal places 
i refers to the number of decimal places reported in the eCRF or other appropriate source data for the original 
data. Where bioanalytical or PK data are received rounded in significant figures rather than decimal places, 
summary statistics will be supplied to the same precision. 
Details of how the individual PK parameters will be presented are detailed in 
Section 9.1.1. Where data requires rounding, values ending with 1 to 4 will be rounded 
down and values ending with 5 to 9 will be rounded up. 
All data listings will be based on all enrolled subjects (as defined in Section 3.2.3). Details 
of age and sex will be included on all data listings. 
For the assessment of food effect in Part 2, statistical tests relating to PK parameters will 
be 2-sided and will be performed using a 10% significance level, leading to 90% (2-sided) 
confidence intervals (CIs). 
If any baseline measurements are found to be missing then consideration will be given 
to imputation using the preceding time point (e.g., screening, admission, if applicable). 
Unscheduled assessment may be used if appropriate. Details of any such imputations 
will be documented as part of the safety analysis set. 
There will be no other imputations for the safety data with regard to missing values or 
study discontinuation (i.e., subjects who do not complete the study). Imputation for PK 
parameter estimation using WinNonlin is described in Section 9.1.2. Imputations for 
reporting PK data are described in Section 9.1.3. 
If partial dates are available for smoking history, prior medications or medical/surgical 
history, there will be no date imputations. The data listings will only show the date 
information for the date part that is available, e.g., if only the year part of the date is 
available then YYYY will be presented in the listing. If the full date information is missing, 
then this will be presented as missing on the data listing. 
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Separate summary TFLs will be produced for Part 1, Part 2 and Part 3 of this study, 
respectively. The different parts will be identified by a sub-title indicating the relevant 
part. The text in the remainder of this document refers to both parts, unless specified 
otherwise. All summary tables within a study part  relating to Part 1 or 3, except for the 
plasma PK concentration and plasma and urine PK parameter summary tables will be 
presented by all placebo subjects combined (i.e., all placebo subjects pooled over all 
dose levels), all active doses combined (i.e., all active subjects pooled over all dose 
levels) and all active dose levels separately. Summary tables relating to Part 2 will be 
presented by treatment. For the plasma PK concentration and plasma and urine PK 
parameter summary tables, these will be presented by all treatments separately. Placebo 
subjects will not be included on the PK concentration and plasma and urine PK 
parameter summary tables. TFLs of the same type will have the same TFL numbering 
with the inclusion of a .1 for Part 1 of the study and a .2 for Part 2 of the study etc. If all 
or part of this study is conducted during the Coronavirus disease 2019 [COVID-19] 
pandemic and there is evidence that data relating to primary and/or key secondary 
endpoints may have been affected in a way that may bias results, then sensitivity 
analyses may be conducted. Requirements for any sensitivity analyses will be 
documented at the same time as the related population (i.e., safety /PK population) and 
details of any sensitivity analyses which were carried out would be fully documented in 
the CSR. 
14.2 Quality Control of Summary Tables, Figures and Listings and Statistical 
Analysis 
Isolated data errors detected as a result of the QC checks that are deemed significant 
(i.e., errors that would impact the interpretation of the results in relation to the study 
objectives) will be corrected as per the data management plan. Systematic data errors 
will be investigated further. The data will be corrected if necessary, and the appropriate 
table, figure, and/or listing re-generated and then re-checked. 
In addition to QC checks, a documented peer review will be performed of all SAS 
Software -generated report standard TFLs, including a review of SAS Software code and 
program log files. 
14.2.1 Quality Control - Summary Tables 
Manual QC methods (i.e., comparison of results in the table to results calculated by a 
calculator or spreadsheet) will be used for all analyses and summary tables. All summary 
tables will be QC’d as follows: 
• 
Where tables are presented by sequence or treatment (Part 2), or dose group (Part 
1 and Part 3) (i.e., no time points), QC will alternate between sequence or 
treatment (Part 2) or dose group (Part 1 and Part 3) to avoid the same sequence or 
treatment (Part 2) or dose group (Part 1 and Part 3) being QC’d every timeFor 
tables presented by sequence or treatment (Part 2) or dose group (Part 1 and Part 
3) only (i.e., no time points), all summary statistics for 1 sequence or treatment 
(Part 2) or dose group (Part 1 and Part 3) will be QC’d 
• 
Where tables are presented by treatment, or dose group (Part 1 and Part 3 only) 
and time point, QC will alternate between treatment, or dose group (Part 1 and Part 
3 only) to avoid the same treatment, or dose group (Part 1 and Part 3 only) being 
QC’d every time 
• 
For tables presented by treatment, or dose group (Part 1 and Part 3 only) and time 
point, a single treatment, or dose group (Part 1 and Part 3 only) at 1 time point in 
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each table will be QC’d 
• 
Where tables are produced using a macro for multiple parameters, a minimum of 
3 tables, using different treatment, or dose group (Part 1 and Part 3 only) or 
combinations of treatment, or dose group (Part 1 and Part 3 only) and time point as 
appropriate, will be QC’d 
• 
For AEs, the treatment details will be 100% QC’d against the randomisation 
schedule for all subjects 
• 
AE summary tables will be 100% checked using the relevant data listing 
14.2.2 Quality Control - Figures 
All figures will be QC’d manually using the corresponding/appropriate summary table or 
data listing, as follows: 
• 
Across all figures, QC will alternate between treatment to avoid the same dose 
treatment being QC’d every time 
• 
Where a figure presents data from more than 1  treatment, only 1 treatment will be 
QC’d. However, all data points for that treatment will be checked 
• 
Where figures are produced using a macro for individual subjects and/or multiple 
parameters, a minimum of 3 figures will be QC’d 
• 
Mean figures will be QC’d using the corresponding summary table 
• 
Figures showing individual data will be QC’d using the corresponding data listing 
14.2.3 Quality Control - Data Listings 
In Part 2, all data listings will be subjected to a 100% manual QC check against the eCRF 
or other appropriate source data for a minimum of 2 subjects. If appropriate, the subjects 
checked will include at least 1 participant who withdrew early from the study. 
In Part 1 and Part 3, all data listings will be subjected to a 100% manual check against 
the eCRF or other appropriate source data for a minimum of 2 subjects. If appropriate, 
the subjects checked will include at least 1 participant who withdrew early from the study. 
The study treatment allocation details on the dosing data listing will be 100% QC checked 
against the study randomisation schedule. 
14.2.4 Quality Control - Statistical Analysis 
QC of statistical analyses will be performed by peer review of program code, log and 
output. This will be performed by a statistician at Quotient who is not responsible for 
performing the statistical analysis. 
15 SAS Data Transfer 
The SDTM and ADaM datasets will be transferred to MMV at the following times: 
• 
Prior to database lock (SDTM transfer of safety/eCRF data only) 
• 
On the finalisation of the CSR, with the define.xml 
The SDTM and ADaM datasets will be programmed according to a pre-defined set of 
specifications following Quotient SOP DOC-028861, with reference to SDTM IG 3.2 and 
ADaM IG 1.1. Quotient will provide metadata files and data will be transferred as SAS 
Software transport files. No define .xml output will be included. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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16 Programming Conventions 
Quotient standards for layout of TFLs and programming conventions will be used as 
follows: 
• 
Courier new, font size 8 
• 
Landscape 
• 
A4 paper 
Tables and listings will be produced as MS Word 2016 (or more recent version) 
documents and figures will be produced as PDF files. Listings will be sorted by participant 
ID number and sequence or treatment (Part 2 only) or dose group (Part 1 and Part 3) 
i.e., all subjects in sequence 1 will be presented first, followed by subjects in sequence 2, 
etc. 
The mock tables (Section 21) and titles of all TFLs and the formatting, labelling, footnotes 
and cosmetic appearance of tables may be modified, or additional labelling/footnotes 
may need to be added during analysis and reporting, for clarification purposes. Any such 
changes will not be regarded as changes to planned analyses. 
17 Reference List 
[1] 
Gough K, Hutchison M, Keene O, et al. Assessment of dose proportionality: 
report from the statisticians in the pharmaceutical industry/pharmacokinetics UK 
joint working party. Drug Info J. 1995; 29(3): 1039–1048 
[2] 
Smith BP, Vandenhende FR, DeSante KA, et al. Confidence interval criteria for 
assessment of dose proportionality. Pharmaceutical Research. 2000; 17(10): 
1278–1283. 
[3] 
Hummel J, McKendrick S, Brindley C, et al. Exploratory assessment of dose 
proportionality: review of current approaches and proposal for a practical 
criterion. Pharmaceutical Statist. 2009; 8: 38–49 
[4] 
Brown, Prescott. Repeated measures data. In: Brown H and Prescott R, 3rd 
edition. Applied Mixed Models in Medicine. Chichester, UK: John Wiley & Sons 
Ltd; 2015: 242–243. 
[5] 
International Council for Harmonisation (ICH) Topic E 14, The Clinical Evaluation 
of 
QT/QTc 
Interval 
Prolongation 
and 
Proarrhythmic 
Potential 
for 
Non-Antiarrhythmic Drugs Guidelines approved by the Committee for Medicinal 
Products for Human Use (CHMP) in May 2005 which came into force November 
[6] 
Beck A, Ward C, Mendelson M, et al. An inventory for measuring depression. 
Archives of General Psychiatry. 1961; 4: 561-571 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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18 Index of Tables 
Table 
Number 
Table Title 
 
Participant Disposition, Populations and Datasets 
14.1.1.1 
Participant Disposition by Reason 
Summary Statistics: All Enrolled Subjects 
Part 1 
14.1.2.1.2 
Analysis Populations 
Summary Statistics: All Enrolled Subjects 
Part 1 
14.1.2.1.3 
Safety Analysis Sets 
Summary Statistics: Safety Population 
Part 1 
14.1.2.1.4 
Taste Analysis Set 
Summary Statistics: All Enrolled Subjects 
Part 1 
14.1.2.1.5 
PK Analysis Sets 
Summary Statistics: All Enrolled Subjects 
Part 1 
14.1.1.2 
Participant Disposition by Reason 
Summary Statistics: All Enrolled Subjects 
Part 2 
14.1.2.2.2 
Analysis Populations 
Summary Statistics: All Enrolled Subjects 
Part 2 
14.1.2.2.3 
Safety Analysis Sets 
Summary Statistics: Safety Population 
Part 2 
14.1.2.2.4 
PK Analysis Sets 
Summary Statistics: All Enrolled Subjects 
Part 2 
14.1.1.3 
Participant Disposition by Reason 
Summary Statistics: All Enrolled Subjects 
Part 3 
14.1.2.3.2 
Analysis Populations 
Summary Statistics: All Enrolled Subjects 
Part 3 
14.1.2.3.3 
Safety Analysis Sets 
Summary Statistics: All Enrolled Subjects 
Part 3 
14.1.2.3.4 
PK Analysis Sets 
Summary Statistics: All Enrolled Subjects 
Part 3 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
 
Demographic and Baseline Characteristics 
14.1.3.1 
Demographic and Baseline Characteristics 
Summary Statistics: Safety Analysis Set 
Part 1 
14.1.4.1 
Lifestyle Details: Smoking History and Alcohol Consumption  
Summary Statistics: Safety Analysis Set 
Part 1 
14.1.3.2 
Demographic and Baseline Characteristics 
Summary Statistics: Safety Analysis Set 
Part 2 
14.1.4.2 
Lifestyle Details: Smoking History and Alcohol Consumption  
Summary Statistics: Safety Analysis Set 
Part 2 
14.1.3.3 
Demographic and Baseline Characteristics 
Summary Statistics: Safety Analysis Set 
Part 3 
14.1.4.3 
Lifestyle Details: Smoking History and Alcohol Consumption  
Summary Statistics: Safety Analysis Set 
Part 3 
 
Dosing Details 
14.1.5.1 
Extent of Exposure 
Summary Statistics: Safety Analysis Set 
Part 1 
14.1.5.2 
Extent of Exposure 
Summary Statistics: Safety Analysis Set 
Part 2 
14.1.5.3.1 
Extent of Exposure: Subjects Dosed by Day 
Summary Statistics: Safety Analysis Set 
Part 3 
14.1.5.3.2 
Extent of Exposure: Total Days of Exposure 
Summary Statistics: Safety Analysis Set 
Part 3 
14.1.5.3.3 
Extent of Exposure: Percentage Treatment Compliance 
Summary Statistics: Safety Analysis Set 
Part 3 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
 
Urine Pharmacokinetic Concentrations 
14.2.1.1.1 
Excretion: MMV367 
Ae(Urine) by Collection Period (<units>) 
Summary Statistics: PK Analysis Set 
Part 1 
14.2.1.1.2 
Excretion: MMV367 
Cumulative Ae(Urine) (<units>) 
Summary Statistics: PK Analysis Set 
Part 1 
14.2.1.1.3 
Recovery: MMV367 
%Ae(Urine) by Collection Period 
Summary Statistics: PK Analysis Set 
Part 1 
14.2.1.1.4 
Recovery: MMV367 
Cumulative %Ae(Urine) 
Summary Statistics: PK Analysis Set 
Part 1 
 
Plasma Pharmacokinetic Concentrations 
14.2.1.1.5 
Plasma Pharmacokinetic Concentrations: MMV367<(units)> 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 1 
14.2.1.2.1 
Plasma Pharmacokinetic Concentrations: MMV367<(units)> 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 2 
14.2.1.2.3 
Plasma Pharmacokinetic Concentrations: MMV367<(units)> 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 3 
 
Plasma Pharmacokinetic Parameters 
14.2.2.1.1 
Plasma Pharmacokinetic Parameters: MMV367 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 1 
14.2.2.1.2 
Plasma Pharmacokinetic Parameters: MMV367 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 2 
14.2.2.1.3 
Plasma Pharmacokinetic Parameters: MMV367 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 3 
14.2.2.2.1 
Plasma Pharmacokinetic Parameters: MMV367 
Statistical Analysis Results – Assessment of Dose Proportionality: <PK 
Analysis Set/PK Analysis Subset> 
Part 1 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
14.2.2.2.2 
Plasma Pharmacokinetic Parameters: MMV367 
Statistical Analysis Results – Assessment of Food Effect: <PK Analysis 
Set/PK Analysis Subset> 
Part 2 
14.2.2.2.3 
Plasma Pharmacokinetic Parameters: MMV367 
Statistical Analysis Results – Assessment of Dose Proportionality: <PK 
Analysis Set/PK Analysis Subset> 
Part 3 
 
Adverse Events 
14.3.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.1.2 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.1.3 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Severity 
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.1.4 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Relationship to IMP 
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.1.5 
Treatment-Emergent Adverse Events Related to IMP 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.1.6 
Serious Adverse Events 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 1 
14.3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
Summary Statistics: Safety Analysis Set 
Part 2 
14.3.2.2 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 2 
14.3.2.3 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Severity 
Summary Statistics: Safety Analysis Set 
Part 2 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
14.3.2.4 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Relationship to IMP 
Summary Statistics: Safety Analysis Set 
Part 2 
14.3.2.5 
Treatment-Emergent Adverse Events Related to IMP 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 2 
14.3.2.6 
Serious Adverse Events 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 2 
14.3.3.1 
Overall Summary of Treatment-Emergent Adverse Events 
Summary Statistics: Safety Analysis Set 
Part 3 
14.3.3.2 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 3 
14.3.3.3 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Severity 
Summary Statistics: Safety Analysis Set 
Part 3 
14.3.3.4 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Relationship to IMP 
Summary Statistics: Safety Analysis Set 
Part 3 
14.3.3.5 
Treatment-Emergent Adverse Events Related to IMP 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 3 
14.3.3.6 
Serious Adverse Events 
By MedDRA System Organ Class and Preferred Term  
Summary Statistics: Safety Analysis Set 
Part 3 
 
Laboratory Results 
14.4.1.1 
Haematology and Coagulation  
Summary Statistics: Safety Analysis Set 
Part 1 
Parameter <units> 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
14.4.1.2 
Haematology and Coagulation 
Shift Analysis: Safety Analysis Set 
Part 1 
Parameter <units> 
14.4.1.3 
Clinical Chemistry 
Summary Statistics: Safety Analysis Set 
Part 1 
Parameter <units> 
14.4.1.4 
Clinical Chemistry 
Shift Analysis: Safety Analysis Set 
Part 1 
Parameter <units> 
14.4.2.1 
Haematology and Coagulation 
Summary Statistics: Safety Analysis Set 
Part 2 
Parameter <units> 
14.4.2.2 
Haematology and Coagulation 
Shift Analysis: Safety Analysis Set 
Part 2 
Parameter <units> 
14.4.2.3 
Clinical Chemistry 
Summary Statistics: Safety Analysis Set 
Part 2 
Parameter <units> 
14.4.2.4 
Clinical Chemistry 
Shift Analysis: Safety Analysis Set 
Part 2 
Parameter <units> 
14.4.3.1 
Haematology and Coagulation  
Summary Statistics: Safety Analysis Set 
Parameter <units> 
Part 3 
14.4.3.2 
Haematology and Coagulation 
Shift Analysis: Safety Analysis Set 
Part 3 
Parameter <units> 
14.4.3.3 
Clinical Chemistry 
Summary Statistics: Safety Analysis Set 
Part 3 
Parameter <units> 
14.4.3.4 
Clinical Chemistry 
Shift Analysis: Safety Analysis Set 
Part 3 
Parameter <units> 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
 
Vital Signs and ECG Results 
14.5.1.1 
Vital Signs 
Summary Statistics: Safety Analysis Set 
Part 1 
Parameter <units> 
14.5.2.1.1 
ECGs  
Summary Statistics: Safety Analysis Set 
Single 12-Lead 
Part 1 
Parameter <units> 
14.5.2.1.2 
ECGs  
Summary Statistics: Safety Analysis Set 
Mean of Triplicate 12-Lead 
Part 1 
Parameter <units> 
14.5.2.1.3 
ECGs 
QTcB and QTcF Categorical Data 
Summary Statistics: Safety Analysis Set 
Part 1 
14.5.1.2 
Vital Signs 
Summary Statistics: Safety Analysis Set 
Parameter <units> 
Part 2 
14.5.2.2.1 
ECGs  
Summary Statistics: Safety Analysis Set 
Parameter <units> 
Single 12-Lead 
Part 2 
14.5.2.2.2 
ECGs  
Summary Statistics: Safety Analysis Set 
Mean of Triplicate 12-Lead 
Parameter <units> 
Part 2 
14.5.2.2.3 
ECGs 
QTcB and QTcF Categorical Data 
Summary Statistics: Safety Analysis Set 
Part 2 
14.5.1.3 
Vital Signs 
Summary Statistics: Safety Analysis Set 
Part 3 
Parameter <units> 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Table 
Number 
Table Title 
14.5.2.3.1 
ECGs  
Summary Statistics: Safety Analysis Set 
Parameter <units> 
Single 12-Lead 
Part 3 
14.5.2.3.2 
ECGs  
Summary Statistics: Safety Analysis Set 
Parameter <units> 
Mean of Triplicate 12-Lead 
Part 3 
14.5.2.3.3 
ECGs 
QTcB and QTcF Categorical Data 
Summary Statistics: Safety Analysis Set 
Part 3 
 
Other 
14.6.1.1 
Taste Assessment: Taste Aspects 
Summary Statistics: Taste Analysis Set 
Taste Test Aspect: <xxx> 
Part 1 
14.6.1.2 
Taste Assessment: Overall Acceptability 
Summary Statistics: Taste Analysis Set 
Part 1 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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19 Index of Figures 
Figure 
Number 
Figure Title 
 
Plasma Pharmacokinetic Concentrations: MMV367 
14.2.3.1.1 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Arithmetic Mean (± Arithmetic SD) Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 1 
Programming note: All treatments on the same plot (up to 5 profiles) 
14.2.3.1.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Geometric Mean (×/÷Geometric SD) Values: <PK Analysis Set/PK 
Analysis Subset> 
Part 1 
Programming note: All treatments on the same plot (up to 5 profiles) 
14.2.3.1.3 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 1 
14.2.3.1.4 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 1 
14.2.3.2.1 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Arithmetic Mean (± Arithmetic SD) Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 2 
Programming note: Fed and Fasted treatments on the same plot (2 
profiles) 
14.2.3.2.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Geometric Mean (×/÷Geometric SD) Values: <PK Analysis Set/PK 
Analysis Subset> 
Part 2 
Programming note: Fed and Fasted treatments on the same plot (2 
profiles) 
14.2.3.2.3 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 2 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Figure 
Number 
Figure Title 
14.2.3.2.4 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 2 
14.2.3.2.5 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Part 2 
Programming note: Fed and Fasted treatments on the same plot (2 
profiles 
14.2.3.2.6 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Part 2 
Fed and Fasted treatments on the same plot (2 profiles) 
14.2.3.2.7 
Plasma Pharmacokinetic Values <Cmax>: MMV367 <units> 
Linear/Linear Scale 
Scatter Plot: <PK Analysis Set/PK Analysis Subset> 
Part 2 
14.2.3.3.1 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Arithmetic Mean (± Arithmetic SD) Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 3 
Programming note: All treatments on the same plot – separate plots for 
Day 1 and Day 3 
14.2.3.3.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Geometric Mean (×/÷Geometric SD) Values: <PK Analysis Set/PK 
Analysis Subset> 
Part 3 
Programming note: All treatments on the same plot – separate plots for 
Day 1 and Day 3 
14.2.3.3.3 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Arithmetic Mean (± Arithmetic SD) Values: <PK Analysis Set/PK Analysis 
Subset> 
Part 3 
Programming note: Day 1 and Day 3 on the same plot– separate plots 
for treatments 
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Figure 
Number 
Figure Title 
14.2.3.3.4 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Geometric Mean (×/÷Geometric SD) Values: <PK Analysis Set/PK 
Analysis Subset> 
Part 3 
Programming note: Day 1 and Day 3 on the same plot– separate plots 
for treatments 
14.2.3.3.5 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
<Day> 
Part 3 
14.2.3.3.6 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Spaghetti Plots of All Individual Values: <PK Analysis Set/PK Analysis 
Subset> 
<Day> 
Part 3 
14.2.3.3.7 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Day 1  
Part 3 
Programming note: Separate plots for Day 1 and Day 3 
14.2.3.3.8 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Day 1  
Part 3 
Programming note: Separate plots for Day 1 and Day 3 
14.2.3.3.9 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Linear/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Day 1 and Day 3 
Part 3 
Programming note: Both Day 1 and Day 3 on the same plot 
14.2.3.3.10 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Log10/Linear Scale 
Individual Values for Participant <xxx>: <PK Analysis Set/PK Analysis 
Subset> 
Day 1 and Day 3 
Part 3 
Programming note: Both Day 1 and Day 3 on the same plot 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Figure 
Number 
Figure Title 
 
Statistical Figures 
14.2.4.1.1 
Plasma Pharmacokinetic Parameters: MMV367 
Log10/Log10 Scale 
Geometric Mean (×/÷ Geometric SD) Values by Dose: PK Analysis Set 
Part 1 
<Parameter (units)> 
14.2.4.1.2 
Plasma Pharmacokinetic Parameters: MMV367 
Log10/Log10 Scale 
Individual Values by Dose with Fitted Regression Line: PK Analysis Set 
Part 1 
<Parameter (units)> 
14.2.4.1.3 
Taste Assessment 
Box Plot of Taste Scores by Dose: Taste Analysis Set 
Part 1 
<Taste Aspect> 
14.2.4.1.4 
Taste Assessment 
Bubble Plot of Taste Scores by Dose: Taste Analysis Set 
Part 1 
<Taste Aspect> 
 
 
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20 Index of Listings 
Listing 
Number 
Listing Title 
 
Participant Informed Consent and Completion/Withdrawal 
16.2.1.1 
Participant Informed Consent and Completion/Withdrawal 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.1.2 
Participant Informed Consent and Completion/Withdrawal 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.1.3 
Participant Informed Consent and Completion/Withdrawal 
Individual Values: All Enrolled Subjects 
Part 3 
 
Protocol Deviations and Inclusion/Exclusion Criteria 
16.2.2.1.1 
Protocol Deviations  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.2.1.2 
Inclusion/Exclusion Criteria  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.2.2.1 
Protocol Deviations  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.2.2.2 
Inclusion/Exclusion Criteria  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.2.3.1 
Protocol Deviations  
Individual Values: All Enrolled Subjects 
Part 3 
16.2.2.3.2 
Inclusion/Exclusion Criteria  
Individual Values: All Enrolled Subjects 
Part 3 
 
Analysis Populations and Reasons for Exclusion 
16.2.3.1.1 
Analysis Populations and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.3.1.2 
Analysis Sets and Analysis Subsets and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.3.2.1 
Analysis Populations and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 2 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.3.2.2 
Analysis Sets and Analysis Subsets and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.3.3.1 
Analysis Populations and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 3 
16.2.3.3.2 
Analysis Sets and Analysis Subsets and Reasons for Exclusion  
Individual Values: All Enrolled Subjects 
Part 3 
 
Demographic and Baseline Characteristics 
16.2.4.1.1 
Demographics and Baseline Characteristics 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.2 
Lifestyle Details: Smoking History and Alcohol Consumption  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.3 
Medical/Surgical History  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.4 
Prior and Concomitant Medication 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.5 
Carbon Monoxide Breath Test 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.6 
Urine Drug Screen 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.7 
Alcohol Breath and Carbon Monoxide Test 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.8 
SARS-CoV-2 Antigen Test 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.9 
BDI-II Questionnaire  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.10 
Virology 
Individual Values: All Enrolled Subjects 
Part 1 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.4.1.11 
Creatinine Clearance 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.4.1.12 
Follicle Stimulating Hormone  
Individual Values: All Enrolled Female Subjects 
Part 1 
16.2.4.1.13 
Serum Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 1 
16.2.4.1.14 
Urine Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 1 
16.2.4.2.1 
Demographics and Baseline Characteristics 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.2 
Lifestyle Details: Smoking History and Alcohol Consumption  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.3 
Medical/Surgical History  
Individual Values: All Enrolled Subjects 
Part 12 
16.2.4.2.4 
Prior and Concomitant Medication 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.5 
Carbon Monoxide Breath Test 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.6 
Urine Drug Screen 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.7 
Alcohol Breath and Carbon Monoxide Test 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.8 
SARS-CoV-2 Antigen Test 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.9 
BDI-II Questionnaire  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.10 
Virology 
Individual Values: All Enrolled Subjects 
Part 2 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.4.2.11 
Creatinine Clearance 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.2.12 
Follicle Stimulating Hormone  
Individual Values: All Enrolled Female Subjects 
Part 2 
16.2.4.2.13 
Serum Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 2 
16.2.4.2.14 
Urine Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 2 
16.2.4.2.15 
Body Weight 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.4.3.1 
Demographics and Baseline Characteristics 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.2 
Lifestyle Details: Smoking History and Alcohol Consumption  
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.3 
Medical/Surgical History  
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.4 
Prior and Concomitant Medication 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.5 
Carbon Monoxide Breath Test 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.6 
Urine Drug Screen 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.7 
Alcohol Breath and Carbon Monoxide Test 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.8 
SARS-CoV-2 Antigen Test 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.9 
BDI-II Questionnaire  
Individual Values: All Enrolled Subjects 
Part 3 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.4.3.10 
Virology 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.11 
Creatinine Clearance 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.4.3.12 
Follicle Stimulating Hormone  
Individual Values: All Enrolled Female Subjects 
Part 3 
16.2.4.3.13 
Serum Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 3 
16.2.4.3.14 
Urine Pregnancy Test  
Individual Values: All Enrolled Female Subjects 
Part 3 
 
Dosing Details and Meal Details 
16.2.5.1.1.1 
Dosing Details 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.5.1.1.2 
Meal Details 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.5.1.2.1 
Dosing Details 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.5.1.2.2 
Meal Details 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.5.1.3.1 
Dosing Details 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.5.1.3.2 
Meal Details 
Individual Values: All Enrolled Subjects 
Part 3 
 
Urine Concentration Data 
16.2.5.2.1.1 
Urine Collection Details 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.5.2.1.2 
Excretion: MMV367 
Ae(Urine) (<units>) 
Part 1 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.5.2.1.3 
Excretion: MMV367 
Cumulative Ae(Urine) (<units>) 
Part 1 
16.2.5.2.1.4 
Excretion: MMV367 
Cumulative %Ae(Urine) (<units>) 
Part 1 
16.2.5.2.1.5 
Recovery: MMV367 
Cumulative %Ae(Urine) 
Part 1 
16.2.5.2.1.6 
Recovery: MMV367 
Cumulative Ae(Urine) (<units>) 
Part 1 
16.2.5.2.1.7 
Recovery: MMV367 
Cumulative %Ae(Urine) (<units>) 
Part 1 
 
Plasma Pharmacokinetic Concentration Data 
16.2.5.3.1.1 
Blood Sample Collection Details Pharmacokinetic Analysis, Metabolic 
Profiling and Pharmacogenetic Testing 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.5.3.1.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.5.3.2.1 
Blood Sample Collection Details Pharmacokinetic Analysis, Metabolic 
Profiling and Pharmacogenetic Testing 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.5.3.2.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.5.3.3.1 
Blood Sample Collection Details Pharmacokinetic Analysis, Metabolic 
Profiling and Pharmacogenetic Testing 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.5.3.3.2 
Plasma Pharmacokinetic Concentrations: MMV367 <units> 
Individual Values: All Enrolled Subjects 
Part 3 
 
Plasma Pharmacokinetic Parameter Data 
16.2.6.1 
Plasma Pharmacokinetic Parameters: MMV367 
Individual Values: All Enrolled Subjects 
Part 1 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.6.2 
Plasma Pharmacokinetic Parameters: MMV367 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.6.3 
Plasma Pharmacokinetic Parameters: MMV367 
Individual Values: All Enrolled Subjects 
Part 3 
 
Adverse Events 
16.2.7.1.1 
Pre-dose Adverse Events 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.7.1.2 
All Treatment-Emergent Adverse Events  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.7.1.3 
Serious Adverse Events  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.7.2.1 
Pre-dose Adverse Events 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.7.2.2 
All Treatment-Emergent Adverse Events  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.7.2.3 
Serious Adverse Events  
Individual Values: All Enrolled Subjects 
Part 2 
16.2.7.3.1 
Pre-dose Adverse Events 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.7.3.2 
All Treatment-Emergent Adverse Events  
Individual Values: All Enrolled Subjects 
Part 3 
16.2.7.3.3 
Serious Adverse Events  
Individual Values: All Enrolled Subjects 
Part 3 
 
Laboratory Data 
16.2.8.1.1 
Blood Sample Collection Details for Laboratory Analysis 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.8.1.2 
Haematology and Coagulation 
Individual Values: All Enrolled Subjects 
Part 1 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.8.1.3 
Haematology and Coagulation 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.8.1.4 
Clinical Chemistry 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.8.1.5 
Clinical Chemistry 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.8.1.6 
Urinalysis Sample Collection 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.8.1.7 
Urinalysis 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.8.1.8 
Urinalysis 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.8.2.1 
Blood Sample Collection Details for Laboratory Analysis 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.8.2.2 
Haematology and Coagulation 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.8.2.3 
Haematology and Coagulation 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
16.2.8.2.4 
Clinical Chemistry 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.8.2.5 
Clinical Chemistry 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
16.2.8.2.6 
Urinalysis Sample Collection 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.8.2.7 
Urinalysis 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.8.2.8 
Urinalysis 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.8.3.1 
Blood Sample Collection Details for Laboratory Analysis 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.8.3.2 
Haematology and Coagulation 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.8.3.3 
Haematology and Coagulation 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 3 
16.2.8.3.4 
Clinical Chemistry 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.8.3.5 
Clinical Chemistry 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 3 
16.2.8.3.6 
Urinalysis Sample Collection 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.8.3.7 
Urinalysis 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.8.3.8 
Urinalysis 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 3 
 
Vital Signs and ECGs 
16.2.9.1.1.1 
Vital Signs 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.9.1.1.2 
Vital Signs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.9.1.2.1 
ECGs 
Individual Values: All Enrolled Subjects 
Part 1 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
16.2.9.1.2.2 
ECGs  
Mean Values: All Enrolled Subjects 
Part 1 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.9.1.2.3 
ECGs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.9.1.2.4 
Telemetry 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 1 
16.2.9.2.1.1 
Vital Signs 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.9.2.1.2 
Vital Signs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
16.2.9.2.2.1 
ECGs 
Individual Values: All Enrolled Subjects 
Part 2 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
16.2.9.2.2.2 
ECGs  
Mean Values: All Enrolled Subjects 
Part 2 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
16.2.9.2.2.3 
ECGs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
16.2.9.2.2.4 
Telemetry 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 2 
16.2.9.3.1.1 
Vital Signs 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.9.3.1.2 
Vital Signs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 3 
16.2.9.3.2.1 
ECGs 
Individual Values: All Enrolled Subjects 
Part 3 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
16.2.9.3.2.2 
ECGs  
Mean Values: All Enrolled Subjects 
Part 3 
(Programming note: The order of ECG parameters is to be as per 
Section 11.6) 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Listing 
Number 
Listing Title 
16.2.9.3.2.3 
ECGs 
Individual Values Outside the Reference Range: All Enrolled Subjects 
Part 3 
 
Other Data 
16.2.10.1.1 
Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.10.1.2 
Targeted Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 1 
16.2.10.1.3 
Body Weight Data  
Individual Values: All Enrolled Subjects 
Part 1 
16.2.10.1.3 
Taste Assessment Data 
Individual Values: All Enrolled Subjects 
<Treatment> 
Part 1 
16.2.10.2.1 
Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.10.2.2 
Targeted Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 2 
16.2.10.3.1 
Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.10.3.2 
Targeted Physical Examination Data 
Individual Values: All Enrolled Subjects 
Part 3 
16.2.10.3.3 
Body Weight Data  
Individual Values: All Enrolled Subjects 
Part 3 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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21 Mock Tables 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Page 74 of 128  
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.1.1 
Participant Disposition by Reason 
Summary Statistics: All Enrolled Subjects 
Part 1 
 
                                                                                Active Dose of MMV367 
                                                                     __________________________________________ 
                                       ALL PLACEBO     ALL ACTIVE        100 mg          300 mg          
                                         (N=XX)          (N=XX)          (N=XX)          (N=XX)      .......... 
                                          n (%)           n (%)           n (%)           n (%)                 
 ______________________________________________________________________________________________________________ 
                                                                                                                
 Subjects randomised                    xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
 Subjects dosed                         xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
 Subjects completed                     xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
 Subjects discontinued                  xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                
 Reason for discontinuation                                                                                     
   REASON 1                             xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
   REASON 2                             xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
   REASON 3                             xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
 …                                          …               …               …               …            …      
 <All categories on source>             xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      A participant may be discontinued for 1 reason only.  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all reasons for discontinuation as recorded                                                                
                  on the source. If none of the subjects discontinued from the study early                                                                    
                  then reasons for discontinuation will not be populated in the summary table                                                                 
                  Percentages are based on the number of subjects enrolled                                                                                    
                  A similar table will be produced for Part 3, i.e., Table [14.1.1.3]    
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Page 75 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.1.2 
Participant Disposition by Reason 
Summary Statistics: All Enrolled Subjects 
Part 2 
 
                                   Treatment Sequence                  
                                _________________________              
                                Fed/Fasted    Fasted/Fed    Overall    
                                   (N=X)        (N=X)        (N=X)     
                                   n (%)        n (%)        n (%)     
 _____________________________________________________________________ 
                                                                       
 Subjects randomised             xx (xx.x)    xx (xx.x)    xx (xx.x)   
 Subjects dosed                  xx (xx.x)    xx (xx.x)    xx (xx.x)   
 Subjects completed              xx (xx.x)    xx (xx.x)    xx (xx.x)   
 Subjects discontinued           xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                       
 Reason for discontinuation                                            
   REASON 1                      xx (xx.x)    xx (xx.x)    xx (xx.x)   
   REASON 2                      xx (xx.x)    xx (xx.x)    xx (xx.x)   
   REASON 3                      xx (xx.x)    xx (xx.x)    xx (xx.x)   
   …                                 …            …            …       
   <All categories on source>    xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                       
                                                                       
                                                                       
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      A participant may be discontinued for one reason only                                                                                                   
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all reasons for discontinuation as recorded                                                                
                  on the source. If none of the subjects discontinued from the study early                                                                    
                  then reasons for discontinuation will not be populated in the summary table                                                                 
                  Percentages are based on the number of subjects enrolled in the respective sequence                                                         
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Page 76 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.2.1.2 
Analysis Populations 
Summary Statistics: All Enrolled Subjects 
Part 1 
 
                                                                                               Active Dose of MMV367          
                                                                                      ______________________________________ 
                                                         ALL PLACEBO     ALL ACTIVE       100 mg         300 mg          
                                                            (N=XX)         (N=XX)         (N=XX)         (N=XX)     ........ 
                                                            n (%)          n (%)          n (%)          n (%)               
 ___________________________________________________________________________________________________________________________ 
                                                                                                                             
 Subjects in Safety Population                            xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
   Reasons for exclusion from Safety Population                                                                              
   <All categories from source>                           xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                              …              …              …              …           …     
                                                                                                                             
 Subjects in Taste Population                             xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
   Reasons for exclusion from PK Population                                                                                  
   <All categories from source>                           xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                                             …              …              …           …     
                                                                                                                             
 Subjects in PK Population                                               xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
   Reasons for exclusion from PD Population                                                                                  
   <All categories from source>                                          xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                              …              …              …              …           …     
                                                                                                                             
                                                                                                                             
                                                                                                                             
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      A participant may be excluded for more than 1 reason                                                                                                    
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: Percentages are based on the number of subjects enrolled                                                                                    
                  A similar table will be produced for Part 3, i.e., Table [14.1.2.3.2]     
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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15 Dec 2022 
Page 77 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.2.2.2 
Analysis Populations 
Summary Statistics: All Enrolled Subjects 
Part 2 
  
 
                                                       Treatment Sequence                  
                                                    _________________________              
                                                    Fed/Fasted    Fasted/Fed    Overall    
                                                       (N=X)        (N=X)        (N=X)     
                                                       n (%)        n (%)        n (%)     
 _________________________________________________________________________________________ 
                                                                                           
 Subjects in safety population                       xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Reason for exclusion from safety population                                             
   <All categories on source listing>                xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                         …            …            …       
                                                                                           
 Subjects in PK population                           xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Reason for exclusion from PK population                                                 
   <All categories on source listing>                xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                         …            …            …       
                                                                                           
                                                                                           
                                                                                           
                                                                                           
                                                                                           
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      A participant may be excluded for more than one reason                                                                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: Percentages are based on the number of subjects enrolled in the respective sequence                                                         
                                                                         
                                                                            
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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15 Dec 2022 
Page 78 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.2.1.3 
Safety Analysis Set 
Summary Statistics: Safety Population 
Part 1 
 
                                                                                             Active Dose of MMV367          
                                                                                    ______________________________________ 
                                                       ALL PLACEBO     ALL ACTIVE       100 mg         300 mg          
                                                          (N=XX)         (N=XX)         (N=XX)         (N=XX)     ........ 
                                                          n (%)          n (%)          n (%)          n (%)               
 _________________________________________________________________________________________________________________________ 
                                                                                                                           
 Subjects in safety analysis set                        xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
   Reasons for exclusion from safety analysis set                                                                          
   <All categories from source>                         xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                            …              …              …              …           …     
                                                                                                                           
                                                                                                                           
                                                                                                                           
                                                                                                                           
                                                                                                                           
                                                                                                                           
                                                                                                                           
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      A participant may be excluded for more than 1 reason                                                                                                    
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: A similar table will be produced for the Taste and PK Analysis Sets(and Subsets if applicable), i.e., Tables [14.1.2.1.4]                   
                  and [14.1.2.1.5]. Each analysis set/subset will be a subset of their respective population and percentages                                  
                  will be based on number of subjects in each population                                                                                      
                  Similar tables will be produced for Part 3, i.e., Tables [14.1.2.3.3], [14.1.2.3.4] 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 79 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.2.2.3 
Safety Analysis Set 
Summary Statistics: Safety Population 
Part 2 
 
                                                         XX mg FAST    XX mg FED     Overall    
                                                            (N=X)        (N=X)        (N=X)     
                                                            n (%)        n (%)        n (%)     
 ______________________________________________________________________________________________ 
                                                                                                
 Subjects in safety analysis set                          xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Reasons for exclusion from safety analysis set                                               
   <All categories from source>                           xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                              …            …            …       
                                                                                                
                                                                                                
                                                                                                
                                                                                                
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      A participant may be excluded for more than one reason                                                                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: A similar table will be produced for the PK Analysis Set (and Subset[s], if required), i.e., Table [14.1.2.2.4]                             
                  Each analysis set/subset will be a subset of their respective population and percentages                                                    
                  will be based on number of subjects in each population                                                                                      
                                                       
 
 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 80 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                 Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.3.1 
Demographic and Baseline Characteristics 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                                                             Active Dose of MMV367            
                                                                                  __________________________________________ 
                                                    ALL PLACEBO     ALL ACTIVE        100 mg          300 mg 
                                                      (N=XX)          (N=XX)          (N=XX)          (N=XX)      .......... 
 ___________________________________________________________________________________________________________________________ 
                                                                                                                             
 Age (years)       n                                    xx              xx              xx              xx            …      
                   Mean                                xx.x            xx.x            xx.x            xx.x           …      
                   SD                                  xx.x            xx.x            xx.x            xx.x           …      
                   Median                              xx.x            xx.x            xx.x            xx.x           …      
                   Min                                  xx              xx              xx              xx            …      
                   Max                                  xx              xx              xx              xx            …      
                                                                                                                             
 Ethnicity n(%)    <All categories on source>        xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                             
 Race n(%)         <All categories on source>        xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                             
 Sex n(%)          Male                              xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                   Female                            xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                             
 Height (cm)       …                                     …               …               …               …            …      
                                                                                                                             
 Weight (kg)       …                                     …               …               …               …            …      
                                                                                                                             
 BMI (kg/m^2)      …                                     …               …               …               …            …      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
                                                                                                                                                 
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will continue for all categories of ethnicity and race                                                                           
                  Height, Weight and BMI will be summarised using the same descriptive statistics as Age                                                      
                  If any values are missing, then a “missing” row will be included in the table, as applicable                                                
                  A similar table will be produced for Part 3, i.e., Table [14.1.3.3]            
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 81 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.3.2 
Demographic and Baseline Characteristics 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                                      Treatment Sequence                  
                                                   _________________________              
                                                   Fed/Fasted    Fasted/Fed    Overall    
                                                      (N=X)        (N=X)        (N=X)     
_________________________________________________________________________________________ 
                                                                                          
Age (years)         n                                   xx           xx           xx      
                    Mean                              xx.xx        xx.xx        xx.xx     
                    SD                                xx.xx        xx.xx        xx.xx     
                    Median                            xx.xx        xx.xx        xx.xx     
                    Min                                xx.x         xx.x         xx.x     
                    Max                                xx.x         xx.x         xx.x     
                                                                                          
Ethnicity n(%)      <All categories on source>      xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                          
Race n(%)           <All categories on source>      xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                          
Sex n(%)            Male                            xx (xx.x)    xx (xx.x)    xx (xx.x)   
                    Female                          xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                          
Height (cm)         …                                   …            …            …       
                                                                                          
Weight (kg)         …                                   …            …            …       
                                                                                          
BMI (kg/m^2)        …                                   …            …            …       
                                                                                          
                                                                                          
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will continue for all categories of ethnicity and race                                                                           
                  Height, Weight and BMI will be assessed using the same descriptive statistics as Age                                                        
                  If any values are missing, then a “missing” row will be included in the table, as applicable   
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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15 Dec 2022 
Page 82 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.4.1 
Lifestyle Details: Smoking History and Alcohol Consumption 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                                                              Active Dose of MMV367 
                                                                                   __________________________________________ 
                                                     ALL PLACEBO     ALL ACTIVE        100 mg          300 mg 
                                                       (N=XX)          (N=XX)          (N=XX)          (N=XX)      .......... 
                                                        n (%)           n (%)           n (%)           n (%)                 
 ____________________________________________________________________________________________________________________________ 
                                                                                                                              
 Does the participant smoke (1)   NO                      xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                              PREVIOUSLY              xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                              
 Alcohol Consumption (2)      NONE                    xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                              YES: NOT EXCESSIVE      xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        …      
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
                                                                                                                              
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively  
      (1) Smoked or used e-cigarettes or nicotine replacement products in the last 12 months                                                                  
      (2) Regular alcohol consumption (>21 units/week in males and >14 units/week in females)                                                                 
      1 unit = 1/2 pint beer, 25 mL of 40% spirit, 1.5 to 2 units = 125 mL glass of wine depending on type                                                    
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: A similar table will be produced for Part 3, i.e., Table [14.1.4.3]    
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 83 of 128  
 
 
 
Medicines for Malaria Venture                                                                                             Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.4.2 
Lifestyle Details: Smoking History and Alcohol Consumption 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                                           Treatment Sequence                  
                                                        _________________________              
                                                        Fed/Fasted    Fasted/Fed    Overall    
                                                           (N=X)        (N=X)        (N=X)     
______________________________________________________________________________________________ 
                                                                                               
Does the participant smoke? (1)   NO                         xx (xx.x)    xx (xx.x)    xx (xx.x)   
                              PREVIOUSLY                 xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                               
Alcohol Consumption (2)       NONE                       xx (xx.x)    xx (xx.x)    xx (xx.x)   
                              YES: NOT REGULARLY         xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                               
                                                                                               
                                                                                               
                                                                                               
                                                                                               
                                                                                               
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      (1) Smoked or used e-cigarettes or nicotine replacement products in the last 12 months                                                                  
      (2) Regular alcohol consumption (>21 units/week in males and >14 units/week in females)                                                                 
      1 unit = 1/2 pint beer, 25 mL of 40% spirit, 1.5 to 2 units = 125 mL glass of wine depending on type                                                    
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM        
 
 
 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 84 of 128  
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.5.1 
Extent of Exposure 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                               Subjects Dosed       
                                   (N=XX)           
Treatment                           n (%)           
___________________________________________________ 
                                                    
                                                    
ALL PLACEBO                       xx (xx.x)         
                                                    
ALL ACTIVE                        xx (xx.x)         
                                                    
100 mg                            xx (xx.x)         
                                                    
…                                     …             
                                                    
                                                    
                                                    
                                                    
                                                    
                                                    
                                                    
                                                    
                                                    
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
                                                                                                                                                 
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                
                                                                            
                                                 
                                                                    
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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15 Dec 2022 
Page 85 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.5.2 
Extent of Exposure 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                    Subjects Dosed       
                                         (N=X)           
Treatment                                n (%)           
________________________________________________________ 
                                                         
XX mg FAST                              xx (xx.x)         
XX mg FED                               xx (xx.x)         
                                                         
 
                                                         
                                                         
                                                         
                                                         
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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15 Dec 2022 
Page 86 of 128  
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.1.5.3.1 
Extent of Exposure: Subjects Dosed by Day 
Summary Statistics: Safety Analysis Set 
Part 3 
 
                            ALL PLACEBO       XX mg           XX mg           XX mg            
                              (N=xx)          (N=xx)          (N=xx)          (N=xx)           
Day                            n (%)           n (%)           n (%)           n (%)            
_____________________________________________________________________________________________________ 
                                                                                                          
                                                                                                          
DAY 1                        xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        
                                                                                                          
DAY 2                        xx (xx.x)       xx (xx.x)       xx (xx.x)       xx (xx.x)        
                                                                                                          
…                                …               …               …               …                      
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
                                                                                                          
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo over 3 days                                                     
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
                                                                                                                                                 
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
 
 
 
 
 
                                                                                                                                                              
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 87 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.1.1.1 
Excretion: MM367 
Ae(Urine) by Collection Period <(units)> 
Summary Statistics: PK Analysis Set 
Part 1 
  
MMV367 (N=XX) 
 
Collection Period               n     Mean      SD      CV%   Median    Min     Max   
_____________________________________________________________________________________ 
                                                                                      
PRE-DOSE                        xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME0 - TIME1                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME1 - TIME2                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME2 - TIME3                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
…                               …      …        …        …       …       …       …    
<All other time intervals>      xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
                                                                                      
____________________________________________________________________________________________________________________________                                  
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      Where a participant has failed to void or has a ND concentration over a particular collection interval, the amount                                      
      excreted (Ae) has been set to zero                                                                                                                      
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
(Programming Note: This table will be continued for all collection periods 
                   A similar table will be produced for:                                                 
                   • %Ae(Urine) (Recovery), i.e., Table [14.2.1.1.3]                                                                                          
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 88 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.1.1.2 
Excretion: MMV367 
Cumulative Ae(Urine) <(units)> 
Summary Statistics: PK Analysis Set 
Part 1 
 
MMV367 (N=XX) 
 
Collection Period               n     Mean      SD      CV%   Median    Min     Max   
_____________________________________________________________________________________ 
                                                                                      
PRE-DOSE                        xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME0 - TIME1                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME0 - TIME2                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
TIME0 - TIME3                   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
…                               …      …        …        …       …       …       …    
<All other time intervals>      xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x   
                                                                                      
____________________________________________________________________________________________________________________________                                  
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC205477\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
(Programming note: This table will be continued for all collection periods. If required, as a result of early withdrawal or varying                           
                   follow-up periods, this table will be produced using the LOCF approach. A similar table will be produced for                               
                   • Cumulative %Ae(Urine) (Recovery), i.e., Table [14.2.1.1.4]                                                                               
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 89 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.1.1.5 
Plasma Pharmacokinetic Concentrations: MMV367(<units>) 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 1 
 
                                                             Arithmetic (1)                             Geometric (2)       
                                       ___________________________________________________________ ________________________ 
Treatment                Time Point     n    n#    Mean      SD      CV%   Median    Min     Max     Mean     SD      CV%   
___________________________________________________________________________________________________________________________ 
                                                                                                                            
100 mg                   PRE-DOSE       xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x      NC      NC      NC    
(N=XX)                   TIMEPOINT 1    xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x    xx.xx    xx.xx   xx.x   
                         TIMEPOINT 2    xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x    xx.xx    xx.xx   xx.x   
                         …              …    …      …        …        …       …       …       …       …        …       …    
                                                                                                                            
 
300 mg                   PRE-DOSE       xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x      NC      NC      NC    
(N=XX)                   TIMEPOINT 1    xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x    xx.xx    xx.xx   xx.x   
                         TIMEPOINT 2    xx   xx   xx.xx    xx.xx    xx.x    xx.xx   xx.x    xx.x    xx.xx    xx.xx   xx.x   
                         …              …    …      …        …        …       …       …       …       …        …       …    
                                                                                                                            
…                        …              …    …      …        …        …       …       …       …       …        …       …    
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      n# indicates the number of subjects with a BLQ value recorded at the time point indicated                                                               
      (1) For arithmetic summary statistics, concentration values reported as BLQ have been set to zero                                                       
      (2) For calculation of geometric summary statistics, values reported as BLQ have been set to ½ × LLOQ, except for                                       
      pre-dose values which will not be summarised. The LLOQ value was <value, units>                                                                         
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all treatments and time points                                                                             
   
  
   Similar tables will be produced for Part 2 i.e., Table [14.2.1.2.1] and Part 3 i.e.,[14.2.1.2.3],                                     
                  with a column for Visit included before time point column.  
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 90 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.2.1.1 
Plasma Pharmacokinetic Parameters: MMV367 
Summary Statistics: <PK Analysis Set/PK Analysis Subset> 
Part 1 
 
                                             Parameter 1    Parameter 2    Parameter 3          All Other PK Parameters  
Treatment                   Statistic          (units)        (units)        (units)                    (units)          
________________________________________________________________________________________________________________________ 
                                                                                                                         
100 mg                      n                     xx             xx             xx         …              xx             
(N=XX)                      Mean                 xx.x           xx.x           xx.x        …             xx.x            
                            SD                   xx.x           xx.x           xx.x        …             xx.x            
                            CV%                  xx.x           xx.x           xx.x        …             xx.x            
                            Median               xx.x           xx.x           xx.x        …             xx.x            
                            Min                   xx             xx             xx         …              xx             
                            Max                   xx             xx             xx         …              xx             
                            Geometric Mean       xx.x           xx.x           xx.x        …             xx.x            
                            Geometric SD         xx.x           xx.x           xx.x        …             xx.x            
                            Geometric CV%        xx.x           xx.x           xx.x        …             xx.x            
                                                                                           …                             
300 mg                      …                     …              …              …          …               …             
(N=XX)                      …                     …              …              …          …               …             
                                                                                                                         
…                           …                     …              …              …          …               …             
                                                                                                                         
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo  
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      For concentration parameters, BLQ values will be set to 0 for arithmetic statistics and to ½ × LLOQ for geometric statistics>                           
      The LLOQ value was <value, units                                                                                                                        
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all treatments and PK parameters   
                  Similar tables will be produced for Part 2 i.e., Table [14.2.2.1.2] and Part 3, i.e., Table [14.2.2.1.3]                                    
                  with a column for Visit included before statistic column. 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 91 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.2.2.1 
Plasma Pharmacokinetic Parameters: MMV367 
Statistical Analysis Results - Assessment of Dose Proportionality: <PK Analysis Set/PK Analysis Subset> 
Part 1 
 
                                                               Active Dose of MMV367 
                                          _______________________________________________________________ 
PK                                            100 mg       300 mg     750mg     1500mg     2000mg 
Parameter                                     (N=XX)       (N=XX)     (N=XX)    (N=XX)     (N=XX)      
_________________________________________________________________________________________________________ 
                                                                                                          
Cmax (units)         n                          xx           xx         xx        xx         xx        
                     Geometric Mean            xx.x         xx.x       xx.x      xx.x       xx.x       
                     ß (90% CI)                                        x.xx     (x.xx       x.xx)      
                     2^ß (90% CI)                                      x.xx     (x.xx       x.xx)      
                                                                                                          
AUC (0-last) (units) n                          xx          xx          xx        xx         xx        
                     Geometric Mean            xx.x        xx.x        xx.x      xx.x       xx.x       
                     ß (90% CI)                                        x.xx     (x.xx       x.xx)      
                     2^ß (90% CI)                                      x.xx     (x.xx       x.xx) 
 
AUC (0-inf) (units)  n                          xx          xx          xx        xx         xx        
                     Geometric Mean            xx.x        xx.x        xx.x      xx.x       xx.x       
                     ß (90% CI)                                        x.xx     (x.xx       x.xx)      
                     2^ß (90% CI)                                      x.xx     (x.xx       x.xx)      
      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo over 3 days                                                     
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      Results obtained from log-transformed PK parameters using a power model                                                                                 
      The model includes a term for log dose fitted as a fixed effect                                                                                         
      The geometric means presented are the same as the geometric means presented in Table [14.2.x.x]. N = total number of                                    
      subjects in dose group, n = number of subjects with non-missing, valid data, ß (ie the slope parameter) and its                                         
      90% CI are a measure of dose proportionality, 2^ß represents the increase in exposure for a 2-fold increase in dose                                     
      Dose proportionality can be concluded if the 90% CI for ß lie entirely within the critical region (x.xx, x.xx)                                          
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM            
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 92 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.2.2.2.2 
Plasma Pharmacokinetic Parameters: MMV367 
Statistical Analysis Results - Assessment of Food Effect: <PK Analysis Set/PK Analysis Subset> 
Part 2 
 
                         XX mg FAST       XX mg FED                                                    
                           (N=XX)           (N=XX)                                                       
                     ________________ ________________                                                  
                            Adj Geo          Adj Geo                                                    
                              Mean             Mean    Ratio (%)      90% CI       P-value    CVw (%)   
Parameter              n      (1)       n      (1)        (2)           (3)          (4)        (5)     
_______________________________________________________________________________________________________ 
                                                                                                        
Cmax (units)          xx     xx.xx     xx     xx.xx      xx.xx    (xx.xx, xx.xx)    0.xxx      xx.xxx   
                                                                                                        
AUC(0-last) (units)   xx     xx.xx     xx     xx.xx      xx.xx    (xx.xx, xx.xx)    0.xxx      xx.xxx   
                                                                                                        
AUC(0-inf) (units)    xx     xx.xx     xx     xx.xx      xx.xx    (xx.xx, xx.xx)    0.xxx      xx.xxx   
                                                                                                        
                                                                                                        
                                                                                                        
                                                                                                        
                                                                                                        
                                                                                                        
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      Results obtained from mixed effects model of natural log transformed PK parameters including terms for fed/fasted 
      Status, and period fitted as fixed effects and participant as a random effect                                                   
      (1) Adj geo mean = adjusted geometric mean from model (2) Ratio of adj geo means with comparison presented                                              
      as test/reference (3) CI = confidence interval for ratio of adj geo means (4) p-value from                                                              
      two-sided test (null hypothesis of no difference) (5) CVw = Intra-participant variability                                                               
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 93 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                                                               Active Dose of MMV367     
                                                                                          ______________________________ 
                                                      ALL PLACEBO         ALL ACTIVE            100 mg        .......... 
                                                        (N=XX)              (N=XX)              (N=XX)                   
                                                  ___________________ ___________________ ___________________ __________ 
Event                                                n(%)       E        n(%)       E        n(%)       E     .......... 
________________________________________________________________________________________________________________________ 
                                                                                                                         
TEAEs                                             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
Severe TEAEs                                      xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
IMP-related TEAEs                                 xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
Serious TEAEs                                     xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
TEAEs leading to participant withdrawal               xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
TEAEs leading to death                            xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                                         
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X                                                                                                                      
      n is the number of subjects reporting at least one event                                                                           
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: A similar table will be produced for Part 3, i.e., Table [14.3.3.1]                                                                         
                                            
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
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15 Dec 2022 
Page 94 of 128  
 
 
 
Medicines for Malaria Venture                                                                                             Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                              XX mg FAST           XX mg FED             Overall        
                                                (N=X)                (N=X)                (N=X)         
                                         ____________________ ____________________ ____________________ 
Event                                       n(%)        E        n(%)        E        n(%)        E     
_______________________________________________________________________________________________________ 
                                                                                                        
TEAEs                                      xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
Severe TEAE                                xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
IMP-related TEAEs                          xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
Serious TEAE                               xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
TEAE leading to participant withdrawal     xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
TEAE leading to death                      xx (xx.x)     xx     xx (xx.x)     xx     xx (xx.x)     xx    
                                                                                                        
                                                                                                        
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X                                                                                                                      
      n is the number of subjects reporting at least one event                                                                           
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 95 of 128  
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.1.2 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                                            Active Dose of MMV367      
                                                                       ______________________________ 
                                   ALL PLACEBO         ALL ACTIVE            100 mg                
                                     (N=XX)              (N=XX)              (N=XX)        .......... 
System Organ Class             ___________________ ___________________ ___________________ __________ 
 Preferred Term                   n(%)       E        n(%)       E        n(%)       E     .......... 
_____________________________________________________________________________________________________ 
                                                                                                      
TEAEs                          xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                      
SYSTEM ORGAN CLASS 1           xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 1             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 2             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
etc                            xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                      
SYSTEM ORGAN CLASS 2           xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 1             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 2             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
etc                            xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Subjects experiencing more than one TEAE within a treatment are counted only once for number of subjects                                                
      but will be counted more than once for number of events. Subjects experiencing more than one TEAE within                                                
      a treatment are counted only once within each SOC and PT                                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT                                                                                             
                  A similar table will be produced for Part 3, i.e., Table [14.3.3.2]                                                                         
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 96 of 128  
 
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.2.2 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                         XX mg FAST          XX mg FED            Overall       
                                           (N=X)               (N=X)               (N=X)        
                                    ___________________ ___________________ ___________________ 
                                       n(%)       E        n(%)       E        n(%)       E     
_______________________________________________________________________________________________ 
                                                                                                
TEAEs                               xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
                                                                                                
SYSTEM ORGAN CLASS 1                xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   PREFERRED TERM 1                 xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   PREFERRED TERM 2                 xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   etc                                  …         …         …         …         …         …     
                                                                                                
SYSTEM ORGAN CLASS 2                xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   PREFERRED TERM 1                 xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   PREFERRED TERM 2                 xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx    
   etc                                  …         …         …         …         …         …     
                                                                                                
                                                                                                
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Subjects experiencing more than one TEAE within a treatment are counted only once for number of subjects                                                
      but will be counted more than once for number of events. Subjects experiencing more than one TEAE within                                                
      a treatment are counted only once within each SOC and PT                                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT   
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
Check validity before use


Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 97 of 128  
 
 
 
Medicines for Malaria Venture                                                                                             Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.1.3 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Severity 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                            ALL PLACEBO                             ALL ACTIVE                          
                                               (N=XX)                                 (N=XX)                 .......... 
                               ______________________________________ ______________________________________ __________ 
System Organ Class                 Mild       Moderate      Severe        Mild       Moderate      Severe    .......... 
 Preferred Term                    n(%)         n(%)         n(%)         n(%)         n(%)         n(%)                
_______________________________________________________________________________________________________________________ 
                                                                                                                        
TEAEs                           xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
                                                                                                                        
SYSTEM ORGAN CLASS 1            xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
  PREFERRED TERM 1              xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
  PREFERRED TERM 2              xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
etc                             xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
                                                                                                                        
SYSTEM ORGAN CLASS 2            xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
  PREFERRED TERM 1              xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
  PREFERRED TERM 2              xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
etc                             xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)    xx (xx.x)       …      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Counts are given for total number of subjects, not for events                                                                                           
      Counts of number of subjects are by maximum severity, ie subjects experiencing more than one TEAE within a                                              
      treatment are counted only once within that treatment or each SOC and PT using the most severe episode                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT                                                                                             
                  A similar table will be produced for Part 3, i.e., Table [14.3.3.3]  
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 98 of 128  
 
 
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.2.3 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Severity 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                     XX mg FAST                       XX mg Fed                                      
                                       (N=X)                            (N=X)                                        
                          ________________________________ ________________________________  
                             Mild     Moderate    Severe      Mild     Moderate    Severe       
                             n(%)       n(%)       n(%)       n(%)       n(%)       n(%)        
____________________________________________________________________________________________ 
                                                                                                                             
TEAEs                     xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
                                                                                                                             
SYSTEM ORGAN CLASS 1      xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)    
   PREFERRED TERM 1       xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
   PREFERRED TERM 2       xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
   etc                        …          …          …          …          …          …           
                                                                                                                             
SYSTEM ORGAN CLASS 2      xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
   PREFERRED TERM 1       xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
   PREFERRED TERM 2       xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)  xx (xx.x)   
   etc                        …          …          …          …          …          … 
                                                                                                                             
                                                                                                                             
                                                                                                                             
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Counts are given for total number of subjects, not for events                                                                                           
      Counts of number of subjects are by maximum severity, i.e., subjects experiencing more than one TEAE within a                                           
      treatment are counted only once within that treatment or each SOC and PT using the most severe episode                                                  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 99 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.1.4 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Relationship to IMP 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                        ALL PLACEBO                   ALL ACTIVE                100 mg                                        
                                           (N=XX)                       (N=XX)                  (N=XX)                   ........ 
                               ____________________________ ______________________________ ____________________________ 
                                                                                                         
System Organ Class               Unrelated       Related       Unrelated       Related       Unrelated       Related              
 Preferred Term                     n(%)           n(%)           n(%)           n(%)           n(%)           n(%)      ........ 
_________________________________________________________________________________________________________________________________ 
                                                                                                                                  
TEAEs                            xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                                                                                                  
SYSTEM ORGAN CLASS 1             xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
  PREFERRED TERM 1               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
  PREFERRED TERM 2               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
etc                              xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
                                                                                                                                  
SYSTEM ORGAN CLASS 2             xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
  PREFERRED TERM 1               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
  PREFERRED TERM 2               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
etc                              xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       …     
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Counts are given for total number of subjects, not for events                                                                                           
      Counts of number of subjects are by closest relationship, i.e., subjects experiencing more than one TEAE within a                                       
      treatment are counted only once within that treatment or each SOC and PT using the most closely related event                                           
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT                                                                                             
                  A similar table will be produced for Part 3, i.e., Table [14.3.3.4]                                                                         
                                                                                                
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 100 of 128  
 
 
 
Medicines for Malaria Venture                                                                                           Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.2.4 
Treatment-Emergent Adverse Events 
By MedDRA System Organ Class, Preferred Term and Relationship to IMP 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                         XX mg FAST                    XX mg FED                                                         
                                           (N=XX)                       (N=XX)                       
                               ____________________________ ______________________________  
                                                                                                         
System Organ Class               Unrelated       Related       Unrelated       Related        
 Preferred Term                     n(%)           n(%)           n(%)           n(%)            
___________________________________________________________________________________________ 
                                                                                                                                  
TEAEs                            xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
                                                                                                                                  
SYSTEM ORGAN CLASS 1             xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
  PREFERRED TERM 1               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
  PREFERRED TERM 2               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
etc                              xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
                                                                                                                                  
SYSTEM ORGAN CLASS 2             xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
  PREFERRED TERM 1               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
  PREFERRED TERM 2               xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
etc                              xx (xx.x)      xx (xx.x)      xx (xx.x)      xx (xx.x)       
                                                                                                                     
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                                                   
      Counts are given for total number of subjects, not for events                                                                                           
      Counts of number of subjects are by closest relationship, ie subjects experiencing more than one TEAE within a                                          
      treatment are counted only once within that treatment or each SOC and PT using the most closely related event                                           
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all SOC and PT     
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 101 of 128  
 
 
 
Medicines for Malaria Venture                                                                                             Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.1.5 
Treatment Emergent Adverse Events Related to IMP 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                                            Active Dose of MMV367     
                                                                       ______________________________ 
                                   ALL PLACEBO         ALL ACTIVE            100 mg                
                                     (N=XX)              (N=XX)              (N=XX)        .......... 
System Organ Class             ___________________ ___________________ ___________________ __________ 
 Preferred Term                   n(%)       E        n(%)       E        n(%)       E     .......... 
_____________________________________________________________________________________________________ 
                                                                                                      
TEAEs                           xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                      
SYSTEM ORGAN CLASS 1           xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 1             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 2             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
etc                            xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
                                                                                                      
SYSTEM ORGAN CLASS 2           xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 1             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
  PREFERRED TERM 2             xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
etc                            xx (xx.x)     xx    xx (xx.x)     xx    xx (xx.x)     xx        …      
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                              
      Subjects experiencing more than one TEAE within a treatment are counted only once for number of subjects                                                
      but will be counted more than once for number of events. Subjects experiencing more than one TEAE within                                                
      a treatment are counted only once within each SOC and PT                                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: A similar table will be produced for Serious Adverse Events, i.e., Table [14.3.1.6]                                                         
                  Similar tables will be produced for Part 3, i.e., Tables [14.3.3.5] and [14.3.3.6]   
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 102 of 128  
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.3.2.5 
Treatment Emergent Adverse Events Related to IMP 
By MedDRA System Organ Class and Preferred Term 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                    XX mg FAST          XX mg FED                   
                                      (N=X)               (N=X)                
                               ___________________ ___________________  
                                  n(%)       E        n(%)       E         
_______________________________________________________________________ 
                                                                                           
TEAEs (1)                      xx (xx.x)     xx    xx (xx.x)     xx     
                                                                                           
SYSTEM ORGAN CLASS 1           xx (xx.x)     xx    xx (xx.x)     xx     
   PREFERRED TERM 1            xx (xx.x)     xx    xx (xx.x)     xx     
   PREFERRED TERM 2            xx (xx.x)     xx    xx (xx.x)     xx     
   etc                             …         …         …         … 
                                                                                           
SYSTEM ORGAN CLASS 2           xx (xx.x)     xx    xx (xx.x)     xx     
   PREFERRED TERM 1            xx (xx.x)     xx    xx (xx.x)     xx     
   PREFERRED TERM 2            xx (xx.x)     xx    xx (xx.x)     xx     
   etc                             …         …         …         …         
                                                                                           
                                                                                           
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      E = Total Number of Events                                                                                                                              
      TEAEs are coded using MedDRA vXX.X and are presented in descending order of frequency                                              
      Subjects experiencing more than one TEAE within a treatment are counted only once for number of subjects                                                
      but will be counted more than once for number of events. Subjects experiencing more than one TEAE within                                                
      a treatment are counted only once within each SOC and PT                                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: A similar table will be produced for Serious AEs, i.e., Table [14.3.2.6]                                                                    
                                                              
                                                                                            
                    
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 103 of 128  
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.4.1.1 
Haematology and Coagulation 
Summary Statistics: Safety Analysis Set 
Part 1 
  
<Parameter> (<units>) [ref range xxx-xxx (male), xxx-xxx (female)] 
 
                                               Result                                 Change from Baseline              
                            _____________________________________________ _____________________________________________ 
Treatment     Time Point      n    Mean     SD    Median    Min     Max     n    Mean     SD    Median    Min     Max   
_______________________________________________________________________________________________________________________ 
                                                                                                                        
ALL PLACEBO   BASELINE       xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x                                                 
(N=XX)        TIMEPOINT 1    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
              TIMEPOINT 2    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
              …               …      …       …       …       …       …      …      …       …       …       …       …    
                                                                                                                        
ALL ACTIVE    BASELINE       xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x                                                 
(N=XX)        TIMEPOINT 1    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
              TIMEPOINT 2    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
              …               …      …       …       …       …       …      …      …       …       …       …       …    
                                                                                                                        
…             …               …      …       …       …       …       …      …      …       …       …       …       …    
                                                                                                                        
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      BASELINE is defined as Day -1, Admission                                                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: This table will be continued for all dose levels, time points and parameters                                                                
                  A similar table will be produced for Clinical Chemistry, [14.4.1.3]. Similar tables will be produced for Part 3,                            
                  with a column for Visit included before time point column, i.e., Tables [14.4.3.1] and [14.4.3.3]     
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 104 of 128  
 
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.4.2.1 
Haematology and Coagulation 
Summary Statistics: Safety Analysis Set 
Part 2 
  
<Parameter> (<units>) [ref range xxx-xxx (male), xxx-xxx (female)] 
 
                                                         Result                                Change from Baseline             
                                      ____________________________________________ ____________________________________________ 
Treatment   Time Point                 n    Mean     SD    Median    Min     Max    n    Mean     SD    Median    Min     Max   
_______________________________________________________________________________________________________________________________ 
                                                                                                                                
XX mg FAST  BASELINE                   xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x                                                
(N=X)       TIME POINT 1               xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
            TIME POINT 2               xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
            …                          …      …       …       …       …       …     …      …       …       …       …       …    
            <All other time points>    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
                                                                                                                                
XX mg FED   BASELINE                   xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x                                                
(N=X)       TIME POINT 1               xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
            TIME POINT 2               xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
            …                          …      …       …       …       …       …     …      …       …       …       …       …    
            <All other time points>    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx   xx.xx   xx.xx   xx.xx   xx.x    xx.x   
                                                                                                                                
                                                                                                                                
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      BASELINE is defined as Day -1, Admission  
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all haematology <and coagulation> parameters and all time points                                           
                  A similar table will be produced for Clinical Chemistry, i.e., Table [14.4.2.3]         
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 105 of 128  
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.4.1.2 
Haematology and Coagulation 
Shift Analysis: Safety Analysis Set 
Part 1 
  
<Parameter> (<units>) [ref range xxx-xxx (male), xxx-xxx (female)] 
 
                                                          Baseline                
                                           ______________________________________ 
                 Time Point                   Below        Within       Above     
Treatment           Assessment        N#       n(%)         n(%)         n(%)     
_________________________________________________________________________________ 
                                                                                  
ALL PLACEBO      TIMEPOINT 1          xx                                          
(N=XX)              Below                   xx (xx.x)    xx (xx.x)    xx (xx.x)   
                    Within                  xx (xx.x)    xx (xx.x)    xx (xx.x)   
                    Above                   xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                  
                 …                     …        …            …            …       
                                                                                  
ALL ACTIVE       TIMEPOINT 1          xx                                          
(N=XX)              Below                   xx (xx.x)    xx (xx.x)    xx (xx.x)   
                    Within                  xx (xx.x)    xx (xx.x)    xx (xx.x)   
                    Above                   xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                   
…                …                     …        …            …            …       
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      BASELINE is defined as Day -1, Admission                                                                                                                
      N# is the total number of subjects that have a value at baseline and the relevant time point and is used in the denominator                             
      for calculating the percentages of subjects, n indicates the number of subjects with a baseline and a post baseline                                     
      assessment at the time point indicated. Below/within/above indicate the n (%) of subjects with assessments                                              
      below/within/above the normal reference range                                                                                                           
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: Continue this table for all dose levels, time points and parameters                                                                         
                  A similar table will be produced for Clinical Chemistry, [14.4.1.4]. Similar tables will be produced for Part 3,                            
                  with a column for Visit included before time point column, i.e., Tables [14.4.3.2] and [14.4.3.4]   
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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15 Dec 2022 
Page 106 of 128  
 
 
 
                                               
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.4.2.2 
Haematology and Coagulation 
Shift Analysis: Safety Analysis Set 
Part 2 
  
<Parameter> (<units>) [ref range xxx-xxx (male), xxx-xxx (female)] 
 
                                            XX mg FAST                                    XX mg FED                
                                              (N=X)                                        (N=X)                  
                                             Baseline                                     Baseline                
                              ______________________________________       ______________________________________ 
Time Point                       Below        Within       Above              Below        Within       Above     
   Assessment            N#       n(%)         n(%)         n(%)      N#       n(%)         n(%)         n(%)     
_________________________________________________________________________________________________________________ 
                                                                                                                  
TIME POINT 1             xx                                           xx                                          
   Below                       xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Within                      xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Above                       xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                                                  
TIME POINT 2             xx                                           xx                                          
   Below                       xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Within                      xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
   Above                       xx (xx.x)    xx (xx.x)    xx (xx.x)          xx (xx.x)    xx (xx.x)    xx (xx.x)   
                                                                                                                  
<All other time points>   …                                                                                       
                                   …            …            …         …        …            …            …       
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      BASELINE is defined as Day -1, Admission of the corresponding study period                                                                              
      N# indicates the number of subjects with a baseline and a post baseline assessment at the time point indicated                                          
      Below/within/above indicate the n(%)=number(%) of subjects with assessments below/within/above the                                                      
      normal reference range at baseline                                                                                                                      
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all haematology and coagulation parameters and all time points                                             
                  A similar table will be produced for Clinical Chemistry, i.e., Table [14.4.2.4]    
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 107 of 128  
 
 
 
Medicines for Malaria Venture                                                                                             Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.1.1 
Vital Signs 
Summary Statistics: Safety Analysis Set 
Part 1 
  
<Parameter> (<units>) [ref range xxx - xxx (age xx - xx), xxx - xxx (age > xx)] 
 
                                                                                   Change from                  Substantial   
                                           Result                                   Baseline                      Change      
                          _________________________________________ _________________________________________ _______________ 
Treatment    Time Point    n    Mean     SD    Median  Min    Max    n    Mean     SD    Median  Min    Max   DEC  NONE  INC  
_____________________________________________________________________________________________________________________________ 
                                                                                                                              
ALL PLACEBO  BASELINE      xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x                                                            
(N=XX)       TIMEPOINT 1   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx    xx  
             TIMEPOINT 2   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx    xx  
             …             …      …       …      …      …      …     …      …       …      …      …      …     …     …    …   
                                                                                                                              
ALL ACTIVE   BASELINE      xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x                                                            
(N=XX)       TIMEPOINT 1   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx    xx  
             TIMEPOINT 2   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx.xx   xx.xx  xx.xx   xx.x   xx.x   xx   xx    xx  
             …             …      …       …      …      …      …     …      …       …      …      …      …     …     …    …   
                                                                                                                              
…            …             …      …       …      …      …      …     …      …       …      …      …      …     …     …    …   
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      BASELINE is defined as Day 1, Pre-dose                                                                                                                  
      Substantial change is defined as: > ± 20 mmHg Systolic BP, > ± 10 mmHg Diastolic BP and > ± 15 bpm HR                                                   
      DEC: number of subjects with substantial decrease from baseline NONE: number of subjects with no substantial                                            
      change from baseline, INC: number of subjects with substantial increase from baseline                                                                   
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
                                                                                                                                                              
Programming note: Continue this table for all dose levels, time points and parameters (which will follow the order given in the RAP text)                     
                  A similar table will be produced for Part 3, with a column for Visit included before time point                                             
                  column, i.e., Table [14.5.1.3]  
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 108 of 128  
 
 
 
Medicines for Malaria Venture                                                                                            Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.1.2 
Vital Signs 
Summary Statistics: Safety Analysis Set 
Part 2 
  
<Parameter> (<units>) [ref range xxx - xxx (age xx - xx), xxx - xxx (age > xx)] 
 
                                                                                            Change from               Substantial  
                                                        Result                                Baseline                 Change (1)  
                                        ______________________________________ ______________________________________ ____________ 
Treatment      Time Point                n   Mean    SD    Median   Min   Max   n   Mean    SD    Median   Min   Max  DEC NONE INC 
__________________________________________________________________________________________________________________________________ 
                                                                                                                                   
XX mg FAST     BASELINE                 xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x                                                      
(N=X)          TIME POINT 1             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               TIME POINT 2             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               TIME POINT 3             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               …                         …    …      …       …       …     …    …    …      …       …       …     …    …   …    …  
               <All other time points>  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
                                                                                                                                   
XX mg FED      BASELINE                 xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x                                                      
(N=X)          TIME POINT 1             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               TIME POINT 2             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               TIME POINT 3             xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
               …                         …    …      …       …       …     …    …    …      …       …       …     …    …   …    …  
               <All other time points>  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx  xx.xx  xx.xx   xx.xx   xx.x  xx.x  xx   xx  xx  
                                                                                                                                   
                                                                                                                                   
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      BASELINE is defined as Day 1, Pre-dose of the corresponding study period                                                                                
      Substantial change is defined as: > ± 20 mmHg Systolic BP, > ± 10 mmHg Diastolic BP and > ± 15 bpm HR                                                   
      DEC: number of subjects with substantial decrease from baseline NONE: number of subjects with no substantial                                            
      change from baseline, INC: number of subjects with substantial increase from baseline                                                                   
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all vital signs parameters, which will follow the order given in the RAP text  
   
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 109 of 128  
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.2.1.1 
ECGs 
Summary Statistics: Safety Analysis Set 
Single 12-Lead 
Part 1 
  
<Parameter> (<units>) [<ref range xxx - xxx (age xx - xx), xxx - xxx (age > xx)> / <ref range xxx - xxx (male), xxx-xxx (female)>] 
 
                                                  Result                                 Change from Baseline              
                               _____________________________________________ _____________________________________________ 
Treatment      Time Point        n    Mean     SD    Median    Min     Max     n    Mean     SD    Median    Min     Max   
__________________________________________________________________________________________________________________________ 
                                                                                                                           
ALL PLACEBO    BASELINE         xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x                                                 
(N=XX)         TIMEPOINT 1      xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
               TIMEPOINT 2      xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
               …                 …      …       …       …       …       …      …      …       …       …       …       …    
                                                                                                                           
ALL ACTIVE     BASELINE         xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
(N=XX)         TIMEPOINT 1      xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
               TIMEPOINT 2      xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx   xx.x    xx.x   
               …                 …      …       …       …       …       …      …      …       …       …       …       …    
                                                                                                                           
…              …                 …      …       …       …       …       …      …      …       …       …       …       …    
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      BASELINE is defined as Day 1, mean of 3 Pre-dose measurements                                                                                           
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all dose levels, time points and parameters (which will follow 
                  the order given in the RAP text)                        
                  A similar table will be produced for triplicate readings i.e., Table [14.5.2.1.2] 
                  Similar tables will also be produced for Part 3, with a column for Visit included before time point                                         
                  column, i.e., Tables [14.5.2.3.1] and [14.5.2.3.2] 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 110 of 128  
 
 
 
Medicines for Malaria Venture                                                                                               Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.2.2.1 
ECGs 
Summary Statistics: Safety Analysis Set 
Single 12-Lead 
Part 2 
  
<Parameter> (<units>) [<ref range xxx - xxx (age xx - xx), xxx - xxx (age > xx)> / <ref range xxx - xxx (male), xxx-xxx (female)>] 
 
                                                         Result                                  Change from Baseline              
                                     ______________________________________________ ______________________________________________ 
Treatment   Time Point                 n    Mean     SD     Median    Min     Max     n    Mean     SD     Median    Min     Max   
__________________________________________________________________________________________________________________________________ 
                                                                                                                                   
XX mg FAST   BASELINE                 xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x                                                  
(N=X)       TIME POINT 1              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            TIME POINT 2              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            TIME POINT 3              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            …                          …      …       …       …        …       …      …      …       …       …        …       …    
            <All other time points>   xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
                                                                                                                                       
XX MG FED   BASELINE                  xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x                                                  
(N=X)       TIME POINT 1              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            TIME POINT 2              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            TIME POINT 3              xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
            …                          …      …       …       …        …       …      …      …       …       …        …       …    
            <All other time points>   xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x    xx    xx.xx   xx.xx   xx.xx    xx.x    xx.x   
                                                                                                                                   
                                                                                                                                   
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      BASELINE is defined as Day 1, Pre-dose of the corresponding study period                                                                                
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all ECG parameters, which will follow the order given in the RAP text  
                  A similar table will be produced for triplicate readings i.e., Table [14.5.2.2.2]                                        
                                                                                                                 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 111 of 128  
 
 
 
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.2.1.3 
ECGs 
QTcB and QTcF Categorical Data 
Summary Statistics: Safety Analysis Set 
Part 1 
 
                                                          QTcF                                    QTcF Interval             
                                                     Interval (msec)                             Increase (msec)             … 
                                   ___________________________________________________ ____________________________________ 
                                     <=450       451-480        481-500        >500       =<30         31-60         >60     
Treatment     Time Point      N#      n(%)         n(%)           n(%)         n(%)       n(%)         n(%)         n(%)     …  
___________________________________________________________________________________________________________________________ 
                                                                                                                            
ALL PLACEBO   BASELINE        xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)                                       
(N=XX)        TIMEPOINT 1     xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)   … 
              TIMEPOINT 2     xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)   … 
              …                …       …            …              …            …          …            …            …      
                                                                                                                            
ALL ACTIVE    BASELINE        xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)   …  
(N=XX)        TIMEPOINT 1     xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)   … 
              TIMEPOINT 2     xx   xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)   …  
              …                …       …            …              …            …          …            …            …      
                                                                                                                            
…             …                …       …            …              …            …          …            …            …       …  
                                                                                                                            
                                                                                                                            
                                                                                                                            
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo                                                                 
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
                                                                                                                                                 
      BASELINE is defined as Day 1, Pre-dose                                                                                                                  
      Categories for QTcF interval and QTcF interval increases are based on ICH E14 guidelines                                                                
      N# is the total number of subjects at the relevant time point and is used in the denominator for calculating                                            
      the percentages of subjects, n indicates the number of subjects with observations at the given time point                                               
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for QTcB 
                  A similar table will be produced for Part 3, with a column for Visit included before time point                                             
                  column, i.e., Table [14.5.2.3.3]                                                                                                            
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 112 of 128  
 
 
 
                                                                                                                                                              
Medicines for Malaria Venture                                                                                                Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.5.2.2.3 
ECGs 
QTcB and QTcF Categorical Data 
Summary Statistics: Safety Analysis Set 
Part 2 
 
                                                                 QTcF                                    QTcF Interval             
                                                            Interval (msec)                             Increase (msec)            … 
                                          ___________________________________________________ ____________________________________ 
                                            <=450       451-480        481-500        >500       <=30        31-60         >60     
Treatment   Time Point                N#     n(%)         n(%)           n(%)         n(%)       n(%)         n(%)         n(%)    …  
__________________________________________________________________________________________________________________________________ 
                                                                                                                                   
XX mg FAST  BASELINE                      xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)                                       
(N=X)       TIME POINT 1              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
            TIME POINT 2              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  …  
            TIME POINT 3              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
            …                         …       …            …              …            …          …            …            …      
            <All other time points>   xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
                                                                                                                                   
XX mg FED   BASELINE                      xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)                                       
(N=X)       TIME POINT 1              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
            TIME POINT 2              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
            TIME POINT 3              xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
            …                         …       …            …              …            …          …            …            …      
            <All other time points>   xx  xx (xx.x)    xx (xx.x)      xx (xx.x)    xx (xx.x)  xx (xx.x)    xx (xx.x)    xx (xx.x)  … 
                                                                                                                                   
                                                                                                                                   
                                                                                                                                   
__________________________________________________________________________________________________________________________________                            
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were to receive both treatments (i.e., Regimen 6 and Regimen 7) in a randomised manner                                                     
      over the two separate dosing occasions                                                                                                                  
      BASELINE is defined as Day 1, Pre-dose of the corresponding study period                                                                                
      Categories for QTcF interval and QTcF interval increases are based on ICH E14 guidelines                                                                
      N# is the number of subjects with a value at baseline and the relevant post-dose time point. It is the denominator for                                  
      calculating the percentages of subjects, n indicates the number of subjects with observations at the given time point                                   
                                                                                                                                                              
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM     
 
Programming note: This table will be continued for QTcB                                                   
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
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15 Dec 2022 
Page 113 of 128  
 
 
 
Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.6.1.1 
Taste Assessments: Taste Aspect 
Summary Statistics: Taste Analysis Set 
Part 1 
 
<Taste Aspect> 
 
                                                           MMV367 
                                        ______________________________________________ 
                      Pooled Placebo           100 mg               300 mg 
Statistic                 (N=XX)               (N=XX)               (N=XX)        .... 
______________________________________________________________________________________ 
                                                                                       
n                           xx                   xx                   xx           …   
Mean                       xx.x                 xx.x                 xx.x          …   
SD                         xx.x                 xx.x                 xx.x          …   
Median                     xx.x                 xx.x                 xx.x          …   
Min                        xx.x                 xx.x                 xx.x          …   
Max                        xx.x                 xx.x                 xx.x          …   
                                                                                       
GRADE 1 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 2 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 3 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 4 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 5 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 6 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 7 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 8 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
GRADE 9 n (%)           xx (xx.x)            xx (xx.x)            xx (xx.x)        …   
 
____________________________________________________________________________________________________________________________                                  
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo  
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
      Key for grade: 1=Dislike extremely, 2=Dislike very much, 3=Dislike moderately, 4=Dislike slightly,                                                      
      5=Neither like nor dislike, 6=Like slightly, 7=Like moderately, 8=Like very much, 9=Like extremely   
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
                                                                                                                                                              
Programming note: This table will be continued for all dose levels. 
                  A separate page will be used for each taste aspect with the relevant subheading   
                  A similar table will be produced for Overall Acceptability, i.e., Table [14.6.1.2]                                                          
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Medicines for Malaria Venture                                                                                              Page x of y 
Protocol: MMV_MMV367_21_01 
 
TABLE 14.6.1.3 
Taste Assessments: Taste Aspects including Overall Acceptability 
Statistical Analysis Results: Taste Analysis Set 
Part 1 
 
Wilcoxon Rank Sum Test: <Taste Aspect> 
 
                         Test              Reference                                                  
                 ___________________ ___________________   Difference       90% CI         p-value  
Comparison         n       Median      n       Median          (1)            (2)            (3)    
_________________________________________________________________________________________________ 
                                                                                                  
100 mg  vs         xx       xxx        xx       xxx           xxx         (xx.xx, xx.xx)     0.xxx   
Pooled Placebo                                                                                       
                                                                                                  
300 mg  vs         xx       xxx        xx       xxx           xxx         (xx.xx, xx.xx)     0.xxx   
Pooled Placebo                                                                                      
…                  …         …         …         …             …                …              …     
 
 
 
 
 
 
____________________________________________________________________________________________________________________________                                  
Note: The data in this table are presented in listing x.x                                                                                                     
      All subjects were planned to receive a single dose of either MMV367 or matching placebo  
      All Placebo/All Active relate to placebo or active subjects pooled over all cohorts, respectively                                                       
Results obtained from non-parametric Wilcoxon rank sum test                                                                                            
(1) Hodges-Lehmann median difference for test (Regimens 1 to 5 – Pooled Placebo), (2) Confidence interval for Hodges-Lehmann median  
difference (3) p-value from Wilcoxon rank sum test for the null hypothesis that the Hodges-Lehmann median difference is zero                            
      Hodges-Lehmann median difference is not necessarily the same as the difference between medians  
                                                            
                                                                                                                                                              
PROGRAM PATH: X:\~\QSC207031\~\TFLS\PRODUCTION\TAB-XX                                      DDMMMYYYY HH:MM                                                    
 
                                                                                                                                                              
Programming note: This table will be continued for all dose level comparisons  
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 1 
Schedule of Assessments: Part 1 (Cohorts 1A to 1E) 
Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb 
End of Study 
Visitb 
-28 to -2 
-1 
1 
2 
3 
4 
5a 
7 
15 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
Xd 
Xd 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath Test 
X 
X 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
Targeted (symptom driven) Physical 
Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
X 
 
 
X 
X 
X 
Urinalysisi 
X 
X 
 
X 
 
 
X 
X 
X 
Follicle-stimulating Hormone (FSH) Testj 
X 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
X 
X 
Single 12-Lead ECGsl 
X 
X 
X 
X 
 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
 
X 
X 
X 
X 
 
Holter Periodsm 
  
 
X 
X 
 
 
 
 
 
Telemetryn 
 
 
X 
 
 
 
 
 
 
Vital Signso 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Orthostatic Vital Signso 
X 
 
X 
X 
 
 
 
X 
 
Adverse Events 
< ---------------------------------------------------------------------------X--------------------------------------------------------------------------> 
Prior and Concomitant Medication 
< ---------------------------------------------------------------------------X------------------------------------------------------------------------ > 
PK/Metabolite ID/Pharmacogenetic Assessments 
Plasma Samples for MMV367p 
 
 
X 
X 
X 
X 
X 
X 
 
Urine Samples for MMV367pq 
 
 
X 
X 
X 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Study Day 
Screening Admission 
Resident In-clinic 
Return Visitb 
End of Study 
Visitb 
-28 to -2 
-1 
1 
2 
3 
4 
5a 
7 
15 
Blood Sample for CYP/UGT 
polymorphismr 
 
 
X 
 
 
 
 
 
 
Taste/Palatability Assessments 
Taste/Palatability Questionnaires 
 
 
 
 
 
 
 
 
 
 
Eligibility will be re-assessed at admission/pre-dose on Day 1. 
a Discharge from clinical unit 
b Participants will return for an outpatient visit on Day 7 and an end of study visit on Day 15 (±1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 testing 
time points are participant to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the Clinical Kick-
Off Meeting minutes. 
f Participants will be randomised on the morning of Day 1 prior to dosing 
g Participants will receive a single dose of MMV367 or placebo on Day 1 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation and clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at screening. 
See study protocol for safety blood sample time points. 
j Post-menopausal female participants only 
k All female participants 
l See study protocol for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external stimuli 
(e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position with no 
external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See study protocol for Holter extraction time 
points. 
n Telemetry (continuous ECG monitoring) will commence at least 30 min before dosing until at least 12 h post-dose. 
o Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening/admission only. See study protocol for vital signs and 
orthostatic vital signs time points. 
p See study protocol for PK sample time points. Metabolite profiling of MMV367 in plasma and urine will be performed using existing PK samples (pooled residual samples). 
q Urine collection in Cohorts 1C and 1D only. 
r Sample will be taken prior to IMP administration (≤2 h before dosing). 
sThe taste/palatability questionnaire will be completed immediately after IMP administration, see study protocol for details. 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 2 
Schedule of Assessments: Part 2 
 
 
 
Resident in Clinic 
End of Study 
Visit 
Study Day 
Screening 
Admi-
ssion 
Period 1 
Period 2 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12a 
14b 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted (symptom driven) 
Physical Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
 
 
X 
X 
Urinalysisi 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
 
 
X 
X 
Follicle-stimulating Hormone 
(FSH) Testj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Single 12-Lead ECGsl 
X 
X 
X 
X 
 
 
 
 
 
X 
X 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
 
Holter Periodsm 
 
 
X 
X 
 
 
 
 
 
X 
X 
 
 
 
 
Telemetryn 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Vital Signso 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
< --------------------------------------------------------------------------X----------------------------------------------------------------------- > 
Prior and Concomitant 
Medication 
< --------------------------------------------------------------------------X----------------------------------------------------------------------- > 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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PK/Pharmacogenetic Assessments 
Plasma Samples for 
MMV367p 
 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Blood Sample for CYP/UGT 
polymorphismq 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility will be re-assessed at admission/pre-dose on Day 1.  
a Discharge from clinical unit 
b Participants will return for an end of study visit on Day 14 (± 1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 testing 
time points are participant to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the Clinical Kick-
Off Meeting minutes. 
f Participants will be randomised on the morning of Period 1, Day 1 prior to dosing 
g Participants will receive a single dose of MMV367 on Day 1 and Day 8 in the fed or fasted state 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation, clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at screening. 
j Post-menopausal female participants only 
k All female participants 
l See study protocol for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external stimuli 
(e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position with no 
external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See study protocol for Holter extraction time 
points. 
n Telemetry (continuous ECG monitoring) will commence at least 30 min before dosing until at least 12 h post-dose. 
o Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening and admission only. See study protocol for vital signs 
time points. 
p See study protocol for PK sample time points. 
q Sample will be taken prior to IMP administration (≤2 h before dosing). 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 3 
Schedule of Assessments: Part 3 (Cohorts 3A to 3C) 
Study Day 
Screening 
Admission 
Resident In-clinic 
Return Visitb 
End of Study 
Visitb 
 
-28 to -2 
-1 
1 
2 
3 
4 
5 
6 
7a 
9 
17 
General Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xc 
 
 
 
 
 
 
 
 
 
Weight, Height and BMI 
X 
Xd 
 
 
 
 
 
 
 
Xd 
Xd 
Vein Assessment 
X 
 
 
 
 
 
 
 
 
 
 
Carbon Monoxide Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
Drug Screen 
X 
X 
 
 
 
 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 Antigene 
X 
X 
 
 
 
 
 
 
 
 
 
Randomisationf 
 
 
X 
 
 
 
 
 
 
 
 
IMP Administrationg 
 
 
X 
X 
X 
 
 
 
 
 
 
Safety Assessments 
BDI-II Questionnaire 
X 
X 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
X 
 
 
 
 
 
 
 
 
 
Targeted (symptom driven) Physical 
Examinationh 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety Labsi 
X 
X 
 
 
X 
 
X 
 
X 
X 
X 
Urinalysisi 
X 
X 
 
 
X 
 
X 
 
X 
X 
X 
Follicle-stimulating Hormone (FSH) 
Testj 
X 
 
 
 
 
 
 
 
 
 
 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Testk 
 
X 
 
 
 
 
 
 
 
X 
X 
Single 12-Lead ECGsl 
X 
X 
X 
 
X 
X 
 
 
 
 
X 
Triplicate 12-Lead ECGsl 
 
 
 
X 
 
X 
X 
X 
X 
X 
 
Holter Periodsm 
 
 
X 
X 
X 
X 
 
 
 
 
 
Vital Signsn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Orthostatic Vital Signsn 
X 
 
X 
X 
X 
X 
 
 
 
X 
 
Adverse Events 
< ------------------------------------------------------------------------X------------------------------------------------------------------ > 
Prior and Concomitant Medication 
< ------------------------------------------------------------------------X------------------------------------------------------------------ > 
PK/Pharmacogenetic Assessments 
Plasma Samples for MMV367o 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Blood Sample for CYP/UGT 
polymorphismp 
 
 
X 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Eligibility will be re-assessed at admission/pre-dose on Day 1. 
a Discharge from clinical unit 
b Participants will return for an outpatient visit on Day 9 and an end of study visit on Day 17 (± 1 day). 
c Update only 
d Weight only 
e It is planned that testing will comprise an antigen test performed at screening and on Day -1 prior to admission to the clinical unit. The definition of the COVID-19 testing 
time points are participant to change based on the current risk mitigation in place and will be agreed by the study team and documented in the ISF via the Clinical Kick-
Off Meeting minutes. 
f Participants will be randomised on the morning of Day 1 prior to dosing 
g Participants will receive a dose of MMV367 or placebo in the morning on Days 1, 2 and 3 
h Targeted (symptom driven) physical examination of the relevant body system(s) as clinically indicated, as per the investigator’s judgement 
i Haematology, coagulation, clinical chemistry and urinalysis at each time point, including virology and FSH (post-menopausal female participants only) at screening. 
j Post-menopausal female participants only 
k All female participants 
l See study protocol for single and triplicate 12-lead ECG time points. For triplicate ECGs, participants will be required to rest in the supine position with no external stimuli 
(e.g. music or television) for 15 min prior to the nominal time point where a triplicate ECG is scheduled. 
m Continuous Holter monitoring will commence at least 1.5 h prior to dosing until at least 24 h post-dose. Participants will be required to rest in the supine position with no 
external stimuli (e.g. music or television) for 15 min prior to the nominal time point where an ECG extraction is scheduled. See study protocol for Holter extraction time 
points. 
n Blood pressure, heart rate and respiratory rate at all time points. Oral temperature will be measured at screening and admission only. See study protocol for vital signs 
and orthostatic vital signs time points. 
o See study protocol for PK sample time points. 
p Sample will be taken prior to IMP administration (≤2 h before dosing). 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 4      Part 1 (All Cohorts) Safety and Pharmacokinetic Assessment Time Points (Days 1 to 7) 
Study Day 
Time point 
Plasma 
PK 
Urine PKa 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital 
Signsb 
Orthostatic 
Vital Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
 
X 
 
 
X 
 
-1 h 
 
 
 
X 
 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
X 
 
X 
X 
X 
X 
 
0 h 
 
0 to 6 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
 
X 
 
1 h 
X 
 
X 
 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
X 
 
6 h 
X 
6 to 12 h 
 
X 
X 
 
X 
 
8 h 
X 
 
X 
X 
 
X 
 
10 h 
 
 
 
X 
 
 
 
12 h 
X 
12 to 24 h 
 
X 
X 
X 
X 
 
2 
24 h 
X 
24 to 48 h 
X 
X 
X 
X 
X 
 
3 
48 h 
X 
48 to 72 h 
 
 
X 
 
 
X 
4 
72 h 
X 
 
 
 
X 
 
 
X 
5 
96 h 
X 
 
X 
 
X 
 
 
X 
7 
144 h 
X 
 
X 
 
X 
X 
 
X 
a Part 1, Cohorts 1C and 1D only 
b Blood pressure, heart rate and respiratory rate at all time points. 
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Section 13.1, 14.6 and 14.7 of the study 
protocol. 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 5 
Part 2 Safety and Pharmacokinetic Assessment Time Points (Days 1 to 14) 
Study Day 
Time point 
Plasma 
PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
X 
 
X 
 
-1 h 
 
 
X 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
X 
 
1 h 
X 
 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
 
3 h 
X 
 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
8 h 
X 
 
X 
X 
X 
 
10 h 
 
 
 
X 
 
 
12 h 
X 
 
X 
X 
X 
 
2 
24 h 
X 
X 
X 
X 
X 
 
3 
48 h 
X 
 
 
X 
 
X 
4 
72 h 
X 
 
 
X 
 
X 
5 
96 h 
X 
X 
 
X 
 
X 
7 
144 h 
X 
X 
 
X 
 
X 
8 
-1.5 h 
 
 
X 
 
X 
 
-1 h 
 
 
X 
 
X 
 
Pre-dose 
(-0.5 h) 
X 
 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
X 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Study Day 
Time point 
Plasma 
PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 h 
X 
 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
 
3 h 
X 
 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
8 h 
X 
 
X 
X 
X 
 
10 h 
 
 
 
X 
 
 
12 h 
X 
 
X 
X 
X 
 
9 
24 h 
X 
X 
X 
X 
X 
 
10 
48 h 
X 
 
 
X 
 
X 
11 
72 h 
X 
 
 
X 
 
X 
12 
96 h 
X 
X 
 
X 
 
X 
14 
144 h 
X 
X 
 
X 
 
X 
a Blood pressure, heart rate and respiratory rate at all time points. 
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Sections 13.1, 14.6 and 14.7 of the study 
protocol. 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
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Appendix 6 
Part 3 Safety and Pharmacokinetic Assessment Time Points (Days 1 to 9) 
Study Day 
Time point 
Plasma PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Orthostatic Vital 
Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
1 
-1.5 h 
 
 
X 
 
 
X 
 
-1 h 
 
 
X 
 
 
X 
 
Pre-dose (-0.5 h) 
X 
 
X 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
 
0.5 h 
X 
 
X 
 
 
 
 
1 h 
X 
 
X 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
X 
 
8 h 
X 
 
X 
X 
 
X 
 
10 h 
 
 
X 
X 
 
 
 
11 h 
 
 
 
 
 
 
 
12 h 
X 
 
X 
X 
X 
X 
 
2 
-1.5 h 
 
 
 
 
 
 
X 
-1 h 
 
 
 
 
 
 
X 
Pre-dose (-0.5 h)b 
X 
 
X (Day 1, 24 h) 
X 
X (Day 1, 24 h) 
 
X 
0 h 
 
 
 
 
 
 
 
1 h 
 
 
 
 
 
 
 
2 h 
 
 
 
 
 
 
 
3 h 
 
 
 
 
 
 
 
4 h 
X 
 
 
X 
 
 
X 
5 h 
 
 
 
 
 
 
 
6 h 
X 
 
 
X 
 
 
X 
7 h 
 
 
 
 
 
 
 
8 h 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 125 of 128  
 
 
 
Study Day 
Time point 
Plasma PK 
Safety Labs and 
Urinalysis 
Holter Extractions 
Vital Signsa 
Orthostatic Vital 
Signs 
Single 
12-lead 
ECGs 
Triplicate 
12-lead 
ECGs 
9 h 
 
 
 
 
 
 
 
10 h 
 
 
 
X 
 
 
 
11 h 
 
 
 
 
 
 
 
12 h 
X 
 
 
X 
 
 
X 
3 
-1.5 h 
 
 
X 
 
 
X 
 
-1 h 
 
 
X 
 
 
X 
 
Pre-dose (-0.5 h)c 
X 
X (Day 1, 48 h) 
X (Day 1, 48 h) 
X 
X 
X 
 
0 h 
 
 
 
 
 
 
 
0.5 h 
X 
 
X 
X 
 
X 
 
1 h 
X 
 
X 
X 
 
X 
 
2 h 
X 
 
X 
X 
X 
X 
 
3 h 
X 
 
X 
X 
 
X 
 
4 h 
X 
 
X 
X 
X 
X 
 
5 h 
X 
 
 
 
 
 
 
6 h 
X 
 
X 
X 
X 
X 
 
7 h 
 
 
 
 
 
 
 
8 h 
X 
 
X 
X 
 
X 
 
9 h 
 
 
 
 
 
 
 
10 h 
 
 
X 
X 
 
 
 
11 h 
 
 
X 
 
 
 
 
12 h 
X 
 
X 
X 
X 
X 
 
4 
24 h 
X 
 
X 
X 
X 
X 
 
36 h 
X 
 
 
X 
 
 
X 
5 
48 h 
X 
X 
 
X 
 
 
X 
6 
72 h 
X 
 
 
X 
 
 
X 
7 
96 h 
X 
X 
 
X 
 
 
X 
9 
144 h 
X 
X 
 
X 
X 
 
X 
a Blood pressure, heart rate and respiratory rate at all time points. 
b 24 h post-dose Day 1 sample will be taken pre-dose on Day 2  
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 126 of 128  
 
 
 
c 24 h post-dose Day 2 sample will be taken pre-dose on Day 3  
Allowable windows for PK blood sampling, vital signs assessments and ECGs can be found in: Sections 13.1, 14.6, 14.7 of the study 
protocol. 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 127 of 128  
 
 
 
Appendix 7 
Example Taste/Palatability Questionnaire  
An example of the taste/palatability questionnaire can be found on the next page. 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Sponsor/Quotient Sciences Confidential 
 
Reporting and Analysis Plan MMV_MMV367_21_01(QSC207031) Final v2.0 
15 Dec 2022 
Page 128 of 128  
 
 
 
Study Part: 
 
 
Test Product: 
 
 
Participant Number: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Initials: 
 
 
 
Start time: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(to be completed within 10 minutes of tasting) 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
Question 1 
All aspects considered (smell, sweetness, bitterness, flavour, mouthfeel/texture, grittiness, and aftertaste), how would you rate your overall liking of this 
product:  
NOTE: Tick 1 box below in blue or black pen 
Question 2 
We want to know how much you like certain aspects of the product: smell, sweetness, bitterness, flavour, mouthfeel/texture, grittiness, and aftertaste. 
NOTE: Tick 1 box in the row for each aspect 
 
Dislike 
extremely 
Dislike very 
much 
Dislike 
moderately 
Dislike 
slightly 
Neither like 
nor dislike Like slightly 
Like 
moderately 
Like very 
much 
Like 
extremely 
N/A 
Smell 
 
 
 
 
 
 
 
 
 
 
Sweetness 
 
 
 
 
 
 
 
 
 
 
Bitterness 
 
 
 
 
 
 
 
 
 
 
Flavour 
 
 
 
 
 
 
 
 
 
 
Mouthfeel/texture 
 
 
 
 
 
 
 
 
 
 
Grittiness 
 
 
 
 
 
 
 
 
 
 
Aftertaste 
 
 
 
 
 
 
 
 
 
 
Entered 
into 
eCRF 
by 
(initials): 
 
Date: 
 
QC 
checked 
by 
(initials): 
 
Date: 
 
 
Dislike 
extremely 
Dislike very 
much 
Dislike 
moderately 
Dislike 
slightly 
Neither like 
nor dislike 
Like slightly 
Like 
moderately 
Like very 
much 
Like 
extremely 
 
 
 
 
 
 
 
 
 
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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Document Approvals
Approved Date: 19 Dec 2022
Document Author(s):  Claire Wilson 
Approval Task
Verdict:  Approve
Claire Wilson, Senior Statistician
(Claire.Wilson@quotientsciences.com)
Functional / Technical Approval
19-Dec-2022 12:57:52 GMT+0000
Approval Task
Verdict:  Approve
Ewan Thomson, Manager, Statistical Programming
(Ewan.Thomson@quotientsciences.com)
Functional / Technical Approval
19-Dec-2022 13:36:26 GMT+0000
Approval Task
Verdict:  Approve
Nand Singh, Medical Director
(Nand.Singh@quotientsciences.com)
Functional / Technical Approval
19-Dec-2022 13:41:03 GMT+0000
Approval Task
Verdict:  Approve
Gemma Bell, Senior Medical Writer
(gemma.bell@quotientsciences.com)
Functional / Technical Approval
19-Dec-2022 15:45:47 GMT+0000
Approval Task
Verdict:  Approve
Tom Dove, Pharmacokineticist
(Tom.Dove@quotientsciences.com)
Functional / Technical Approval
19-Dec-2022 16:05:15 GMT+0000
Number: DOC-101489               Version: 2.0               Status: Approved    Approved Date: 19 Dec 2022
QSC207031(MMV_MMV367_21_01) - Reporting and Analysis Plan
This copy was downloaded by Claire Wilson on 19 Dec 2022 at 16:25 GMT+00:00
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