A Phase 1, Single-site, Open-label Study to Determine the Safety and Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy Volunteers
Phase: PHASE1
Conditions: COVID-19
Sponsor: Lumen Bioscience, Inc.

CLINICAL STUDY PROTOCOL 
Document Date: Version 1.0, 25 May 2023 
NCT #: NCT06030414 
 

Lumen Bioscience, Inc. 
Protocol No.: COV01 
 
 
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Page 1 of 80 
 
TITLE PAGE  
CLINICAL STUDY PROTOCOL 
 
Protocol Number 
COV01 
EudraCT Number 
N/A 
Universal Trial Number 
N/A 
IND Number 
Not yet assigned 
Study Title 
A Phase 1, Single-site, Open-label Study to Determine 
the Safety and Tolerability of Single and Multiple Doses 
of Intranasally Administered LMN-301 in Healthy 
Volunteers 
Overall Study Phase 
Phase I 
Investigational Product 
LMN-301 
Route of Administration 
Intranasal (IN) 
Global Sponsor Representative 
Lumen Bioscience, Inc. 
1441 North 34th Street 
Suite 300 
Seattle, WA 98103 
USA 
Tel: +1-206-899-1904 
 
 
Local Sponsor (Australia) 
Avance Clinical  
Level 1, 2 Ann Nelson Drive,  
Thebarton, South Australia 5031 
Tel: +61 8 8249 4788 
Version 
v1.0, 25 May 2023 
 
CONFIDENTIALITY STATEMENT 
Information contained in this study protocol is confidential and should not be disclosed, 
without written authorisation from Lumen Bioscience, Inc. 
 
 
 

Lumen Bioscience, Inc. 
Protocol No.: COV01 
 
 
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Page 2 of 80 
 
SPONSOR SIGNATURE PAGE 
Study Title: A Phase 1, Single-Site, Open-Label Study to Determine the Safety and 
Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy 
Volunteers 
 
 
 
 
 
 
 
 
 
Signature of Sponsor Representative  
 
Date 
Carl Mason, MD 
Printed Name of Sponsor Representative  
Vice President, Clinical 
Sponsor Representative Role/Designation 
By my signature, I confirm that I have reviewed this protocol and find its content to be 
acceptable. 
 
 
 

Lumen Bioscience, Inc. 
Protocol No.: COV01 
 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE 
PAGE 
Study Title: A Phase 1, Single-Site, Open-Label Study to Determine the Safety and 
Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy 
Volunteers 
 
 
 
 
 
 
 
 
Signature of Site Principal Investigator  
 
Date 
 
Printed Name of Site Principal Investigator 
Investigator Address: 
 
Investigator Telephone: 
 
 
Institution Name 
Institution Address: 
 
Institution Telephone: 
By my signature, I confirm that I have read the protocol, I understand it, and I agree to 
personally conduct and supervise the conduct of this study in compliance with the protocol, 
Human Research Ethics Committee (HREC) procedures, instructions from Lumen 
Bioscience, Inc, the Declaration of Helsinki, International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice 
Guidelines, and local regulations governing the conduct of clinical studies. 
CMAX Clinical 
Research Pty Ltd
Ground Floor, 21-24 
North Terrace 
Adelaide SA 5000
Australia
+61 8 7088 7900 
25-May-2023 | 14:48 ACST
Ground Floor, 21-24 
North Terrace 
Adelaide SA 5000
Australia
+61 8 7088 7900 
Xiu Qin Lim

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Protocol No.: COV01 
 
 
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1 
PROTOCOL SYNOPSIS 
Study Title 
A Phase 1, Single-Site, Open-Label Study to Determine the Safety and 
Tolerability of Single and Multiple Doses of Intranasally Administered LMN-
301 in Healthy Volunteers. 
Protocol Number 
COV01 
Phase 
I 
Number of Clinical 
Sites 
1 
Investigational 
Product  
LMN-301 
Mode of 
Administration 
Intranasal (IN) 
Dose Range 
• 
Part A: single fixed dose of 50 mg IN (25 mg in each nostril) using 
the Unidose (UDS) Powder Nasal Spray System device (Aptar) on 
Day 1 
• 
Part B: multiple fixed doses of 50 mg (25 mg in each nostril) using 
the Unidose (UDS) Powder Nasal Spray System device (Aptar) 
Number of Doses 
• 
Part A: Single dose on Day 1 
• 
Part B:  
o Group 1: once every third day for 12 days (4 doses total), 
o Group 2: once every other day for 12 days (6 doses total)  
o Group 3: once every day for 12 days (12 doses total) 
Study Population 
Healthy adult volunteers aged 18-65 years, with BMI between 18.0 and 30.0 
kg/m2, and maximum body weight of 120 kg. 
Additional selection criteria apply as described in the study inclusion and 
exclusion criteria (refer Protocol Section 7). 
Study Rationale 
SARS-CoV-2 infection is initiated by binding of the receptor binding domain 
(RBD) on the virus spike protein to the angiotensin-converting enzyme 2 
(ACE2) receptor on the target cell membrane. The nasal cavity contains a high 
SARS-CoV-2 viral load and the intranasal epithelium is considered an 
important entry portal for the virus. Anti-viral drugs may complement the role 
of vaccines in the prevention of SARS-CoV-2 infection, by directly delivering 
biologic neutralization agents that are immediately effective upon 
administration and can act independently of the host’s immune system.  
Spirulina (Arthrospira platensis) is a type of blue-green algae capable of high 
expression levels of therapeutic proteins. Spirulina extract powders containing 
pathogen neutralizing proteins may serve as an effective antiviral drug. Lumen 
Bioscience has developed methods to genetically engineer spirulina for large-
scale biologics manufacturing, and has developed processes to generate a 
shelf-stable dried spirulina extract containing bioactive protein. Lumen 

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proposes to intranasally deliver anti-SARS-CoV-2 viral-binding proteins to 
the upper airway mucosa using a dry powder inhaler. The product objective is 
to prevent disease in uninfected individuals and potentially block transmission 
from infected individuals to others.  
 
Study Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary 
To determine the safety and 
tolerability of single and 
multiple doses of 
intranasally delivered LMN-
301 
• 
Safety and tolerability of single and 
multiple doses of intranasally administered 
LMN-301 as measured by:  
o The occurrence of solicited AEs for 28 
days after the first dose of LMN-301 
o The occurrence of unsolicited 
AE/SAEs for up to 28 days after the 
first dose of LMN-301  
o Discontinuation 
o Changes from baseline in vital signs, 
safety laboratory parameters, ECG 
parameters and nasal symptoms using 
the Sino-nasal outcome test   
Secondary 
To determine the persistence 
profile of LMN-301 in the 
nasal mucosa following 
single and multiple doses 
• 
Detect the presence of LMN-301 in nasal 
mucosal lining fluid samples collected from 
study participants 
Exploratory 
To detect the presence of 
LMN-301 and anti-drug 
antibodies in serum 
• 
Detection of LMN-301 virus-binding 
proteins and, if virus-binding proteins are 
detected, anti-virus binding protein IgG in 
serum samples 
 
Overall Study 
Design 
This is a Phase I, open-label, single site study of LMN-301 administered 
intranasally as single or multiple doses in healthy volunteers. 
This study will be conducted in two parts. 
Part A (Sentinel, Single-Dose Cohort) 
On Day 1, 5 participants will be administered a single dose of LMN-301 IN to 
each nostril at a fixed dose of 50 mg (25 mg in each nostril) using the Unidose 
(UDS) Powder Nasal Spray System device (Aptar). Participants will be 
observed as in-patients for at least 24 hours, and then followed on an 
outpatient basis for 14 days. Protocol-specified evaluations and procedures 
will be performed on Days 1-2 and then weekly or bi-weekly. 
The safety and tolerability data collected from the sentinel cohort participants 
will be reviewed by the principal investigator (PI), the independent medical 
monitor, and the sponsor medical monitor, either via email or meeting if 
required. The PI will decide whether to move forward with the multiple-dose 

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cohorts (Part B).  
Part B (Multi-Dose cohort) 
Up to 30 participants will be sequentially assigned to one of three dosing 
groups (10 participants per group) starting with Group 1. Participants will be 
administered LMN-301 IN to each nostril at a fixed dose of 50 mg (25 mg in 
each nostril) every third day for 12 days (Group 1), every other day for 12 
days (Group 2) or every day for 12 days (Group 3). All study participants will 
be observed in the clinic for 4 hours after the first dose. 
Throughout the treatment period, participants will be monitored for the 
occurrence of any adverse events (AEs) and serious adverse events (SAEs). 
Vital signs, physical exams and safety/laboratory testing will be performed on 
Days 1, 3 or 4, 7, 10 or 11, and 14. Participants will use a diary (paper or 
electronic) to record concomitant medication usage and any symptoms from 
the first dose through 28 days after the first dose. Macroscopic nasal 
examination will be performed by conventional anterior rhinoscopy and nasal 
symptoms and social/emotional consequences will be assessed using the Sino-
nasal outcome test (SNOT-22).  
Serum will be collected on Days 1 (baseline before dosing and 2 hours after 
dosing), 3 or 4, 7 and 14 for analysis to detect systemic absorption of virus-
binding proteins and anti-drug antibodies (ADA).  
Nasal mucosal lining fluid (MLF) samples will be collected using Synthetic 
Absorptive Matrix (SAM) strips (Nasosorption™ FX∙I, Hunt Developments 
(UK) Ltd, United Kingdom) from all participants on Day 1 (baseline before 
dosing and 2 hours after dosing), and on Days 3 or 4, 7 and 14. Nasal MLF 
samples will be sent to Lumen Bioscience (Seattle, WA, USA) for analysis. 
Safety Review  
There is no safety review committee for this study, however safety and 
tolerability data collected from the sentinel cohort participants will be 
reviewed by the principal investigator, the medical monitor, and the sponsor 
medical monitor, to decide whether to move forward with the multiple-dose 
cohorts (Part B). The discussion will include review of the study and 
individual stopping rules. The PI will make the final decision regarding 
moving forward with the multiple dose cohorts, taking into account 
recommendations from the medical monitor and the sponsor medical monitor. 
If stopping criteria are met in Part B, dosing will stop and the principal 
investigator, the medical monitor, and the sponsor medical monitor will review 
safety and tolerability data and decide whether to proceed with dosing. 
Number of 
Participants 
A total of 35 participants are planned to be enrolled as follows: 
• 
Part A: Up to 5 participants  
• 
Part B: Up to 30 participants across 3 groups (10 participants per group) 
Study Duration 
The expected duration of participant engagement is as follows: 
• 
Part A: Up to 42 days, inclusive of 28 day screening window. 
• 
Part B: Up to 56 days, inclusive of 28 day screening window. 
Study Procedures 
Baseline, Safety and Tolerability Assessments 
• 
Demographics (age, race, sex, and ethnicity) 
• 
Medical history 

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• 
Prior and concomitant medication assessments 
• 
Physical examination  
• 
Nasal examination 
• 
Height, weight, and calculation of Body Mass Index (BMI) 
• 
Vital signs (systolic and diastolic blood pressure, pulse rate, oral 
temperature, respiration rate) 
• 
ECG 
• 
Urinalysis 
• 
COVID-19 rapid antigen testing (prior to IP administration) 
• 
Serum (Screening) and urine (prior to first study drug administration) 
pregnancy test (women of child-bearing potential only) 
• 
FSH levels (post-menopausal women only) 
• 
Viral serology (HIV antibody, HBsAg and HCV antibody) 
• 
Urine toxicology screen for drugs of abuse 
• 
Solicited adverse events (stuffy nose, runny nose, sneezing, nasal 
irritation, nasal tenderness/pain, loss of smell, sore/scratchy throat, 
cough) 
• 
Unsolicited adverse events 
• 
Sino-nasal outcome test (SNOT-22) 
• 
Clinical laboratory safety assessments (hematology, serum chemistry 
and coagulation)  
Pharmacokinetic Assessments 
• 
Whole blood (serum) 
• 
Nasal mucosal lining fluid (MLF) 
Immunogenicity Assessments 
• 
Whole blood (serum) anti-drug antibodies 
Statistical Analyses Detailed methodology for summaries and statistical analyses of the data 
collected will be documented in a separate Statistical Analysis Plan (SAP). 
In general, summaries will be presented separately for Parts A and B, with 
summaries presented by treatment group and overall for Part B. 
For descriptive statistics, continuous data will be summarised by treatment 
arm and time point using the number of observations, arithmetic mean, 
standard deviation (SD), median, minimum and maximum. Discrete data will 
be summarised using counts and percentages. 
All available data will be included in data listings. Data tabulations will be 
performed for specific analysis populations. 
Demographic data (including gender, age, race, ethnicity, height, weight, and 
BMI) will be summarised using descriptive statistics. Medical history will be 
coded using the latest version of the Medical Dictionary for Regulatory 
Activities (MedDRA) 
All AEs will be coded using the latest version of MedDRA by system organ 
class and preferred term, classified from verbatim terms. Observed values and 
changes from baseline for vital signs, clinical laboratory parameters and ECG 
parameters will be summarised at each scheduled timepoint using descriptive 
statistics. Physical examinations and nasal examination findings will be listed; 

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any clinically significant post-dose findings will be recorded as AEs.  
Individual participant LMN-301 concentrations in plasma and nasal mucosal 
lining fluid will be listed and summarised using descriptive statistics (n, mean, 
standard deviation, coefficient of variation [%CV], minimum, maximum, 
median, geometric mean and geometric coefficient of variation). Due to the 
sparseness of the PK sampling scheme, no PK parameters will be determined.  
Serum anti-LMN-301 antibody (possibly binary yes/no, titer, neutralizing) on 
Day 0 (predose), Day 1 (post dose), Day 3 or 4 (predose), Day 7 (predose) and 
Day 14 will be reported for each subject and presented tabular and/or graphical 
form.   
Changes from baseline in individual total SNOT-22 scores will be calculated 
as the post-baseline value minus the baseline value and summarised using 
descriptive statistics. 
 
 
 

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2 
TABLE OF CONTENTS 
 
TITLE PAGE ........................................................................................................................... 1 
SPONSOR SIGNATURE PAGE ............................................................................................ 2 
SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE .............................................. 3 
1 PROTOCOL SYNOPSIS ...................................................................................................... 4 
2 TABLE OF CONTENTS ...................................................................................................... 9 
2.1 
List of Tables ............................................................................................................. 13 
2.2 
List of Figures ............................................................................................................ 13 
3 LIST OF ABBREVIATIONS AND TERMS ..................................................................... 14 
4 INTRODUCTION ............................................................................................................... 16 
4.1 
Background Information and Rationale ..................................................................... 16 
4.2 
Selection of Dose ....................................................................................................... 18 
4.3 
Risk/Benefit Assessment ........................................................................................... 19 
5 STUDY OBJECTIVES AND ENDPOINTS ...................................................................... 20 
6 STUDY DESIGN ................................................................................................................ 21 
6.1 
Overall Design Type and Description ....................................................................... 21 
6.2 
Part A (Sentinel Cohort) ............................................................................................ 21 
6.3 
Part B (Multiple Dose) ............................................................................................... 21 
6.4 
Safety Review ............................................................................................................ 22 
6.4.1 
Safety Review Committee ....................................................................................................... 22 
6.4.2 
Dose Stopping Rules ................................................................................................................ 22 
6.5 
Participant Withdrawal Criteria ................................................................................. 23 
6.6 
Suspension or Termination of the Study at the Investigational Site .......................... 23 
6.7 
Treatment Allocation ................................................................................................. 24 
7 PARTICIPANT SELECTION ............................................................................................ 24 
7.1 
Inclusion Criteria ....................................................................................................... 24 
7.2 
Exclusion Criteria ...................................................................................................... 25 
7.3 
Participant Replacement ............................................................................................ 26 
8 INVESTIGATIONAL PRODUCT ..................................................................................... 26 
8.1 
Description of Investigational Product ...................................................................... 26 
8.2 
Supply, Packaging and Labelling .............................................................................. 26 
8.3 
Storage ....................................................................................................................... 27 
8.4 
Investigational Product Dispensing ........................................................................... 27 
8.5 
Administration of Investigational Product ................................................................. 27 
8.6 
Accountability of Investigational Product Supplies .................................................. 29 
9 PRIOR/CONCOMITANT MEDICATIONS AND OTHER RESTRICTIONS ................. 30 

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9.1 
Prior and Concomitant Medications .......................................................................... 30 
9.2 
Tobacco and Alcohol ................................................................................................. 30 
9.3 
Contraception ............................................................................................................. 30 
9.4 
Fasting ........................................................................................................................ 31 
9.5 
Blood Donation .......................................................................................................... 31 
10 STUDY SCHEDULE .......................................................................................................... 32 
10.1 Screening ................................................................................................................... 32 
10.2 Part A Sentinel Cohort (open-label, one fixed dose) ................................................. 32 
10.2.1 
Day 1 Inpatient ......................................................................................................................... 32 
10.2.2 
Day 2 Inpatient ......................................................................................................................... 33 
10.2.3 
Days 3-7 ................................................................................................................................... 33 
10.2.4 
Day 8 Outpatient Visit ............................................................................................................. 33 
10.2.5 
Day 14 Outpatient Visit (End of Study) ................................................................................... 34 
10.3 Part B Multi-Dose Cohort (Multi-dose, Open-label) ................................................. 34 
10.3.1 
Day 1 ........................................................................................................................................ 34 
10.3.2 
Day 2-12 Treatment Phase and Clinic Visits ........................................................................... 35 
10.3.3 
Day 14 Follow-up visit ............................................................................................................ 36 
10.3.4 
Days 15-17 ............................................................................................................................... 37 
10.3.5 
Day 28 End of Study Visit ....................................................................................................... 37 
11 STUDY PROCEDURES .................................................................................................... 37 
11.1 Informed Consent ...................................................................................................... 37 
11.2 Demographics ............................................................................................................ 38 
11.3 Medical and Surgical History .................................................................................... 38 
11.4 Prior and Concomitant Medications and Therapies ................................................... 38 
11.5 Height and Weight ..................................................................................................... 38 
11.6 COVID-19 Rapid Antigen Test ................................................................................. 38 
11.7 Follicle-Stimulating Hormone ................................................................................... 38 
11.8 Pregnancy Test ........................................................................................................... 38 
11.9 Serology ..................................................................................................................... 39 
11.10 Clinical Laboratory Assessments............................................................................... 39 
11.11 Physical Examination ................................................................................................ 39 
11.12 Nasal Examination ..................................................................................................... 39 
11.13 Vital Signs.................................................................................................................. 40 
11.14 Electrocardiogram ...................................................................................................... 40 
11.15 Nasal Symptoms by Sino-Nasal Outcome Test ......................................................... 41 
11.16 Study Diary ................................................................................................................ 41 
11.17 Pharmacokinetic Assessments ................................................................................... 41 

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11.17.1 
Blood ........................................................................................................................................ 41 
11.17.2 
Nasal Secretions ....................................................................................................................... 41 
11.18 Immunogenicity Assessments.................................................................................... 42 
11.19 Blood Sample Volumes ............................................................................................. 42 
12 ASSESSMENT AND MANAGEMENT OF ADVERSE EVENTS .................................. 44 
12.1 Adverse Event Definitions ......................................................................................... 44 
12.2 Evaluating Adverse Events and Serious Adverse Events .......................................... 45 
12.2.1 
Assessment of Severity ............................................................................................................ 45 
12.2.2 
Assessment of Causality .......................................................................................................... 45 
12.3 Procedures and Time Period for Detecting Adverse Events...................................... 46 
12.4 Recording of Adverse Events and Serious Adverse Events ...................................... 47 
12.5 Reporting of Serious Adverse Events and Suspected Unexpected Serious Adverse 
Reactions .................................................................................................................... 47 
12.6 Follow-up of Adverse Events and Serious Adverse Events ...................................... 48 
12.7 Exposure In Utero Management and Reporting ........................................................ 49 
13 STATISTICS AND DATA ANALYSIS ............................................................................ 50 
13.1 Sample Size Considerations....................................................................................... 50 
13.2 Analysis Populations.................................................................................................. 50 
13.3 Disposition ................................................................................................................. 50 
13.4 Demographic and Baseline Data................................................................................ 51 
13.5 Prior and Concomitant Medication Data ................................................................... 51 
13.6 Treatment Compliance and Exposure Data ............................................................... 51 
13.7 Safety and Tolerability Data ...................................................................................... 51 
13.7.1 
Adverse Event Data ................................................................................................................. 51 
13.7.2 
Vital Signs................................................................................................................................ 52 
13.7.3 
Nasal Examinations ................................................................................................................. 52 
13.7.4 
Physical Examination Data ...................................................................................................... 52 
13.7.5 
Clinical Laboratory Safety Data .............................................................................................. 52 
13.7.6 
Electrocardiogram .................................................................................................................... 52 
13.7.7 
Nasal Symptoms Sino-Nasal Outcome Test ............................................................................ 52 
13.8 Pharmacokinetic Data ................................................................................................ 53 
13.9 Immunogenicity Data ................................................................................................ 53 
13.10 Interim Analysis ......................................................................................................... 53 
14 DATA HANDLING AND RECORD KEEPING ............................................................... 53 
14.1 Privacy of Personal Data............................................................................................ 53 
14.2 Screening/Enrolment Logs and Privacy .................................................................... 54 
14.3 Source Documentation ............................................................................................... 54 

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14.4 Electronic Case Report Form ..................................................................................... 54 
14.5 Recordkeeping and Retention of Records ................................................................. 55 
15 ETHICS AND REGULATORY COMPLIANCE .............................................................. 57 
15.1 Investigator Responsibilities ...................................................................................... 57 
15.2 Regulatory Notification ............................................................................................. 57 
15.3 Ethical Considerations ............................................................................................... 57 
15.4 Informed Consent ...................................................................................................... 58 
15.5 Emergency Contact with Principal Investigator ........................................................ 58 
15.6 Clinical Laboratory Certification and Reference Ranges .......................................... 58 
15.7 Study Completion/Site Closure ................................................................................. 58 
15.8 End of Study and Regulatory Notification ................................................................ 59 
16 QUALITY CONTROL AND ASSURANCE ..................................................................... 60 
16.1 Study Monitoring ....................................................................................................... 60 
16.2 Quality Assurance and Quality Control ..................................................................... 61 
16.3 Data Quality Control .................................................................................................. 61 
17 FINANCING AND INSURANCE ..................................................................................... 62 
18 PROTOCOL GUIDELINES ............................................................................................... 63 
18.1 Protocol Deviations.................................................................................................... 63 
18.2 Protocol Waivers........................................................................................................ 63 
18.3 Protocol Amendments................................................................................................ 63 
19 INTELLECUTAL PROPERTY, CONFIDENTIALITY AND PUBLICATIONS ............ 64 
19.1 Ownership .................................................................................................................. 64 
19.2 Confidentiality ........................................................................................................... 64 
19.3 Publication Policy ...................................................................................................... 64 
20 REFERENCES .................................................................................................................... 65 
21 APPENDICES ..................................................................................................................... 69 
21.1 Appendix 1. Schedule of Assessments ...................................................................... 70 
21.1.1 
Part A (Single Dose) ................................................................................................................ 70 
21.1.2 
Part B (Multiple Dose) ............................................................................................................. 73 
21.2 Appendix 2. Pharmacokinetic and Immunogenicity Sampling Schedule.................. 77 
21.2.1 
Part A (Single Dose) ................................................................................................................ 77 
21.2.2 
Part B (Multiple Dose) ............................................................................................................. 77 
21.3 Appendix 3  Vital Signs Assessment Schedule ......................................................... 78 
21.3.1 
Part A (Single Dose) ................................................................................................................ 78 
21.3.2 
Part B (Multiple Dose) ............................................................................................................. 78 
21.4 Appendix 4. Highly Effective Forms of Birth Control .............................................. 79 
21.5 Appendix 5: Clinical Laboratory Assessments .......................................................... 80 

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2.1 
List of Tables 
Table 5-A  
LMN-301 COV01 Study Objectives and Endpoints ....................................... 20 
Table 8-A  
LMN-301 Dosing of Study Participants in Study Parts A and B .................... 28 
Table 11-A  
Approximate Blood Sample Volumes Collected Per Participant (Part 1, Single 
Dose) - Individual .................................................................................................... 42 
Table 11-B  
Approximate Blood Sample Volumes Collected Per Participant (Part 2, 
Multiple Dose) ......................................................................................................... 43 
Table 12-A  
NCI-CTCAE 5-point Scale for Grading the Intensity of Each AE and SAE .. 45 
Table 12-B  
Categories for Assessing Relationship of an Adverse Event to Study Drug ... 46 
Table 12-C  
Contact Details for Transmission of Serious Adverse Event Reporting Forms .. 
 
 .......................................................................................................................... 47 
Table 21-A  
Schedule of Assessments for Part A Sentinel Cohort (Open-label, single dose) . 
 
 .......................................................................................................................... 70 
Table 21-B  
Schedule of Assessments for Part B Multi-Dose Cohort (Open-label, multi-
dose) ........................................................................................................................ 73 
Table 21-C  
Pharmacokinetic and Immunogenicity Sampling Schedule (Part A, Single 
Dose) ....................................................................................................................... 77 
Table 21-D  
Pharmacokinetic and Immunogenicity Sampling Schedule (Part B Multiple 
Dose) ....................................................................................................................... 77 
Table 21-E  
Vital Signs Assessment Schedule (Part A, Single Dose) ................................. 78 
Table 21-F 
Vital Signs Assessment Schedule (Part B, Multiple Dose) ............................. 78 
2.2 
List of Figures 
Figure 5-A 
Product Objective: Prevent disease in uninfected individuals and potentially 
block transmission from infected individuals to others ........................................... 17 
Figure 5-B 
Mean clinical sign for vehicle and dual treatment groups ............................... 18 
Figure 9-A  
Unidose Nasal Device ...................................................................................... 28 
 
 
 

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3 
LIST OF ABBREVIATIONS AND TERMS 
ACE2 
Angiotensin-Converting Enzyme 2 
ADA 
Anti-Drug Antibodies  
AE 
Adverse Event 
ATC 
Anatomical Therapeutic Chemical Classification 
CFR 
Code of Federal Regulations 
Covid-19 
Coronavirus Disease 2019 
CRA 
Clinical Research Associate 
CRF 
Case Report Form  
CS 
Clinically Significant 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
GCP 
Good Clinical Practice 
cGMP 
Current Good Manufacturing Practices 
FDA 
Food and Drug Administration  
FSH 
Follicle-Stimulating Hormone  
GRAS 
Generally Regarded as Safe 
HREC 
Human research ethics committee 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IgG 
Immunoglobulin G 
INR 
International Normalised Ratio 
IP 
Investigational Product 
IUD 
Intrauterine device 
MedDRA 
Medical Dictionary for Regulatory Activities 
MLF 
Mucosal Lining Fluid 
NCS 
Not Clinically Significant 
OTC 
Over the Counter 
PI 
Principal Investigator 
PK 
Pharmacokinetic  
PLOS 
Public Library of Science 
PT 
Preferred Term 
PT/PTT 
Prothrombin Time/ Partial Thromboplastin Time 
QTcF 
QT interval corrected by Fridericia formula 

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RBD 
Receptor Binding Domain 
RR 
Respiratory Rate 
SAE 
Serious Adverse Event 
SAM 
Synthetic Absorptive Matrix 
SAP 
Statistical Analysis Plan 
SARS 
Severe Acute Respiratory Syndrome 
SARS-CoV-2 
SARS-associated coronavirus 2, the virus the causes Covid-19 
SD 
Standard Deviation 
SoA 
Schedule of Assessments 
SOC 
System Organ Class 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
Treatment-Emergent Adverse Event 
UDS 
Aptar Unidose Powder Nasal Spray System Device  
US FDA 
United States Food and Drug Administration 
VHH 
Binding Domain Fragment of a Single-Domain Camelid 
Antibody 
 
 

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4 
INTRODUCTION 
4.1 
Background Information and Rationale 
SARS-CoV-2 infection is initiated by binding of the receptor binding domain (RBD) on the 
virus spike protein to the angiotensin-converting enzyme 2 (ACE2) receptor on the target cell 
membrane (Jackson et al. 2022). The nasal cavity contains a high SARS-CoV-2 viral load 
and the intranasal epithelium is considered an important entry portal for the virus (Higgins et 
al. 2020; Sungnak et al. 2020). 
Antiviral drugs complement the role played by vaccines in public health. Rather than eliciting 
a neutralizing response from the host immune system, antiviral drugs directly deliver biologic 
neutralization agents that are immediately effective upon administration and can act 
independently of the host’s immune system. Despite the advantages of antiviral drugs, the 
high cost and limited scalability of biologics manufacturing has prevented widespread 
adoption. 
Spirulina (Arthrospira platensis) is a type of blue-green algae. It is capable of high expression 
levels of therapeutic proteins and requires only water, light, CO2 and mineral salts for its 
production environment. Because the manufacturing pipeline is comprised solely of growing 
and drying spirulina biomass, it reduces or eliminates the technical challenges and expenses 
associated with downstream drug processing. This results in a cost-effective system that 
finally makes it feasible to deliver daily doses of protein therapeutics at mass scale. 
Lumen Bioscience developed the methods to genetically engineer spirulina for large-scale 
biologics manufacturing. Initial therapeutic spirulina products were formulated for oral 
administration, and in vivo efficacy has been demonstrated in multiple studies (Jester, et al. 
2022; Zhao, et al. 2022). Lumen Bioscience has expanded its platform capabilities by 
developing manufacturing-scale compatible processes to generate a shelf-stable dried 
spirulina extract containing bioactive protein. The spirulina biomass is inert (nonviable) 
following the extraction process.  Based on recent preclinical data from hamster SARS-CoV-
2 challenge studies, we expect that spirulina extract powders containing pathogen 
neutralizing proteins can serve as an effective antiviral drug. Lumen proposes to intranasally 
deliver anti-SARS-CoV-2 viral-binding proteins to the upper airway mucosa using a dry 
powder inhaler. The product objective is to prevent disease in uninfected individuals and 
potentially block transmission from infected individuals to others (Figure 4-A). 
 
 
 
 
 
 

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Figure 4-A 
Product Objective: Prevent disease in uninfected individuals and 
potentially block transmission from infected individuals to others 
 
 
The investigational product, LMN-301, consists of intranasally delivered soluble extract of 
spirulina (Arthrospira platensis) grown from two separate strains, each of which has been 
engineered to express intracellularly an antibody-like fusion protein that binds and inhibits 
SARS-CoV-2. Spirulina was selected as the expression host because of its favourable safety 
and manufacturing characteristics. The engineered virus-binding proteins are derived in part 
from the antigen-binding domains of camelid single-domain antibodies (also known as VHHs 
or nanobodies). LMN-301 will be delivered as a dry powder using a single Unidose (UDS) 
Power Nasal Spray System device (Aptar, Crystal Lake, IL, USA). 
Two in vivo hamster SARS-CoV-2 challenge studies were performed using a single VHH 
(SP1844) contained in the LMN-301 intranasal product to demonstrate safety and efficacy. 
Due to the difficulty of dry powder delivery in a small rodent model, the dry powder was 
delivered as a reconstituted slurry.  
In the first study, a single pre- or post- treatment with the spirulina product administered 
intranasally—either before or after SARS CoV-2 exposure— improved clinical outcomes 
significantly. The dual, two-dose treatment had an even greater effect, appearing to prevent 
disease completely (Figure 4-B). The dose size was comparable to the dose planned for this 
Phase 1 trial and was well tolerated in this hamster challenge model. Clinical observations 
were recorded twice daily throughout the study. No adverse clinical observations were 
reported that were deemed attributable to vehicle or test item administration. 
 
 
 
 

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 Figure 4-B 
Mean clinical sign for vehicle and dual treatment groups  
 
Dual=pre- and post-exposure administration 
The second smaller hamster challenge study in the US, had results consistent with the first 
study. LMN-301 was well tolerated and showed no adverse effects in this second hamster 
challenge study. 
Further details of these studies are provided in the Investigator Brochure. 
4.2 
Selection of Dose 
The amount of powder to be administered is the maximum tolerated amount according to the 
device manufacturer Aptar. 
The dose of LMN-301 selected for use in this clinical study (50 mg total per dose, delivered 
IN as 25 mg to each nostril) is comparable to the doses that were well tolerated in the hamster 
challenge studies. In the hamster study, 5 mg dry weight of extract was administered per nare, 
with each animal receiving 10 mg total dry weight. The estimated nasal surface area of a 
hamster is 1000 mm2, compared with 18,000 mm2 for humans, resulting in a scaling factor 
of 18x. A direct scaling of the well-tolerated hamster dose would therefore be 90 mg per 
nostril or 180 mg total per patient. This would significantly exceed the manufacturer’s 
recommendation for the device. By administering less than 1/3 of the scaled equivalent dose 
already tested in hamsters, tolerability concerns are not expected. 
Both therapeutic proteins in LMN-301 have low potential for systemic exposure and 
immunogenicity because of:  
• their large size, which prevents intact systemic absorption 
• the route of administration (intranasal)   
• the lack of glycosylation and human Fc domains, which are required for active 
antibody transport mechanisms.  
For further information, please refer to the Investigator Brochure. 

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4.3 
Risk/Benefit Assessment 
The potential risks are those associated with phlebotomy and intranasal administration of 
LMN-301. 
Anticipated reactions: Volunteers may experience localized reactions such as sneezing, nasal 
discharge, nasal tenderness or pain, or nasal irritation post intranasal administration of 
LMN-301. 
Intranasally administered recombinant protein therapeutics have been evaluated in humans 
since the dawn of the modern biotechnology era. Starting in 1982 with recombinant 
interferon therapy (Scott et al., 1982), a wide range of therapeutic proteins have been safely 
tested in humans. As might be expected given what is known about the barrier function of 
mucosal tissues, across scores of independent clinical trials spanning four decades, none of 
these report significant adverse events plausibly related to the intranasally administered 
protein therapeutic (see, e.g., Scott et al., 1982; Higgins et al., 1983; Hayden et al., 1986; 
Heikkinen et al., 1998; Weltzin et al., 1999). Recent years have also seen an uptick in interest 
in probiotic therapies—including intranasally administered probiotics (Endam et al., 2021; 
Lambert et al., 2021; Marchisio et al., 2015; Mårtensson et al., 2017; Tran et al., 2022). 
Despite such investigational products being neither sterile (by definition) nor axenic, they 
confirm the intuitive result: mucosally delivered biologics are significantly safer than their 
injected counterparts.  
These general lessons also extend to the particular details of LMN-301’s formulation. 
Antibodies, VHHs, and other similar therapeutic proteins have been orally and intranasally 
administered in many human clinical trials without reports of SAEs or drug-related AEs 
(Carlton et al., 2018; Lochhead & Thorne, 2012; Nurbhai et al., 2019; Sarker et al., 2013). 
The safety, tolerability, and efficacy of intranasally administered therapeutic proteins against 
SARS-CoV-2 has been demonstrated in humans by at least six independent groups (de Vries 
et al., 2021; Haga et al., 2021; Huo et al., 2021; Imsuwansri et al., 2022; Nambulli et al., 
2021; Song et al., 2023). Remarkably, three of these groups achieved these results using 
simpler, less potent versions of the VHH antibodies within LMN-301. All were safe and well-
tolerated.  
This was not unexpected. Intranasal and mucosal delivery of therapeutic proteins has low 
potential for systemic exposure and immunogenicity (Hickey & Stewart, 2022). Historically, 
in passive nasal immunizations studies against coxsackie virus, rhinovirus, and respiratory 
syncytial virus, systemic reactions have not been observed (Buthala Ph.D. et al., 1970; 
Hayden et al., 1988; Rimensberger & Schaad, 1994). Inhalational administration of ALX-
0171, a nanobody directed against respiratory syncytial virus, did not induce systemic 
reactions in multiple studies in adults, children, and infants (De Bruyn et al., 2015). 
Recipients of intranasal LMN-301 in this study are healthy volunteers so are not expected to 
receive any treatment benefit. However, an effective COVID-19 preventative would offer a 
societal benefit. Considering the overall burden of the disease, the sponsor considers the 
potential benefits of participation to exceed the risks. 
 
 

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5 
STUDY OBJECTIVES AND ENDPOINTS 
The study objectives and endpoints are provided in Table 5-A below: 
Table 5-A  
LMN-301 COV01 Study Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the safety and 
tolerability of single and 
multiple doses of 
intranasally delivered 
LMN-301 
• 
Safety and tolerability of single and multiple doses of intranasally 
administered LMN-301 as measured by:  
o The occurrence of solicited AEs for 28 days after the first 
dose of LMN-301 
o The occurrence of unsolicited AE/SAEs for up to 28 days 
after the first dose of LMN-301 
o Discontinuation 
o Changes from baseline in vital signs, safety laboratory 
parameters, ECG parameters and nasal symptoms using the 
Sino-nasal outcome test  
Secondary 
To determine the 
persistence profile of LMN-
301 in the nasal mucosa 
following single and 
multiple doses 
• 
Detect the presence of LMN-301 in nasal mucosal lining fluid 
samples collected from study participants 
Exploratory 
To detect the presence of 
LMN-301 and anti-drug 
antibodies in serum 
• 
Detection of LMN-301 virus-binding proteins and anti-virus 
binding protein Immunoglobulin G (IgG) in serum samples 
 
 
 

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6 
STUDY DESIGN 
6.1 
Overall Design Type and Description 
This is a Phase I, open-label single site study of LMN-301 administered intranasally as single 
or multiple doses in healthy volunteers. 
This study will be conducted in two parts. 
Study volunteers will be screened for eligibility within 28 days of initiating study drug. Up to 
35 eligible volunteers will be enrolled in the study and sequentially assigned to the sentinel 
cohort (Part A, n=5) or to one of the three multiple-dose cohorts (Part B, n=10/group). 
6.2 
Part A (Sentinel Cohort) 
On Day 1, 5 participants will be administered a single dose of LMN-301 intranasally to each 
nostril at a fixed dose of 50 mg (25 mg in each nostril) using the Unidose (UDS) Powder 
Nasal Spray System device (Aptar). Eligible participants will be admitted to the clinic on Day 
1 prior to dosing, and will be observed as in-patients for 24 hours following study drug 
administration. Participants will be discharged on Day 2 and then followed on an outpatient 
basis for 14 days. Protocol-specified evaluations and procedures will be performed on Days 
1-2 and then weekly or bi-weekly. Participants will be required to return to the clinic for an 
outpatient visit on Day 8. Telephone follow-up will be conducted on Days 3 to 7, with an end 
of study telephone follow up on Day 14.   
There is no safety review committee for this study, however safety and tolerability data 
collected from the sentinel cohort participants will be reviewed by the principal investigator, 
the independent medical monitor, and the sponsor medical monitor, to decide whether to 
move forward with the multiple-dose cohorts (Part B). The discussion will include review of 
the study and individual stopping rules. 
The schedule of assessments (SoA) for the sentinel cohort (Part A) is presented in Table 
21-A, with a description of study schedule and procedures provided in Sections 10 and 11. 
6.3 
Part B (Multiple Dose) 
Up to 30 participants will be sequentially assigned to one of three dosing groups (10 
participants per group) starting with Group 1. Participants will be administered LMN-301 
intranasally to each nostril at a fixed dose of 50 mg (25 mg in each nostril) every third day for 
12 days (Group 1), every other day for 12 days (Group 2) or every day for 12 days (Group 3). 
All study participants will be observed in the clinic for 4 hours after the first dose. 
Participants will be monitored for the occurrence of any adverse events (AEs) and serious 
adverse events (SAEs). Vital signs, physical exams and safety/laboratory testing will be 
performed on Days 1, 3 or 4, 7 and 14. Participants will use a diary (paper or electronic) to 
record any symptoms from the first dose through 28 days after the first dose. 
Serum will be collected on Days 1 (baseline before dosing and 2 hours after dosing), 3 or 4, 7 
and 14 for analysis to detect systemic absorption of virus-binding proteins and anti-drug 
antibodies (ADA).  
Nasal mucosal lining fluid (MLF) samples will be collected using Synthetic Absorptive 
Matrix (SAM) strips (Nasosorption™ FX∙I, Hunt Developments (UK) Ltd, United Kingdom) 
from all participants on Day 1 (baseline before dosing and 2 hours after dosing), and on Days 

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3 or 4, 7 and 14. Nasal MLF samples will be sent to Lumen Bioscience (Seattle, WA, USA) 
for analysis. 
The schedule of assessments (SoA) for part B is presented in Table 21-B with a description of 
the study schedule and procedures provided in Sections 10 and 11. 
6.4 
Safety Review 
6.4.1 
Safety Review Committee 
There is no safety review committee for this study, however safety and tolerability data 
collected from the sentinel cohort participants will be reviewed by the principal investigator 
(PI), the independent medical monitor, and the sponsor medical monitor, either via email or 
meeting if required. The PI will decide whether to move forward with the multiple-dose 
cohorts (Part B) taking into account recommendations from the medical monitor and the 
sponsor medical monitor. The discussion will include review of the study and individual 
stopping rules. 
6.4.2 
Dose Stopping Rules 
AEs which will prompt stopping the investigational product administration for all subjects 
and review include: 
• Any individual experiencing any SAE considered at least possibly related to the 
investigational products; or 
• If two or more subjects experience the same or similar unanticipated adverse event 
that is Grade 3 in severity or higher; or 
• If the accumulation of SAEs and/or severe AEs collectively raises a safety concern in 
the opinion of the PI, Medical Monitor, or Sponsor. 
• If any individual experiences liver function tests or creatinine increased to 3 times the 
upper limit of normal; or 
• If any individual experiences significant spontaneous bleeding or platelet count < 100 
X 10^9/L; or 
• If any individual experiences coagulation disorders characterised by prolonged PT; or 
PTT or abnormal INR greater than 1.5 times the upper limit of normal 
• If any individual experiences neutrophil values < 1.0 x 109L 
The decision to restart the study will be made by consensus of the Independent Medical 
Monitor, the sponsor’s medical expert, and the Principal Investigator. The decision to stop the 
study will be communicated to the HREC and, similarly, the decision to re-start a study will 
also be communicated to the HREC. 
Administration of the investigational product will be discontinued for any subject that 
develops: 
• A serious adverse event considered at least possibly related to the investigational 
product; or 
• An adverse event that is Grade 3 or higher and considered at least possibly related to 
the investigational product; or 
• The Principal Investigator deems that stopping the investigational product 
administration is in the best interest of the subject. 

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6.5 
Participant Withdrawal Criteria 
Participants will be advised that they are free to withdraw from the study at any time for any 
reason or, if necessary, the PI (or delegate) may discontinue a participant from the study to 
protect the participant's health. A participant may voluntarily withdraw or be withdrawn from 
the study for reasons including, but not limited to, the following: 
• The need to take medication which may interfere with study measurements. 
• Intolerable/unacceptable AEs. 
• Positive test for Covid-19 
• Noncompliance of the participant with the protocol. 
• Withdrawal of consent; or 
• If, in the PI’s (or delegate’s) judgement, it is in the participant’s best interest. 
The Sponsor will be notified as soon as possible of any participant withdrawals. The date and 
reasons for withdrawal will be recorded in the eCRF and included in the final clinical study 
report, along with any AEs and necessary medical treatment (up until the point of study 
withdrawal). 
Any participant who prematurely discontinues study drug, should have, if possible, all 
scheduled safety assessments performed, including all follow-up visit assessments as 
scheduled. If a participant withdraws from the study, an attempt should be made to collect all 
remaining safety samples scheduled for that day. 
In the event that a participant is discontinued from the study due to an SAE, the PI (or 
delegate), or medically trained nominee, will evaluate the urgency of the event. If the 
situation warrants, the PI (or delegate), or medically trained nominee, will take appropriate 
diagnostic and therapeutic measures and attempt to notify the sponsor’s medical expert. If the 
situation is not an immediate emergency, the PI (or delegate), or medically trained nominee, 
at the clinical facility will attempt to contact the sponsor’s medical expert for consultation. 
No medical help, diagnosis, or advice will be withheld from the participant due to an inability 
to contact the sponsor’s medical expert. The participant will be encouraged to remain 
available for follow-up medical monitoring.  
Participants who withdraw from the study prior to treatment will be replaced according to 
recruitment and enrolment processes outlined in Section 7.3. 
6.6 
Suspension or Termination of the Study at the Investigational Site 
The Sponsor reserves the right to suspend or terminate an investigational site or this clinical 
study at any time. Reasons will be provided in the event of this happening. Reasons for 
termination may include, but are not limited to, the following:  
• Unacceptable safety and tolerability; 
• Serious or persistent noncompliance by the PI with the protocol, clinical research 
agreement, principles of the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice 
(GCP), or applicable regulatory requirements in conducting the study; 
• HREC decision to suspend or terminate approval for the PI; 
• Regulatory authority request for study suspension or termination; 
• Volunteer enrollment is unsatisfactory. 
The PI reserves the right to withdraw from the study for safety reasons at any time following 

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consultation with the Sponsor. 
6.7 
Treatment Allocation 
All study participants who sign an informed consent form at screening will receive a unique 
sequential number (i.e., a screening number). Participants will be allocated to the next 
available treatment group in the order they are screened. As this is an open-label study, no 
randomisation or blinding will occur. 
7 
PARTICIPANT SELECTION 
The screening period starts with the signing of the informed consent. During the screening 
period, inclusion/exclusion criteria for the study participation will be checked/tested. Subjects 
who meet all inclusion criteria and do not meet any exclusion criterion will be eligible to be 
enrolled. Those who are not eligible for enrollment or dosing will be considered as screening 
failures.  Data for screen failure reason, eligibility criteria, and demography will be captured 
on the appropriate screening and enrolment log. 
Assessments may be repeated once, if abnormal values were recorded in the first instance, at 
the discretion of the PI. Values outside of the ranges specified in the criteria below may be 
considered acceptable if determined by the Investigator (in conjunction with the study 
medical monitor) to be not clinically significant (NCS).   
Unless specifically defined below, inclusion and exclusion criteria are to be assessed at 
screening and again on Day 1, prior to dose administration.   
7.1 
Inclusion Criteria 
Individuals must meet all the following criteria to be eligible to participate in this study: 
1. Adult (between 18 and 65 years of age) at screening  
2. BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening. 
3. General good health, without significant medical illness or abnormal physical 
examination findings per investigator discretion. 
4. No clinically significant laboratory values at screening for haematology, serum 
chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat test 
is allowed at the investigator’s discretion.  
5. Normal electrocardiogram (ECG) with no QTcF prolongation.  
6. Must have provided written informed consent to participate in the clinical trial before 
any study-related activities are carried out and, in the Investigator’s opinion, must be 
able to understand the full nature and purpose of the trial, including possible risks and 
adverse effects.  
7. In the investigator’s opinion, participant is willing and able to comply with all study 
assessments and adhere to the protocol schedule and restrictions. 
8. Female volunteers: 
a. Must be of non-child-bearing potential, i.e., surgically sterilized 
(hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 
weeks before the screening visit or postmenopausal (where postmenopausal is 
defined as no menses for 12 months without an alternative medical cause 
(confirmed with FSH testing), or 

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b. If of child-bearing potential, must have a negative serum pregnancy test at 
screening and negative urine pregnancy test before the first study drug 
administration. They must agree not to attempt to become pregnant, must not 
donate ova, and must agree to use a highly effective method of contraception 
from signing consent, throughout the study and for at least 30 days after the 
last dose of study drug. For contraception guidelines see Appendix 4. 
9. Male volunteers must agree not to donate sperm and if engaging in sexual intercourse 
with a female partner who could become pregnant, must agree to use a condom in 
addition to having the female partner use a highly effective contraceptive method 
(Appendix 4) from signing consent, during the study, and at least 90 days after the last 
dose of study drug. 
7.2 
Exclusion Criteria 
Individuals will be excluded from this study if they meet any of the following criteria:  
1. History or presence of clinically significant disease, including (but not limited to) 
clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, 
gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric 
disease, including any acute illness or surgery within the past 3 months prior to 
screening determined by the PI to be clinically relevant. 
2. Known allergy or previous anaphylaxis to any components of the investigational 
product 
3. Allergies, history of allergic disease or chronic respiratory diseases including mild 
asthma. History of childhood asthma or childhood allergies are not exclusionary.  
4. History of nasal or upper respiratory pathology or abnormalities 
5. Ongoing, defined as within 30 days of dosing through end of follow-up, usage of 
nasal spray or nasal drops  
6. Treatment with an experimental device or compound within 30 days of the first dose 
of study drug.  
7. Treatment within 30 days of the first dose of the study medication or planned use 
within the study period with immunomodulator or immunosuppressant agent or 
medicines (over the counter [OTC], herbal, prescription, or supplement) with 
significant activity in the respiratory tract. 
8. Pregnancy, anticipated pregnancy, or breastfeeding/lactating 
9. Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per week 
or more than 4 standard drinks on any one day, where 1 standard drink is 10 g of pure 
alcohol) within 3 months prior to screening. 
10. Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at 
investigator discretion. Tobacco or nicotine consumption is not permitted from 
screening and until the end of follow-up.  
11. Positive alcohol breath test. Repeat test is allowed at investigator discretion.  
12. Individuals unable or unwilling to provide adequate informed consent  
13. COVID-19 positive  
14. Positive test results for active human immunodeficiency virus (HIV), hepatitis B 
surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening. 

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7.3 
Participant Replacement 
Replacement of participants is allowed if a participant withdraws or is withdrawn prior to the 
commencement of dosing.  
Participants who withdraw or are withdrawn from the study after administration of the first 
dose for reasons other than occurrence of an SAE, may be replaced at the discretion of the PI 
(or delegate) and following consultation with the Sponsor.  
Any participants enrolled as replacements will be allocated to the same treatment group as the 
participant that is being replaced. 
8 
INVESTIGATIONAL PRODUCT  
8.1 
Description of Investigational Product 
The IP to be used in this clinical study is LMN-301 (active ingredient), formulated as a spray 
dried powder for intranasal delivery, at a dose of 25 mg intranasally into each nostril (50 mg 
total dose).  
LMN-301 consists of spray-dried extract of biomass of two strains of spirulina (Arthrospira 
platensis) —SP1844 and SP1835—each of which has been engineered to intracellularly 
express one of the engineered therapeutic antibody-like fusion proteins that binds and inhibits 
SARS-CoV-2 (pp1116 and pp1107, respectively). The engineered virus-binding proteins are 
derived in part from the antigen-binding domains of camelid single-domain antibodies (also 
known as VHHs or nanobodies).  
For convenient intranasal delivery, LMN-301 dry powder is prepared by isolating the soluble 
protein fraction of spirulina expressing the binding protein constructs, diafiltration and buffer 
exchange to formulate the product with glycine and trehalose, then spray drying. The spray 
dried final powder will be delivered to the intranasal cavity of patients in the Unidose (UDS) 
Powder Nasal Spray System device (Aptar, Crystal Lake, IL, USA) (the plume will extend 
into the entire intranasal cavity). The devices are disposable and for single use. One device 
per nostril per timepoint will be used. 
8.2 
Supply, Packaging and Labelling 
The study drug, LMN-301, will be supplied by Lumen Bioscience, Inc. (Seattle, WA, USA). 
LMN-301 doses (25 mg) are packaged into each Aptar Unidose device (Aptar, Crystal Lake, 
IL) for intranasal administration. The Unidose devices will be individually packaged in 
labelled mylar bags (2 devices per bag), and labelled appropriately.  
The manufacturer will provide the site (or site pharmacy) with a sufficient quantity of study 
drug (LMN-301) for the conduct of the study. The investigational pharmacy will dispense 
LMN-301 according to the Pharmacy Manual. 
Study drugs will be labelled according to current GMP (cGMP), as adopted in each 
country/region. 
Standard operating procedures will be followed for the receipt, handling and accountability of 
the study drugs. 
Additional details are provided in the study Pharmacy Manual. 

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8.3 
Storage 
All investigational products will be kept in a locked area with limited access. Unidose (UDS) 
Powder Nasal Spray System devices will be provided in labelled mylar bags and should be 
stored at room temperature, 59-77°F (15-25°C) and protected from moisture, light, and 
extreme heat during storage. The site must maintain a temperature log for all study drugs held 
on site, and the Sponsor must be contacted as soon as possible for any temperature 
excursions.  
The investigational product contains no preservatives. Any damaged or used devices should 
be returned to the investigational pharmacy and discarded using appropriate drug disposal 
procedures and documented. Two Unidose Powder devices containing the IP will be 
packaged in each mylar bag with a desiccant packet.  
Only participants enrolled in the study may receive the investigational product in accordance 
with all applicable regulatory requirements. Upon the completion of the study, this material 
will be subjected to final inspection and reconciliation. At that time, all unused, partially 
used, and fully used devices along with a packing slip must be destroyed as per the pharmacy 
manual. Documentation of destruction will be retained by the investigational pharmacy with 
the study files. 
8.4 
Investigational Product Dispensing 
In accordance with all applicable regulatory requirements and the protocol, only participants 
enrolled in the study may receive study drug (LMN-301). Only authorised and trained site 
staff may dispense the study drug. 
The PI is responsible for ensuring that all study drugs are dispensed in accordance with the 
protocol and only to participants enrolled in the study. 
Upon receipt of a prescription/authorisation from the Investigator (or delegate), the study 
pharmacist (or delegate) will dispense the doses of LMN-301. 
At the time of dispensing the pharmacist (or delegate) will complete the applicable fields on 
the label. 
8.5 
Administration of Investigational Product 
A Unidose Nasal Device (Aptar Pharma) will be used to deliver the doses of LMN-301 
(Figure 8-A). The Sponsor will provide the Aptar Unidose Nasal Devices pre-filled with 
LMN-301.  
 

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Figure 8-A  Unidose Nasal Device 
 
 
Each Unidose nasal device delivers a dose of 25 mg. Detailed instructions are provided in the 
study Pharmacy Manual.  
The total dose to be delivered will be divided equally across both nostrils, with a total of 1 
actuation per nostril required for each dose, i.e., a total dose of 50 mg (See Table 8-A).  
All dosing will take place in the clinical facility under the supervision of site staff.  
Participants in study Part A (sentinel cohort) will be observed as in-patients for 24 hours after 
administration of study drug.  
Participants in study Part B (multiple dose cohort) will be observed on site for 4 hours after 
administration of the first dose.  
• Participants in Group 1 will return to the site every 3rd day (Days 4, 7 and 10) for 
dosing and safety monitoring 
• Participants in Group 2 will return to the site every 2nd day (Days 3, 5, 7, 9 and 11) for 
dosing and safety monitoring 
• Participants in Group 3 will return to the site daily (Days 2 to 12) for dosing and 
safety monitoring 
Details of dose administration will be recorded in the eCRF.  
Table 8-A  
LMN-301 Dosing of Study Participants in Study Parts A and B 
Cohort No. 
Number of 
Participants 
to be Dosed 
with LMN-
301 
Dose 
delivered 
per 
actuation  
Number of 
actuations per 
nostril (to be 
administered 
in each nostril) 
Total 
Fixed 
Dose  
Dosing 
Frequency 
Total 
number 
of doses 
Part A (Single dose) 
Sentinel 
cohort 
5 
25 mg 
1 
50 mg 
Once only 
1 
Part B (Multiple dose) 
Group 1 
10 
25 mg 
1 
50 mg 
Every 3rd 
day, for 12 
days 
4 

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Cohort No. 
Number of 
Participants 
to be Dosed 
with LMN-
301 
Dose 
delivered 
per 
actuation  
Number of 
actuations per 
nostril (to be 
administered 
in each nostril) 
Total 
Fixed 
Dose  
Dosing 
Frequency 
Total 
number 
of doses 
Group 2 
10 
25 mg 
1 
50 mg 
Every 2nd 
day, for 12 
days 
6 
Group 3 
10 
25 mg 
1 
50 mg 
Daily, for 12 
days 
12 
8.6 
Accountability of Investigational Product Supplies 
All study drug supplied is for use only in this clinical study and should not be used for any 
other purpose. 
The PI (or delegate) is responsible for study drug accountability, reconciliation, and record 
maintenance at the clinical facility. In accordance with all applicable regulatory requirements, 
the PI or designated trained site staff must maintain study drug accountability records 
throughout the course of the study. This person will document the amount of study drug 
received from the Sponsor (or designee) and the amount dispensed to, administered to, and 
returned by participants, as applicable. The shipment/receipt records as well as records of 
dispensing, administration and return will be verified by a second member of the site staff. 
The PI (or designated trained site staff) is responsible for assuring the retrieval of all left-over 
study drug supplies following administration to participants. 
Used packages of the study drug will be retained and sequestered per participant and made 
available to the CRA during study drug reconciliation.  
When requested in writing by the Sponsor and following review and reconciliation of study 
drug accountability, unused study drug supplies may be returned to the Sponsor or destroyed 
by the PI (or delegate), provided destruction does not expose humans to risks from the study 
drugs. Records shall be maintained of the return or destruction of the study drug materials. 
These records must show the identification and quantity of each unit returned or disposed of, 
the method of destruction (taking into account the requirements of local law), and the person 
who returned or disposed of the study drug materials. Such records must be submitted to the 
Sponsor. 
 

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9 
PRIOR/CONCOMITANT MEDICATIONS AND OTHER RESTRICTIONS 
9.1 
Prior and Concomitant Medications 
Subjects will be monitored throughout the study for the use of concomitant medications. A 
concomitant medication is defined as any non-study medication taken after the first dose of 
study drug (including where these medications were commenced prior to first dose 
administration and continued after first dose administration) through to the final follow-up 
visit. A prior medication is defined as any non-study medication taken within 28 days prior to 
screening but ceased prior to the first dose of study drug. 
For both study parts, only concomitant medications approved by the study physician should 
be used during the study. Subjects taking regular medication (e.g., contraceptives) prior to 
enrolment will be allowed to continue unless it is specifically excluded as part of the 
inclusion/exclusion criteria. Subjects requiring non-approved or excluded medications will 
not be eligible for enrolment. Approved medications that were being taken prior to and 
during the trial will be documented. 
Use of the following medications is prohibited during the study: 
• Ongoing (defined as within 30 days of the first dose through to the end of follow-up) 
use of nasal spray or nasal drops  
• Treatment with an experimental device or compound within 30 days of the first dose 
of study drug  
• Treatment within 30 days of the first dose of the study medication or planned use 
within the study period with an immunomodulator or immunosuppressant agent or 
medicines (over the counter [OTC], herbal, prescription, or supplement) with 
significant activity in the respiratory tract. 
If the need for concomitant medication arises to treat an AE, the Investigator should make 
decisions on medication use based on the participant and clinical factors.  
If a concomitant medication is started during the study, a decision whether the participant 
may continue in the study will be made by the PI (or delegate), in consultation with the 
sponsor’s medical expert. 
Any non-study medication that is taken by or administered to a participant from 28 days prior 
to screening through their final study visit must be recorded in the eCRF. The entry must 
include the medication name, indication, dose, dose regimen, route of administration, and 
start/stop dates. 
9.2 
Tobacco and Alcohol 
Participants must have a negative drugs of abuse urine test and alcohol breath test at 
Screening and on Day 1 prior to dosing, and must abstain from recreational drug use 
throughout the study.  
Use of tobacco products or nicotine-containing products (including smoking cessation aids 
such as gum or patches), are prohibited from Screening and until their last study visit.  
9.3 
Contraception 
Female participants of childbearing potential, must agree not to attempt to become pregnant, 

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must not donate ova, and if not exclusively in a same-sex relationship, use adequate 
contraception (Appendix 4) from signing the consent form until at least 30 days after the last 
dose of study drug. Additionally, female participants of childbearing potential must use 
adequate contraception for at least 1 month prior to screening. 
Male participants, must agree not to donate sperm and if engaging in sexual intercourse with 
a female partner who could become pregnant, must agree to use a condom plus a have the 
female partner use a highly effective contraceptive method (Appendix 4) from signing the 
consent form until at least 90 days after the last dose of study drug. 
9.4 
Fasting 
There are no fasting requirements in this study. Standard meals will be provided to 
participants during the confinement period and also during extended outpatient visits, as 
appropriate. 
9.5 
Blood Donation 
All study participants will be advised not to donate blood or blood products (> 470 mL) 
within 3 months prior to screening and for 3 months following the final follow-up visit.  
 
 

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10 
STUDY SCHEDULE 
As presented in the study SoA (refer to Appendix 1, Appendix 2 and Appendix 3), Screening, 
Treatment, Follow-up and End of study assessments will be performed for all participants. 
10.1 Screening 
All participants (Part A and Part B) will be screened for eligibility within 28 days of the first 
dose of study drug. The following procedures will be performed at screening: 
• Informed consent 
• Inclusion/exclusion criteria 
• Demographics (age, race, sex, ethnicity) 
• Height and weight 
• Medical/surgical history, comorbidities 
• Prior and concomitant medications 
• Serum pregnancy test (females of child-bearing potential only) 
• Collect blood for follicle-stimulating hormone levels (post-menopausal women only) 
• Urine tox screen for drugs of abuse 
• Alcohol breath test 
• Physical examination 
• Vital signs (systolic and diastolic blood pressure, pulse rate, oral temperature, 
respiration rate) 
• Twelve-lead ECG 
• Collect urine for urinalysis 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR  
• Collect blood for viral serology testing (HIV antibody, HBsAg, HCV) 
• Perform Sino-Nasal Outcome Test 
• COVID-19 RAT test 
10.2 Part A Sentinel Cohort (open-label, one fixed dose) 
In Part A, 5 sentinel participants will be observed for 24 hours as inpatients, and then 
followed for 14 days. Protocol-specified evaluations and procedures will be performed on 
Day 1-2 and weekly or bi-weekly as outlined below and in the SoA (Appendix 1).  
10.2.1 
Day 1 Inpatient 
Eligible volunteers will be admitted to the research unit. The following procedures will take 
place on Day 1: 
• Record concomitant medications before and after drug administration 
• Review inclusion/exclusion criteria before dosing 
• Urine pregnancy test (females of child-bearing potential only) before dosing 
• COVID-19 RAT test before dosing 
• Urine tox screen for drugs of abuse before dosing 
• Alcohol breath test before dosing 
• Collect whole blood for hematology before dosing 
• Collect serum for chemistry before dosing 

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• Collect blood for PT, APTT INR before dosing 
• Perform a targeted physical examination before dosing 
• Perform a nasal examination within 1 hour before and 3 hours after drug 
administration 
• Vital signs within 2 hours before and at 30 minutes, 1 hour and 4 hours after drug 
administration 
• Collect serum for drug detection before and 2-hours after drug administration 
• Collect serum for anti-drug antibodies before and 2 hours after drug administration 
• Collect nasal mucosal lining fluid (MLF) samples before and 2-hours after drug 
administration 
• Administer study drug by intranasal delivery to each nostril using a unidose powder 
device 
• Perform Sino-Nasal Outcome Test at 2 hours after drug administration 
• Record solicited AEs (stuffy nose, runny nose, sneezing, nasal irritation, nasal 
tenderness/pain, loss of smell, sore throat scratchy throat, cough) and unsolicited 
AEs/SAEs 
• Participants will be provided with a diary (paper or electronic) to record any solicited 
and/or unsolicited AEs daily, and to record concomitant medication usage. 
10.2.2 
Day 2 Inpatient 
• Perform a targeted physical examination  
• Vital signs 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR 
• Collect serum for drug detection 
• Collect serum for anti-drug antibodies 
• Collect nasal mucosal lining fluid (MLF) sample 
• Record solicited AEs and unsolicited AEs/SAEs 
• Review diary 
• Record concomitant medications 
• Discharge participants 
10.2.3 
Days 3-7  
Research staff will perform daily telephone calls to the patient during this period to assess the 
emergence of AEs (solicited and unsolicited) and concomitant medication usage (recorded in 
the diary). 
10.2.4 
Day 8 Outpatient Visit 
• Perform a targeted physical examination  
• Vital signs 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR 
• Collect serum for drug detection 
• Collect serum for anti-drug antibodies 

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• Collect nasal mucosal lining fluid (MLF) sample 
• Perform Sino-Nasal Outcome Test 
• Review diary 
• Record solicited AEs and unsolicited AEs/SAEs 
• Record concomitant medications 
10.2.5 
Day 14 Outpatient Visit (End of Study) 
• Perform a targeted physical examination  
• Vital signs 
• Record solicited AEs and unsolicited AEs/SAEs 
• Record concomitant medications 
• Twelve-lead ECG 
• Urine pregnancy test (WOCBP only) 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR 
• Urine collection for urinalysis  
• Site staff to collect diary 
10.3 Part B Multi-Dose Cohort (Multi-dose, Open-label) 
The safety data from the sentinel cohort will be reviewed by the principal investigator, the 
medical monitor, and the sponsor study physician to make a decision whether to move 
forward with the multiple dose cohorts (Part B). As part of the decision process, the principal 
investigator, the independent medical monitor, and the sponsor study physician will consider 
the study and individual stopping rules (see Section 6.4.2). 
In Part B, 30 participants will be administered LMN-301 (n=10/group) intranasally into each 
nostril every third day for 12 days (Group 1), every other day for 12 days (Group 2) or every 
day for 12 days (Group 3).  
Participants will be observed in the clinic for 4 hours after the first dose. Protocol-specified 
evaluations and procedures will be performed as outlined below and in the SoA (Appendix 
1).  
Nasal mucosal lining fluid (MLF) samples will be collected from all participants on Day 1 
(baseline before dosing and 2 hours after dosing), and on Days 3 or 4, 7 and 14. Nasal MLF 
samples will be sent to Lumen Bioscience for analysis.  
Participants will use a diary to record concomitant medication usage and any symptoms from 
the first dose through Day 28 after the first dose. 
10.3.1 
Day 1  
Eligible volunteers will come into the clinic on Day 1 and the following procedures will take 
place on Day 1: 
• Record concomitant medications before and after dosing 
• Review inclusion/exclusion criteria before dosing 
• Perform urine pregnancy test before dosing 
• Urine tox screen for drugs of abuse 

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• Perform alcohol breath test 
• COVID-19 RAT test before dosing  
• Urine pregnancy test before dosing (females of child-bearing potential only) 
• Collect whole blood for hematology before dosing 
• Collect serum for chemistry before dosing 
• Collect blood for PT, APTT, INR before dosing 
• Perform a targeted physical examination within 1 hour before drug administration 
• Perform a nasal examination within 1 hour before and 3 hours after drug 
administration 
• Vital signs within 1 hour before and at 15 minutes, 30 minutes, 1 hour and 4 hours 
after drug administration 
• Collect serum for drug concentration before and 2 hours after drug administration 
• Collect serum for anti-drug antibodies before and 2 hours after drug administration 
• Collect nasal MLF sample before drug administration and 2 hours after dosing 
• Participants in all dosing groups will be administered study drug by intranasal 
delivery into each nostril using the Aptar Unidose device. 
• Perform Sino-Nasal Outcome Test at 2 hours after drug administration 
• Participants will be observed in the clinic for 4 hours after dosing. 
• Record solicited AEs and unsolicited AEs/SAEs  
• Participants will be provided with a diary to record any solicited and/or unsolicited 
AEs and concomitant medication usage daily, from Days 1-28 (inclusive). 
10.3.2 
Day 2-12 Treatment Phase and Clinic Visits  
Group 1 
• Participants will attend the clinic every third day (Days 4, 7 and 10).  
• A targeted physical exam (See Section 11.11) will be performed within 1 hour prior to 
dose administration on Days 4, 7 and 10 
• Vital signs will be performed within 1 hour prior to dose administration on Days 4, 7 
and 10 
• Blood collection for hematology and coagulation markers (PT, APTT, INR), 
collection of serum for chemistry will be performed within 1 hour prior to dose 
administration on Days 4 and 7 
• Blood samples for investigational drug detection and anti-drug antibodies will be 
collected any time prior to drug administration on Days 4 and 7. 
• Study drug will be administered under supervision in the clinic by intranasal delivery 
into each nostril every third day (Days 4, 7 and 10) using the Aptar Unidose device. 
• A nasal examination will be performed 3 hours after drug administration on Day 4, 7 
and 10 
• A COVID-19 RAT test will be performed before dosing on Day 4, 7 and 10. 
• A Sino-Nasal Outcome Test on will be performed on Day 7 at 2 hours after drug 
administration. 
• Intranasal MLF samples will be collected prior to dosing on Day 4 and Day 7. 
• Subject diaries will be reviewed by study staff at each clinic visit. 
• Record solicited AEs and unsolicited AEs/SAEs daily 
• Record concomitant medication use daily 

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Group 2 
Participants will attend the clinic every other day (Days 3, 5, 7, 9 and 11). 
• A targeted physical exam will be performed within 1 hour prior to dosing on Days 3, 
7 and 11. 
• Vital signs will be assessed within 1 hour prior to dosing on Days 3, 7 and 11. 
• Blood collection for hematology and coagulation markers (PT, APTT, INR), 
collection of serum for chemistry within 1 hour prior to dosing on Days 3 and 7. 
• Blood samples for investigational drug detection and anti-drug antibodies will be 
collected on Day 3 and Day 7, any time prior to drug administration. 
• Study drug will be administered under supervision in the clinic by intranasal delivery 
into each nostril every other day (Days 3, 5, 7, 9 and 11) using the Aptar Unidose 
device. 
• A nasal examination will be performed 3 hours after drug administration on Day 3, 7 
and 11. 
• A COVID-19 RAT test will be performed before dosing on Day 3, 7 and 11. 
• A Sino-Nasal Outcome Test on will be performed on Day 7 at 2 hours (±15 mins) 
post-dose. 
• Intranasal MLF samples will be collected prior to dosing on Day 3 and Day 7. 
• Subject diaries will be reviewed by study staff at each clinic visit. 
• Record solicited AEs and unsolicited AEs/SAEs daily 
• Record concomitant medication use daily 
Group 3 
• Participants will attend the clinic daily (Days 2-12).  
• A targeted physical exam will be performed within 1 hour prior to dosing on Days 3, 
7 and 11. 
• Vital signs will be assessed within 1 hour prior to dosing on Days 3, 7 and 11  
• Blood collection for hematology and coagulation markers (PT, APTT, INR), 
collection of serum for chemistry within 1 hour prior to dosing on Days 3 and 7. 
• Blood samples for investigational drug detection and anti-drug antibodies will be 
collected on Day 3 and Day 7, any time prior to drug administration. 
• Study drug will be administered under supervision in the clinic by intranasal delivery 
into each nostril daily (Days 2-12) using the Aptar Unidose device. 
• A nasal examination will be performed 3 hours after drug administration on Day 3, 7 
and 11. 
• A COVID-19 RAT test will be performed before dosing on Day 3, 7 and 11. 
• A Sino-Nasal Outcome Test on will be performed on Day 7 at 2 hours (±15 mins) 
post-dose. 
• Intranasal MLF samples will be collected prior to dosing on Day 3 and Day 7. 
• Subject diaries will be reviewed by study staff at each clinic visit. 
• Record solicited AEs and unsolicited AEs/SAEs daily 
• Record concomitant medication use daily 
10.3.3 
Day 14 Follow-up visit  
Participants will attend the research unit on Day 14 and the following procedures will take 
place: 
• Recording concomitant medications 

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• A COVID-19 RAT test 
• Targeted physical examination 
• Vital signs 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR 
• Collect serum for drug concentrations 
• Collect serum for anti-drug antibodies 
• Collect nasal mucosal lining fluid (MLF) sample  
• Perform Sino-Nasal Outcome Test 
• Review diary 
• Record AEs/SAEs 
10.3.4 
Days 15-17 
Solicited and unsolicited AEs/SAEs and concomitant medications will be recorded daily 
using the participant diary 
10.3.5 
Day 28 End of Study Visit  
Participants will come into the research unit on Day 28 and the following procedures will 
take place: 
• Recording concomitant medications 
• Vital signs 
• Twelve-lead ECG 
• Perform Sino-Nasal Outcome Test 
• Collect whole blood for hematology 
• Collect serum for chemistry 
• Collect blood for PT, APTT, INR 
• Collect urine for urinalysis 
• Record AEs/SAEs 
• Review and collect diary 
• Urine pregnancy test (females of child-bearing potential only) 
11 
STUDY PROCEDURES 
For the exact timing of each procedure, please refer to the study SoA (refer to Appendix 1, 
Appendix 2 and Appendix 3). Clinical staff are required to perform assessments at the 
nominated timepoints within the time windows indicated in the SoA. Actual times of 
procedures for each participant may vary depending on scheduling and will be recorded in the 
eCRF. In the event of multiple procedures scheduled at the same time, the order, where 
possible, will be (1) vital signs, (2) 12-lead ECG, (3) PK/PDc sampling (4) safety laboratory 
blood sampling (5) all other procedures. 
Where required, the timing of post-dose procedures will be in reference to administration of 
the last actuation completed. 
11.1 Informed Consent 
The Information and Informed Consent Form (ICF) will be provided to participants at 

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Screening and signed prior to any study procedures being performed. Investigators at each 
site are responsible for maintaining a record of all participants consented, including both 
those who enter the study and those who do not. 
11.2 Demographics 
Demographic information collected will include age, sex, race, and ethnicity. Where local 
regulations do not permit certain demographic data to be collected, collection of those data 
will not be required. 
11.3 Medical and Surgical History 
A full medical history will be obtained at Screening (to be updated on Day 1, prior to dose 
administration), including medication history and drug allergies. Medical history can be 
obtained through participant interview and medical records. 
All findings will be recorded on the Medical History eCRF. 
11.4 Prior and Concomitant Medications and Therapies 
All medications and therapies administered to participants between signing the ICF and the 
final follow up visit will be recorded in the participant’s eCRF. The name, dose, route of 
administration, dosing schedule, indication and start and stop dates of all medications and 
therapies must be recorded. Dates of changes to medications (commencement, cessation 
and/or alteration in dose or schedule) should also be recorded. Medications include 
prescription and over the counter medications (including herbal products, vitamins, 
nutritional supplements). For participants entering on a stable dose of permitted medication, 
any change in dose should also be recorded. 
11.5 Height and Weight 
Body height (centimetres) and weight (kilograms) will be measured, and body mass index 
(BMI) will be calculated. Height should ideally be measured on a wall-mounted stadiometer. 
Weight should be measured in light-weight clothing, without shoes. 
11.6 COVID-19 Rapid Antigen Test 
A COVID-19 rapid antigen test (RAT) will be performed at the timepoints indicated in the 
schedule of assessments. Participants who return a positive result will be withdrawn from the 
study. 
11.7 Follicle-Stimulating Hormone 
Female participants who report as postmenopausal (where postmenopausal is defined as no 
menses for 12 months without an alternative medical cause) will have a serum FSH test at 
screening. If serum FSH levels are below the cut-off limit as defined by the local testing 
laboratory, participants will be considered to be of childbearing potential and will be required 
to use appropriate contraception for the duration of the study. 
11.8 Pregnancy Test 
Female participants of child-bearing potential will have a serum hCG pregnancy test during 
Screening. A urine hCG pregnancy test will be conducted on Day 1 as per the SoA. If any of 

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the urine hCG tests are positive, pregnancy will be confirmed by a serum hCG test. In 
instances of a positive pregnancy result at any time point, the participant will be withdrawn 
from the study. Participants withdrawn from the study due to pregnancy may be replaced at 
the discretion of the PI. Refer to Section 12.7 for pregnancy reporting guidelines. 
11.9 Serology 
HIV antibody, HBsAg, and HCV antibody will be measured at screening. Participants with a 
positive result will not be eligible to participate in the study. Investigators must ensure 
compliance with local governing legislation and reporting requirements associated with 
communicable diseases. 
11.10 Clinical Laboratory Assessments 
Blood samples will be collected for haematology, clinical chemistry and coagulation safety 
assessments; urine samples will be collected for urinalysis, and urine drugs of abuse testing. 
An alcohol breath test will be performed as indicated in the schedule of assessment for each 
study part. 
Tests performed by the local laboratory are described in Appendix 5. All abnormal 
assessments assessed as clinically significant (CS) by the PI will be repeated. Abnormal 
assessments that are not CS may be repeated at discretion of the PI. Note: Any deviation in 
laboratory values that are confirmed on re-examination to be CS and (in the opinion of the PI 
or medically qualified nominee) would jeopardise the safety of the participant or impact on 
the validity of the study results), will result in exclusion/withdrawal of that participant. 
All safety laboratory assessments will be assessed by a certified local laboratory, using that 
laboratory’s normal ranges. The Investigator must review the laboratory report, document 
this review, and record any CS changes occurring during the study in the AE section of the 
eCRF.  
11.11 Physical Examination 
Screening physical examinations will include, at a minimum, assessment of the following: 
general appearance, head, ears, eyes, nose and throat, neck (including thyroid and lymph 
nodes), respiratory system, cardiovascular system, gastrointestinal system, renal system, 
neurological system, musculoskeletal system, skin, and any other focused assessments 
suggested by the presence of specific symptoms.  
Targeted physical examination will include general appearance, head, ears, eyes, nose and 
throat, respiratory system and any other focused assessments suggested by the presence of 
specific symptoms. 
All physical examinations will be conducted by a licensed physician within the time windows 
specified in the SoA. Physical examinations may also be performed at various unscheduled 
timepoints if deemed necessary by the Investigator.  
All CS findings post-dose will be recorded as AEs.   
11.12 Nasal Examination 
A macroscopic nasal examination will be performed by conventional anterior rhinoscopy 
with otoscope with attached otic speculum to assess swelling of the mucosa, erythema, and 

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secretions at the time of physical examination, at time points specified in the Schedule of 
Assessments (Appendix 21.1).  
All events will be graded for severity as mild, moderate, or severe in the opinion of the 
investigator (or delegate) (Section 12.2.112.2.1) and recorded as AEs. 
11.13 Vital Signs 
Vital signs assessments will include systolic and diastolic blood pressure, pulse rate, 
respiratory rate (RR), and oral temperature. Participants should be resting in a supine/semi-
supine position for at least 5 minutes prior to and during vital signs measurements.  
Vital signs assessments may be repeated once, if abnormal values (outside of site’s normal 
ranges) were recorded in the first instance, at the discretion of the PI (or delegate). 
All CS findings post-dose will be recorded as AEs.  
Site normal vital signs ranges are as follows:  
• Temperature: ≥35.5 °C to ≤37.7 °C 
• Pulse Rate: ≥45 bpm to ≤100 bpm 
• Respiratory Rate: ≥12 to ≤22 breaths/min 
• Systolic Blood Pressure: ≥90 mmHg to ≤160 mmHg 
• Diastolic Blood Pressure: ≥50 mmHg to ≤95 mmHg 
11.14 Electrocardiogram 
12-lead ECG will be performed at Screening, and at End of Study for both study parts. At 
each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate 
separated by at least 1 minute and the full set of triplicates completed within 5 minutes. The 
mean value for the triplicate will be utilised. Each ECG will be conducted in a supine (or 
semi-supine) position after the participant has been resting for at least 5 minutes in a quiet 
setting without distractions (e.g., television, mobile phones). 
Site normal ranges for ECG parameters are as follows: 
• HR: 45 bpm to 100 bpm 
• PR: ≥120 msec to ≤220 msec 
• QRS: <120 msec 
• QTcB & QTcF: ≤470 msec (females) or ≤450 msec (males) 
ECGs will be interpreted, signed, and dated by the PI (or delegate). The ECGs will be 
classified as normal, abnormal NCS, or abnormal clinically significant. In addition, ECG 
parameters of ventricular HR, PR interval, QRS duration, QTcB and QTcF will be noted on 
the eCRF.  
Abnormal ECGs that are clinically significant will be repeated. In the case of evident bad 
quality (e.g., muscle tremor) of the tracing, an ECG will be repeated. Abnormal ECGs that 
are NCS may be repeated in at the Investigator’s discretion. Repeat assessments will be 
performed in triplicate. 

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Additional ECGs may be performed at any time during the study as required, at the discretion 
of the PI (or designee). 
All CS findings post-dose will be recorded as AEs. 
11.15 Nasal Symptoms by Sino-Nasal Outcome Test 
Nasal symptoms and social/emotional consequences will be assessed using the Sino-nasal 
outcome test (SNOT-22) at different timepoints, as presented in the SoA (Appendix 
21.121.1). Participants will be asked to rate their experience of each of 22 listed symptoms on 
a scale of 0-5 based on symptoms over the preceding 2 weeks. The rating scale is as shown 
below:  
0 = No Problem 
1 = Very Mild Problem 
2 = Mild or slight Problem 
3 = Moderate Problem 
4 = Severe Problem 
5 = Problem as bad as it can be 
Participants will also be asked to identify up to 5 of the most important issues affecting them, 
from the list of 22 symptoms. 
11.16 Study Diary 
Participants will be provided with a study diary on Day 1 to record any solicited and/or 
unsolicited AEs, and to record concomitant medication usage. Participants will be instructed 
on use of the diary by site staff during in-person visits.  
11.17 Pharmacokinetic Assessments 
11.17.1 
Blood 
Whole blood samples will be collected and processed to obtain serum for the determination 
of LMN-301 levels on Days 1 (pre- and post-dose), 2 and 8 for the sentinel cohort and on 
Days 1 (pre- and post dose), 3 or 4, 7 and 14 for the multi-dose cohort. Serum samples will be 
stored at -80°C until shipped to Lumen Bioscience (Seattle, USA) for subsequent processing 
and analysis. With the participant’s approval, de-identified leftover samples may be stored at 
Lumen Bioscience indefinitely and used for future research studies related to the 
development of LMN-301. This future research will not include genomic sequencing. 
Detailed instructions for the collection, processing, and shipment of samples for LMN-301 
PK will be described in the study Laboratory Manual.  
11.17.2 
Nasal Secretions 
Nasal mucosal lining fluid (MLF) samples will be collected on Days 1 (pre- and post-dose), 2 
and 8 for the sentinel cohort and on Days 1 (pre-and post-dose), 3 or 4, 7 and 14 for the 
multi-dose cohort. Sampling will alternate between right and left nostrils during sequential 
sample collection time points. 
MLF samples will be collected using the Nasosorption™ FX∙I device (Hunt Developments 

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(UK), United Kingdom). This device consists of a synthetic absorptive matrix (SAM™) swab 
to absorb MLF from the mucosa within the nose. MLF will be collected by research staff 
inserting the swab into the participant’s nasal cavity for a period of 60±10 seconds in order to 
obtain the sample. Samples will be processed and stored, in accordance with the instructions 
provided in the study Laboratory Manual, as soon as possible following collection. Samples 
will be shipped to Lumen Bioscience (Seattle, USA) for subsequent processing and analysis 
to determine the levels of drug product in the MLF. With the participant’s approval, de-
identified leftover samples may be stored at Lumen Bioscience indefinitely and used for 
future research studies related to the development of LMN-301. Detailed instructions for the 
collection, processing, storage and shipment of MLF samples for LMN-301 will be described 
in the study Laboratory Manual.  
11.18 Immunogenicity Assessments 
Serum for determination of the presence of anti-LMN-301 antibodies will be collected on 
Days 1 (pre- and post-dose), 2 and 8 for the sentinel cohort and on Days 1 (pre-and post-
dose), 3 or 4, 7 and 14 for the multi-dose cohort. If anti-drug antibodies are confirmed, 
additional testing on the samples may be performed (e.g., titer and neutralizing antibodies) to 
further understand the process. 
Serum samples will be stored at -80°C until shipped to Lumen Bioscience (Seattle, USA) for 
subsequent processing and analysis. With the participant’s approval, de-identified leftover 
samples may be stored at Lumen Bioscience indefinitely and used for future research studies 
related to the development of LMN-301. Detailed instructions for the collection, processing, 
and shipment of samples for immunogenicity analysis will be described in the study 
Laboratory Manual. 
11.19 Blood Sample Volumes 
The following tables contain the approximate blood volumes to be collected per participant 
throughout the study. The final blood volumes required for each sample type will be 
documented in the study Laboratory Manual. 
Additional blood samples may be collected from a participant at any time throughout the 
study, if required for safety reasons. 
Table 11-A  Approximate Blood Sample Volumes Collected Per Participant (Part 1, 
Single Dose) - Individual 
Sample Type 
Approximate Blood Volume 
Per Sample 
Number of Timepoints  
Approximate 
Total Volume 
Haematology 
4 mL 
4 
16 mL 
Serum chemistry 
9 mL 
4 
36 mL 
Coagulation 
3 mL 
4 
12 mL 
Serology 
9 mL 
1 
9 mL 
Serum Pregnancy 
Evaluated from serum chemistry blood sample tube, where 
applicable. 
 
FSH levels 

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Sample Type 
Approximate Blood Volume 
Per Sample 
Number of Timepoints  
Approximate 
Total Volume 
PK 
4 mL 
4 
16 mL 
Immunogenicity 
4 mL 
4 
16 mL 
Canula discard 
2 mL 
4 
8 mL 
Total approximate volume per participant 
113 mL 
Abbreviations: FSH = follicle-stimulating hormone; PK = pharmacokinetics 
Note: volumes are approximate. Final blood volumes will be documented in the study laboratory manual. 
Table 11-B  Approximate Blood Sample Volumes Collected Per Participant (Part 2, 
Multiple Dose) 
Sample Type 
Blood Volume Per Sample 
Number of Timepoints  
Total Volume 
Haematology 
4 mL 
6 
24 mL 
Serum chemistry 
9 mL 
6 
54 mL 
Coagulation 
3 mL 
6 
18 mL 
Serology 
9 mL 
1 
9 mL 
Serum Pregnancy 
Evaluated from serum chemistry blood sample tube, where 
applicable. 
 
FSH levels 
PK 
4 mL 
5 
20 mL 
Immunogenicity 
4 mL 
5 
20 mL 
Canula discard 
2 mL 
5 
10 mL 
Total approximate volume per participant 
155 mL 
Abbreviations: FSH = follicle-stimulating hormone; PK = pharmacokinetics 
Note: volumes are approximate. Final blood volumes will be documented in the study laboratory manual. 
 
 

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12 
ASSESSMENT AND MANAGEMENT OF ADVERSE EVENTS 
12.1 Adverse Event Definitions 
An AE is any untoward medical occurrence in a patient or clinical study participant 
administered a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment.  
An AE can therefore be any unfavourable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) product.  
An SAE is any AE that at any dose: 
• Results in death. 
• Is life-threatening. 
Note: the term ‘life-threatening’ in the definition of ‘serious’ refers to an event in 
which the participant was at risk of death at the time of the event; it does not refer to 
an event which hypothetically might have caused death, if it were more severe). 
• Requires inpatient hospitalisation or prolongation of an existing hospitalisation. 
Note: only hospitalisations that are longer than expected based on Investigator 
judgement, will be considered prolonged hospitalisations. 
• Results in persistent or significant disability/incapacity. 
Note: results in a substantial disruption of a person’s ability to conduct normal life 
functions. 
• Is a congenital anomaly/birth defect. 
Note: a congenital anomaly/birth defect that occurs in the offspring of a participant 
exposed to the IP. 
Medical and scientific judgment should be exercised in deciding whether other situations 
should be considered serious such as important medical events that may not be immediately 
life threatening or result in death or hospitalisation but might jeopardise the participant or 
may require medical or surgical intervention to prevent one of the other outcomes listed in 
the above definition. Examples of such events are intensive treatment in an emergency room 
or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in 
hospitalisation, or development of drug dependency or drug abuse. 
A suspected unexpected serious adverse reaction (SUSAR): An AE that meets all the 
following criteria: 
• Is serious 
• There is a least a reasonable possibility of a causal relationship between the event and 
the investigational product 
• Is considered unexpected (i.e., the event is not listed in the Investigator’s Brochure or 
is not listed at the specificity or severity that has been observed). "Unexpected” as 
used in this definition, also refers to AEs that are mentioned in the Investigator’s 
Brochure as occurring with a class of drugs or are anticipated from the 
pharmacological properties of the drug but are not specifically mentioned as occurring 
with the particular drug under investigation. 
Abnormal laboratory findings (e.g., serum chemistry, haematology, coagulation, and 
urinalysis) or other abnormal assessments (e.g., vital signs, and physical examination 

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findings) that are judged by the PI as clinically significant (CS) will be recorded as AEs or 
SAEs if they meet the definitions stated above. Clinically significant abnormal laboratory 
findings or other abnormal assessments that are detected after the first administration of the 
study drug or are present at baseline and significantly worsen following administration of the 
study drug will be reported as AEs or SAEs. The PI will exercise his/her medical and 
scientific judgement in deciding whether an abnormal laboratory finding, or other abnormal 
assessment, is CS. 
12.2 Evaluating Adverse Events and Serious Adverse Events 
12.2.1 
Assessment of Severity 
The Investigator will make an assessment of severity for each AE and SAE reported during 
the study. The assessment will be based on the Investigator’s clinical judgment. The severity 
of each AE and SAE will be graded using the most current version of the National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5-point scale 
(Table 12-A). 
Table 12-A  NCI-CTCAE 5-point Scale for Grading the Intensity of Each AE and 
SAE 
Grade 
Definition 
I 
Mild  
Asymptomatic or mild symptoms: clinical or diagnostic 
observations only; intervention not indicated. 
II 
Moderate  
Minimal, local, or non-invasive intervention indicated; limiting 
age-appropriate instrumental ADL. 
III 
Severe 
Severe or medically significant but not immediately life-
threatening: hospitalisation or prolongation of hospitalisation 
indicated; disabling; limiting self-care ADL. 
IV 
Life-threatening 
Life-threatening consequences: urgent intervention indicated. 
V 
Death 
Death related to AE. 
Abbreviations: ADL = activities of daily living; AE = adverse event. 
If an AE/SAE has multiple aspects (symptoms), the aspect with the highest severity will be 
graded. 
The term severe is a measure of severity. Thus, a severe AE is not necessarily serious. For 
example, itching for several days may be rated as severe, but may not be clinically serious. 
12.2.2 
Assessment of Causality 
The Investigator will make an assessment as to the relationship between study drug and the 
occurrence of each AE/SAE. The Investigator will use clinical judgment to determine 
whether or not the AE/SAE is causally related to the study drug. Alternative causes, such as 
natural history of any underlying diseases, concomitant therapy, other risk factors, and the 
temporal relationship of the event to the study drug will be considered and investigated. The 
Investigator will also consult the Investigator’s Brochure in the determination of his/her 
assessment. 

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The causal relationship of the study drug to an AE/SAE will be rated according to the 
following 2-point scale Table 12-B. 
Table 12-B  Categories for Assessing Relationship of an Adverse Event to Study 
Drug 
Causal Relationship 
Definition 
Not related 
Temporal association with study drug administration is lacking or other 
causative factors (e.g., participant’s clinical state or environmental 
factors or other therapies administered) more likely explain the event. 
Related 
There is a reasonable temporal association with administration of study 
drug or the event is more likely explained by the investigational product 
than by another cause (i.e., the AE shows a pattern of response 
consistent with previous knowledge of the study drug). 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements, therefore, the Investigator must make an assessment of causality based on all 
available information for every event and prior to transmission of an SAE Form to the 
Sponsor. The Investigator may change his/her opinion regarding causality in light of follow-
up information and amend the SAE Form and the eCRF accordingly. 
12.3 Procedures and Time Period for Detecting Adverse Events 
The Investigator or designee is responsible for detection, recording and reporting of events 
that meet the criteria and definition of AEs.  
As a consistent method of soliciting AEs, the participant shall be asked a nonleading question 
such as: "How do you feel?”. 
The presence or absence following ‘solicited AEs’ will be assessed by direct questioning: 
• stuffy nose  
• runny nose  
• sneezing  
• nasal irritation  
• nasal tenderness/ pain  
• loss of smell  
• sore throat/ scratchy throat  
• cough 
Detection and recording of study related AEs and SAEs extends from the signing of the 
consent form until completion of the last study related procedure (including follow-up for 
safety assessments). Any AE reported or observed at or after the start of dosing with study 
drug will be recorded as a treatment-emergent AE (TEAE) or SAE.  
Any pre-existing conditions or signs and/or symptoms present in a participant prior to the 
start of the study (i.e., before informed consent), should be recorded as medical history. In 
addition, any change in health status that is reported or observed after informed consent but 
prior to starting study drug and is deemed by the study Investigator to be “not related” to 
study procedures, will be documented as medical history.  

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A post-study AE/SAE is defined as any event that occurs outside of the nominal AE/SAE 
study detection period. Investigators are not obligated to actively seek AEs/SAEs in former 
study participants. However, if the Investigator learns of any SAE, including a death, at any 
time after a participant has completed the study and he/she considers the event reasonably 
related to the investigational product, the Investigator will promptly notify the Sponsor.  
Participants must be provided with an “Emergency Wallet Card” indicating the name of the 
investigational product, the study number, the Investigator’s name, a 24-hour emergency 
contact number, and, if applicable, excluded concomitant medications. 
12.4 Recording of Adverse Events and Serious Adverse Events 
All AEs, regardless of seriousness, severity, or presumed relationship to study drug, must be 
recorded in the eCRF using medical terminology in the eCRF and/or other sources. Whenever 
possible, diagnoses should be given when signs and symptoms are due to a common etiology 
(e.g., cough, runny nose, sneezing, sore throat, and head congestion may be reported as 
“upper respiratory infection”). Investigators must record in the eCRF the date of onset of the 
event, their opinion concerning the relationship of the event to study drug, severity of the 
event, whether the event is serious or nonserious, actions taken to manage the event, the 
outcome of the event, and date of resolution where applicable. 
Any change to the severity of an AE must be recorded as a separate AE, ensuring that the end 
date and time of the preceding AE matches the start date and time of the subsequent AE, so 
that the overall duration of the AE is continuous. 
12.5 Reporting of Serious Adverse Events and Suspected Unexpected Serious Adverse 
Reactions 
In accordance with ICH guidelines for GCP, a copy of the written report of any SAEs should 
promptly be sent to the study Sponsor. The Investigator must notify Sponsor and Sponsor’s 
designated study safety officer within 24 hours of becoming aware of the occurrence of an 
SAE.  
Information regarding SAEs will be transmitted to the Sponsor and Sponsor’s designated 
study safety officer using an SAE form as described in the study SAE Report Form 
Completion Guidelines. The SAE form must be completed and signed by a member of the 
investigational staff and transmitted to the Sponsor and Sponsor’s designated study safety 
officer within 24 hours (Table 12-C). New or updated information on the SAE will be 
recorded on a new SAE form and sent to the Sponsor and Sponsor’s designated study safety 
officer within 24 hours of the information being available. The initial and follow-up reports 
of an SAE should be made by e-mail. 
Table 12-C  Contact Details for Transmission of Serious Adverse Event Reporting 
Forms  
Sponsor 
Sponsor Designated Safety Officer 
Name: Lumen Drug Safety 
Email: Safety@lumen.bio 
Name: Avance Safety  
Phone: +61 478 034 138  
Email: safety@avancecro.com 
The Investigator must also report SAEs to the appropriate HREC that approved the protocol 

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according to their requirements. All SAEs will be reported to the HREC within 72 hours of 
the PI becoming aware of the event: 
Bellberry Limited HREC 
123 Glen Osmond Road Eastwood Adelaide 
South Australia 5063 
Phone: (08) 8361 3222 
Email: bellberry@bellberry.com.au 
It is the responsibility of the Sponsor to determine whether a reported SAE fits the 
classification of a SUSAR. The Investigator’s opinion regarding the assessment of 
expectedness (if provided) and causality will be taken into account in the Sponsor’s 
determination of the SAE as a SUSAR. The causality assessment given by the Investigator 
cannot be downgraded by the Sponsor. 
SUSARs will be reported to regulatory authorities in accordance with national requirements. 
The Sponsor assumes responsibility for appropriate reporting of SUSARs to the regulatory 
authorities.  
12.6 Follow-up of Adverse Events and Serious Adverse Events 
After the initial AE/SAE report, the Investigator is required to proactively follow each 
participant and provide further information to the Sponsor on the participant’s condition. 
All AEs and SAEs documented at a previous visit/contact that are designated as ongoing, will 
be reviewed at subsequent visits/contacts. If these have resolved, this should be documented. 
AEs/SAEs that have not resolved by the end of the study, or that have not resolved upon 
discontinuation of the participant’s participation in the study, must be followed until any of 
the following occurs: 
• The event resolves. 
• The event stabilises. 
• The event returns to Baseline, if a Baseline value is available. 
• The event can be attributed to agents other than the study drug or to factors unrelated 
to study conduct. 
• It becomes unlikely that any additional information can be obtained (participant or 
health care practitioner refusal to provide additional information, lost to follow-up 
after demonstration of due diligence with follow-up efforts). 
The Investigator will ensure that AE/SAE follow-up includes any supplemental investigations 
as may be indicated to elucidate the nature and/or causality of the event. This may include 
additional laboratory tests or investigations, histopathological examinations, or consultation 
with other health care professionals. 
The Sponsor may request that the Investigator perform or arrange for the conduct of 
supplemental measurements and/or evaluations to elucidate as fully as possible the nature 
and/or causality of the AE/SAE. If a participant dies during participation in the study or 
during a recognised follow-up period, where possible, the Sponsor will be provided with a 
copy of any post-mortem findings, including histopathology. 

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12.7 Exposure In Utero Management and Reporting 
Dosing of the study drug must be discontinued immediately in instances of pregnancies or 
suspected pregnancies (including a positive pregnancy test regardless of age) in a participant 
that is on investigational product (including the female partner of a male participant).  
The Investigator will notify the Sponsor and designated study safety officer of any pregnancy 
he/she becomes aware of in female participants or the partners of male participants using an 
exposure-in-utero form. The pregnant participant (or the male participant’s pregnant partner) 
should be advised to call her healthcare provider. 
The Investigator shall obtain informed consent from the pregnant participant (or male 
participant’s pregnant partner) in order to the Investigator (or delegate) to conduct follow-up 
throughout the gestational period and on the infant following delivery. The Investigator shall 
follow-up newborn infants that have been exposed to investigational product in utero for a 
minimum of 12 months. Upon discovery of any congenital anomalies (or neonatal deaths) the 
Investigator shall submit a follow-up report to the Sponsor and Sponsor’s designated study 
safety officer using an SAE form including information regarding the status of the newborn. 
A miscarriage or any abortion shall also be reported by the Investigator to the Sponsor and 
Sponsor’s designated study safety officer using an SAE form (as per the study SAE Report 
Form Completion Guidelines). 
 
 

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13 
STATISTICS AND DATA ANALYSIS 
Detailed methodology for the summation and statistical analysis of the data collected will be 
documented in a separate Statistical Analysis Plan (SAP) that will be finalised before 
database lock. Any changes to the methods described in the final SAP will be described and 
justified as needed in the clinical study report (CSR). 
This section describes the general framework to be used for the analysis and presentation of 
data in this study. The information described in this section may be revised during the study 
to accommodate protocol amendments and to make changes to adapt to unexpected issues in 
study execution and data that could affect planned analyses.  
Generally, summaries will be presented separately for Parts A and B, with summaries 
presented by treatment group and overall for Part B. 
For descriptive statistics, continuous data will be summarised by treatment arm and time 
point using the number of observations, arithmetic mean, standard deviation (SD), median, 
minimum and maximum. Discrete data will be summarised using counts and percentages. 
All available data will be included in data listings. Data tabulations will be performed for 
specific analysis populations. 
13.1 Sample Size Considerations 
The total study sample size was selected to have a high probability of detecting one or more 
serious adverse events (SAE) if the SAE event rate is 10% or more.  If the probability of an 
SAE is 10%, the probability of observing at least one event in N=35 subjects is over 97%.  
Looking at Part B only, if the probability of an SAE is 10%, the probability of observing at 
least one event in N=30 subjects is over 95%.   
13.2 Analysis Populations 
Full Analysis Set 
The Full Analysis Set will include all enrolled participants.  
Safety Analysis Set 
All participants who receive any study drug will be included in the Safety Analysis Set and 
will be analysed as per the actual treatment received, if this differs from that to which the 
participant was randomised. 
Pharmacokinetic Analysis Set 
The PK Analysis Set will include all participants in the Safety Analysis Set who have at least 
one study drug concentration determined.    
Immunogenicity Analysis Set 
The Immunogenicity Analysis Set will include all participants in the Safety Analysis Set who 
have sufficient data to derive at least one Immunogenicity parameter. 
13.3 Disposition 
The number of participants enrolled in the study, screen failed participants (if available), 
participants who completed the study, patients who prematurely withdrew from the study 

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(including reasons for withdrawal) and the number of patients in each analysis set will be 
summarized. 
13.4 Demographic and Baseline Data 
Demographic and baseline data will be presented using the safety analysis set. 
Demographic data (including gender, age, race, ethnicity, height, weight, and BMI) will be 
summarised using descriptive statistics. 
Medical history will be coded using the latest version of the Medical Dictionary for 
Regulatory Activities (MedDRA). The number of participants reported with 
conditions/procedures and the number of conditions/procedures reported will be summarised, 
grouped according to system organ class (SOC) and preferred term, using descriptive 
statistics. 
Assessments performed for eligibility only will be listed. 
13.5 Prior and Concomitant Medication Data 
Prior and concomitant medication data will be presented using the safety analysis set. 
Prior and concomitant medications will be coded using the latest version of the World Health 
Organisation Drug Dictionary (WHO DD). The number and percentage of participants taking 
prior medication, and concomitant medication will be summarised using frequency tables 
according to WHO Drug Anatomical Therapeutic Chemical (ATC) Classification Level 1 
Code Description and the WHO DD Preferred Name. If a participant has more than one prior 
or concomitant medication coded to the same preferred name, the participant will be counted 
only once in the summaries. 
13.6 Treatment Compliance and Exposure Data 
Treatment compliance and exposure data will be presented using the safety analysis set and 
full analysis set. 
Treatment exposure and compliance will be summarised using descriptive statistics and 
presented by treatment group and overall. 
13.7 Safety and Tolerability Data 
All safety analysis will be performed using the safety analysis set. 
13.7.1 
Adverse Event Data 
All AEs will be coded using the latest version of MedDRA by SOC and preferred term, 
classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as 
the number and percentage of participants with at least one TEAE, will be summarised by 
SOC and preferred term. Summaries of TEAEs by severity and relationship will also be 
presented. Summaries will also be presented for SAEs, TEAEs leading to death or study 
withdrawal. The duration of all AEs will be determined and included in the listings. 
Solicited and unsolicited TEAEs will also be summarised separately. Further details will be 
provided in the SAP. 

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13.7.2 
Vital Signs 
Observed values and changes from baseline for vital signs (systolic and diastolic blood 
pressure, pulse rate, oral temperature, and respiratory rate) will be summarised at each 
scheduled timepoint using descriptive statistics. 
13.7.3 
Nasal Examinations 
Nasal examination findings will be listed. Any post-dose clinically significant findings will 
be reported as AEs. 
13.7.4 
Physical Examination Data 
Physical examination data will be listed only. Any post-dose clinically significant findings 
will be reported as AEs. 
13.7.5 
Clinical Laboratory Safety Data 
Clinical laboratory safety data will be summarised by laboratory parameter. Observed values 
and changes from baseline for continuous clinical laboratory parameters will be summarised 
at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data 
will be summarised at each scheduled timepoint using participant counts and percentages. 
The clinical assessment of laboratory data will be summarised at each scheduled timepoint 
using participant counts and percentages. Individual participant profiles will be presented for 
any laboratory parameters with at least one post-dose value outside the laboratory’s reference 
ranges that is deemed clinically significant. 
13.7.6 
Electrocardiogram 
For ECG data, replicate values will be averaged to determine the value of the ECG parameter 
at each timepoint. 
The following ECG parameters will be analysed: PR interval, QRS duration, QTcB, QTcF 
and ventricular heart rate. Observed values and changes from baseline for ECG parameters 
will be summarised at each scheduled timepoint using descriptive statistics. 
For QTcF, the number of participants with values greater than 450 (and 480, 500) msec or an 
increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with 
ICH E14 (Note for guidance on the clinical evaluation of QT/QTc interval prolongation and 
proarrhythmic potential for non-antiarrhythmic drugs, CHMP/ICH/2/04). 
13.7.7 
Nasal Symptoms Sino-Nasal Outcome Test 
Scores will be totalled for all 22 symptoms. Changes from baseline in individual total SNOT-
22 scores will be calculated as the post-baseline value minus the baseline value. Thus, a 
negative change will reflect an improvement in the corresponding score. Observed values and 
changes from baseline will be summarised at each scheduled timepoint by treatment using 
descriptive statistics and tabulated for each cohort (dose level) and overall. 
Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT 
score will also be included in the listing. 

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13.8 Pharmacokinetic Data 
All PK analysis will be conducted using PK Analysis Set. Participants with dosing deviations 
that could potentially affect the PK profile may be excluded from the PK parameter 
evaluation, at the discretion of the study pharmacokineticist.   
Individual participant LMN-301 plasma and nasal mucosal lining fluid concentrations will be 
listed and summarised using descriptive statistics (n, mean, standard deviation, coefficient of 
variation [%CV], minimum, maximum, median, geometric mean and geometric coefficient of 
variation). Individual and mean LMN-301 plasma concentrations over time will be presented 
graphically with concentration displayed on a linear and a logarithmic scale for each dose 
group using nominal time points. 
Summaries (frequency, means, etc.) will be generated and presented in tabular and/or 
graphical form.   
Due to the sparseness of the PK sampling scheme, no PK parameters will be determined. 
Serum and nasal drug concentrations be determined at the timepoints presented in Table 21-C 
and Table 21-D, and will be presented in tabular or graphical form, as appropriate. 
If the overall test for group differences is significant, pairwise comparisons between groups 
will be generated adjusting for multiple comparisons.  Additional details will be presented in 
the SAP.    
13.9 Immunogenicity Data 
Immunogenicity data will be analysed using the Immunogenicity Analysis Set.  
For Part A, serum anti-LMN-301 antibody (possibly binary yes/no, titer, neutralizing) on Day 
1 (predose), Day 1 (postdose) and Day 8 will be reported for each subject and presented in 
tabular or graphical form. 
For Part B, serum anti-LMN-301 antibody (possibly binary yes/no, titer, neutralizing) on Day 
1 (predose), Day 1 (post dose), Day 3 or 4 (predose), Day 7 (predose) and Day 14 will be 
reported for each subject and presented in tabular and/or graphical form.   
Summaries (frequency, means, etc.) will be generated and presented in tabular and/or 
graphical form.   
If the overall test for group differences is significant, pairwise comparisons between groups 
will be generated adjusting for multiple comparisons.  Additional details will be presented in 
the SAP.    
13.10 Interim Analysis 
No interim analyses are currently planned. 
14 
DATA HANDLING AND RECORD KEEPING 
14.1 Privacy of Personal Data 
To maintain participant privacy, all eCRFs, study drug accountability records, study reports 
and communications will identify the participants only by their assigned study number. The 
PI will grant monitor(s) and auditor(s) designated by the global or local sponsor or regulatory 
authorities’ access to the participant’s original medical records for verification of data 

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recorded in the eCRF and for the purposes of auditing the data collection process. The 
participant’s confidentiality will be maintained at all times and will not be made publicly 
available to the extent permitted by the applicable laws and regulations. 
14.2 Screening/Enrolment Logs and Privacy 
The PI is required to complete a participant enrolment log to permit reference to each 
participant during and after the study. Any log identifying study participant identity will be 
treated as confidential and will be filed by the PI in the Investigator Site File. This document 
will be reviewed by the study monitor for completeness. To ensure participant confidentiality, 
if such log is required to be distributed to the Sponsor, it must first have any personal details 
(e.g., name, initials, date of birth) redacted. 
The PI must also complete a screening log, which reports on all participants who were 
assessed to determine eligibility for inclusion in the study. 
14.3 Source Documentation 
Source documentation must be prepared and available to capture at a minimum the following 
aspects and parameters: 
• Adherence to protocol procedures 
• Participant identification, eligibility, and participation 
• Informed consent procedures 
• Protocol specified assessments 
• Dates of visits 
• Safety parameters including reporting and follow-up of AEs and use of concomitant 
medication 
• PK parameters 
• Immunogenicity parameters 
• Study drug receipt/dispensing/return records 
• Study drug administration information 
• Date of participant completion 
• Discontinuation from treatment, or withdrawal from the study, and the reason if 
appropriate 
Specific items required as source documents will be reviewed with the PI before the study. 
The author of an entry in the source documents must be identifiable. Worksheets may be used 
for the capture of some data to facilitate completion of the eCRF. Any such worksheets will 
become part of the participants’ source documentation. 
Following the ICH GCP guidelines, direct access to source documentation and medical 
records must be allowed for the purpose of verifying that the data recorded in the eCRF are 
consistent with the original source data. 
14.4 Electronic Case Report Form 
An eCRF entry must be completed for each participant who is enrolled and receives at least 
one dose of study drug. For reasons of confidentiality, the name and initials of the participant 
should not appear in the eCRF. All eCRF entries, corrections, and alterations must be made 
by the PI or other authorized study site personnel. 

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Data entry into the eCRF will be performed throughout study conduct according to the 
Sponsor’s (or delegate) instructions and reviewed by the Sponsor (or delegate) to determine 
their acceptability. If necessary, eCRF queries will be raised by the Sponsor (or delegate) 
relating to eCRF data entries. The PI or authorized study site staff must address all eCRF 
queries raised. 
14.5 Recordkeeping and Retention of Records 
In compliance with the ICH/GCP guidelines, the PI/institution will maintain all source 
documents that support the data collected from each participant, as well as all study 
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a 
Clinical Trial. The PI/institution will take measures to prevent accidental or premature 
destruction of these documents. 
Following closure of the study, the PI must maintain all site study records in a safe and secure 
location. The records must be maintained to allow easy and timely retrieval, when needed 
(eg, audit or inspection) and whenever feasible, to allow any subsequent review of data in 
conjunction with assessment of the facility, supporting systems and staff. When permitted by 
local laws/regulations or institutional policy, some or all of these records can be maintained 
in a format other than hard copy (eg, microfiche, scanned, electronic); however, caution 
needs to be exercised before such action is taken. The PI must assure that all reproductions 
are legible and are a true and accurate copy of the original and meet accessibility and retrieval 
standards, including regenerating a hard copy, if required. Furthermore, the PI must ensure 
there is an acceptable back-up of these reproductions and that an acceptable quality control 
process exists for making these reproductions. 
The Sponsor will inform the PI of the time period for retaining these records to comply with 
all applicable regulatory requirements. The minimum retention time will meet the strictest 
standard applicable to that site for the study, as dictated by any institutional requirements or 
local laws or regulations, or Sponsor’s standards/procedures; otherwise, the retention period 
will default to 15 years. 
If the responsible PI retires, relocates, or for other reasons withdraws from the responsibility 
of keeping the study records, custody must be transferred to a person who will accept the 
responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. 
Under no circumstance shall the PI relocate or dispose of any study documents before having 
obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the PI must permit access to all study documentation. 
The material to be stored shall include, but is not limited to, the following:  
• Signed and dated copy of the HREC approved protocol and any HREC approved 
protocol amendments; 
• Signed and dated letter of HREC approval, letter of constitution of the HREC and 
copies of any other correspondence relevant to the study with the HREC or regulatory 
authorities; 
• The HREC approved original and amended ICFs; 
• Current curriculum vitae (signed and dated) of the PI and co-workers with major 

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responsibilities in the trial; 
• Site Signature and Delegation of Responsibility Log; 
• Financial Disclosure Form(s); 
• Blank copy of the study eCRF; 
• Signed ICFs; 
• Laboratory reference ranges (signed and dated); 
• The final clinical study report; 
Clinical raw data including the source data forms, all clinical laboratory report forms, 
participant eCRFs, drug accountability forms, and dispensing records. 
 
 

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15 
ETHICS AND REGULATORY COMPLIANCE 
15.1 Investigator Responsibilities 
The PI must conduct the clinical study in accordance with the HREC approved study 
protocol, current ICH guidelines for GCP, and applicable regulatory and legal requirements. 
Good clinical practice is an international ethical and scientific quality standard for designing, 
conducting, recording, and reporting studies that involve the participation of human subjects. 
Compliance with this standard provides public assurance that the rights, safety, and wellbeing 
of study participants are protected, consistent with the principles that originated in the 
Declaration of Helsinki, and that the clinical study data are credible. 
15.2 Regulatory Notification 
The requirements for the conduct of clinical trials in accordance with the applicable 
regulations for each country must be met before commencement of this study. 
15.3 Ethical Considerations 
This study will be carried out according to the principles of the Declaration of Helsinki, the 
ICH guidelines for GCP (as adopted in each country/region) and any local guidelines or 
regulations. 
Conduct of the study must be approved by an appropriately constituted HREC before 
participants are enrolled. Prior to initiation of the study, written HREC approval of the 
protocol and ICFs, based on the principles of ICH GCP, will be received. This approval will 
refer to the ICFs and to the study protocol by title and protocol number and will also include 
date of each document. 
A copy of the signed and dated letter of approval will be sent to the study monitor and 
sponsor prior to study commencement. Any written information and/or advertisements to be 
used for volunteer recruitment will be approved by the HREC prior to use. A list of the 
HREC voting members, their titles or occupations, and their institutional affiliations will also 
be provided to the study monitor and Sponsor before study initiation; or a statement provided 
that the constitution meets applicable requirements. If approval is suspended or terminated by 
the HREC, the PI will notify the sponsor immediately. 
Protocol amendments that may impact on participant safety or the validity of the study will 
be approved by HREC, following written agreement for the amendment from the Sponsor. 
The amended protocol will not be implemented at sites until such approvals are received 
other than in the case of an urgent safety measure. 
An accurate and complete record of all submissions made to the HREC must be maintained 
in line with local regulations. The records should be filed in the Investigator Site File and 
copies must be sent to the Sponsor and maintained in the study Trial Master File. 
The Sponsor agrees to abide by the relevant local and/or national guidelines for compensation 
for injury resulting from participating in a company sponsored research project. 
Compensation will only be provided on the understanding that the provision of compensation 
does not amount to an admission of legal liability and is participant to the proposed recipient 
signing a full and complete release of the company from all claims, damages and costs. 

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15.4 Informed Consent 
Informed consent will be obtained before any volunteer can participate in the study. The ICF 
will be prepared by the sponsor. The ICF will clearly describe the nature, scope, and potential 
risks and benefits of the study, in a language that the participant understands. The ICF must 
also be signed and dated by the person who conducted the informed consent procedure and 
the participant before the conduct of any study-related activity. The contents and process of 
obtaining informed consent will be in accordance with all applicable regulatory requirements 
and adhere to ICH GCP and US FDA guidelines (21 CFR 50) and the requirements in the 
Declaration of Helsinki. Study participation includes any and all screening and training 
procedures, as well as any washout of excluded medications. 
It is the responsibility of the PI (or the delegate who conducted the informed consent 
procedure) to obtain a voluntary signed and dated ICF from each individual participating in 
this study after adequate explanation of the aims, methods, objectives, and potential hazards 
of participating in the study. The PI (or delegate) must also explain to the participants that 
they are completely free to refuse to enter the study or to withdraw from it at any time 
without prejudice. All eligible participants must receive a full explanation, in layperson’s 
terms, of the aims of the study, the discomfort, risks and potential benefits in taking part as 
well as of insurance and other procedures for compensation in case of injury. It will be 
explained that the study is for research purposes only and is not expected to provide any 
therapeutic benefit to the individual. Each participant will acknowledge receipt of this 
information by giving written informed consent for participation in the study. All participants 
will be given a copy of the signed ICF to retain. 
Should a protocol amendment become necessary, the ICF may need to be revised to reflect 
the changes to the protocol. It is the responsibility of the Sponsor (or delegate) to ensure that 
an amended ICF is reviewed and has received favourable opinion from the HREC, and the PI 
has to ensure that the amended ICF is signed by all participants subsequently entered in the 
trial and those currently in the trial, if affected by the amendment. 
15.5 Emergency Contact with Principal Investigator 
Suitable arrangements must be made for participants to contact the PI or medically trained 
nominee in the event of an emergency. 
15.6 Clinical Laboratory Certification and Reference Ranges 
Before the initiation of this study, the PI, or nominee, will obtain a copy of the certification 
form, with certification number and expiration date for all clinical laboratories used in the 
study by their site. Reference ranges for each clinical laboratory test used in this study will be 
obtained from the laboratory that will perform the test during the study. 
15.7 Study Completion/Site Closure 
The study is considered completed at the last contact of the last participant involved in the 
study. The final data from the investigational site will be sent to the Sponsor (or designee) in 
the time frame specified in the Clinical Trial Agreement. Investigational sites will be closed 
upon study completion. An investigational site is considered closed when all required 
documents and study supplies have been collected and a site closure visit has been performed 
by the sponsor (or delegate). 

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15.8 End of Study and Regulatory Notification 
At the end of the study, the HREC and relevant regulatory authorities will be notified by the 
Sponsor (or delegate) according to applicable HREC and regulatory requirements. 
 
 

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16 
QUALITY CONTROL AND ASSURANCE 
16.1 Study Monitoring 
In Australia, the local Sponsor is responsible for assuring the proper conduct of the study 
regarding protocol adherence and validity of the data recorded in the eCRF. In accordance 
with applicable regulations and ICH GCP, Avance Clinical will act as the local Sponsor of 
this study and will be responsible for the assignment of a study monitor who will (on-site or 
remotely) perform source data verification, monitor drug accountability, ensure that the eCRF 
is completed correctly and that the protocol is being adhered to.  
During the course of the trial, the study monitor will visit the trial site and/or perform remote 
monitoring at regular intervals. The extent, nature and frequency of on-site visits will be 
based on such considerations as the study objectives and/or endpoints, the purpose of the 
study, study design complexity, and enrolment rate. 
The PI must make themselves available to the Sponsor study monitor during an on-site (or 
remote) monitoring visit to enable discussion on any arising issues relating to the study. 
The PI agrees to allow the study monitor direct access to relevant source documents (original 
documents, data, and records). Direct access includes permission to examine, analyse, verify, 
and reproduce any record(s) and report(s) that are important for the evaluation of the clinical 
trial conduct. The PI also agrees to allocate his/her time and the time of his/her staff to the 
study monitor to discuss findings and any relevant issues. 
Participant confidentiality must be maintained during any monitoring activities conducted by 
the local sponsor or its delegate(s). 
During an on- site (or remote) visit, the study monitor will: 
• Check the progress of the study. 
• Review study data collected. 
• Conduct source data verification. 
• Identify any issues and address their resolution. 
• Check study treatment accountability records. 
• Review biological samples collected for the study and ensure that they are labelled 
and stored correctly. 
• Verify that: 
o The data are authentic, accurate and complete. 
o Safety and rights of participants are being protected. 
o Study is conducted in accordance with the currently approved protocol (and 
any amendments), ICH GCP and all applicable regulatory requirements. 
At study closure, the study monitor will conduct the following activities in conjunction with 
the PI or site staff as appropriate: 
• Ensure that all data queries have been resolved. 
• Conduct final accountability and reconciliation for study treatment supplies including 
inventory and final disposition (e.g., destruction, shipping to repository, etc.). 
• Review of site study records for completeness. 

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16.2 Quality Assurance and Quality Control 
To ensure compliance with ICH GCP and all applicable regulatory requirements, the Sponsor 
(or a designated third party), may conduct a quality assurance audit of the study site. 
Regulatory agencies may also conduct a regulatory inspection of this study. Such 
audits/inspections can occur at any time during or after completion of the study. If an audit or 
inspection occurs, the PI and Institution agree to notify the Sponsor as soon as possible 
following awareness of an impending regulatory inspection. The PI and Institution agree to 
allow the auditor/inspector direct access to all relevant documents and allocate his/her time 
and the time of his/her staff to the auditor/inspector to discuss findings and any relevant 
issues. 
The Sponsor (or its designee) will perform the quality assurance and quality control activities 
for this study; however, responsibility for the accuracy, completeness, and reliability of the 
study data presented to the sponsor lies with the PI (and delegate(s)) generating the data. 
Prior to the study initiation, the sponsor (or its designee) will explain the protocol, IB, and 
eCRF to the PI and the site staff involved in this study. In addition, the assigned study 
monitor will be available to explain applicable regulations and to answer any questions 
regarding the conduct of the study. 
16.3 Data Quality Control 
Steps to be taken to ensure the accuracy and reliability of data include the selection of 
qualified Investigators and appropriate study centres, review of protocol procedures with the 
PI and associated personnel before the study and conduct of periodic monitoring visits by the 
sponsor (or designee). Written instructions will be provided for collection, preparation, and 
shipment of biological samples collected for the purposes of this study. Electronic CRF 
completion training will be conducted with study personnel before the start of the study. The 
study monitor will review electronic data for accuracy and completeness during on-site (or 
remote) monitoring visits and any discrepancies will be resolved with the PI or designee, as 
appropriate. The data will be entered into the clinical study eCRF and verified for accuracy. 
 
 

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17 
FINANCING AND INSURANCE 
Financial aspects of the study are addressed in a separate clinical study agreement. 
The PI is required to have adequate current insurance to cover claims for negligence and/or 
malpractice. 
The global Sponsor will provide insurance coverage for the clinical study as required by 
national regulations. The local Sponsor will be subscribed to an insurance policy covering, in 
its terms and provisions, its legal liability for injuries caused to participating persons and 
arising out of this research performed strictly in accordance with the study protocol as well as 
with applicable law and professional standards prior to commencement of the study. 
 
 

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18 
PROTOCOL GUIDELINES 
18.1 Protocol Deviations  
No deviations to the protocol are permitted, except in instances when an emergency occurs 
that requires a departure from the protocol for an individual. The nature and reasons for the 
protocol deviation will be recorded in the Clinical Trial Management System and reported at 
the end of the study in the CSR. Should a non-anticipated protocol deviation occur, the 
sponsor must be informed as soon as possible. 
A minor protocol deviation is an accidental or unintentional change to, or noncompliance 
with the HREC approved protocol that does not increase risk or decrease benefit; does not 
have a significant effect on the participant’s rights, safety or welfare; and/or on the integrity 
of the data. 
A major protocol deviation is an accidental or unintentional change to, or noncompliance 
with the HREC approved protocol, which increases risk or decreases benefit, affects the 
participant’s rights, safety, or welfare, or the integrity of the data. Should a major protocol 
deviation occur, the Sponsor must be informed as soon as possible. Reporting of major 
protocol deviations to the HREC will be in accordance with applicable regulatory authority 
mandates. 
All deviations, and the reasons for the deviation, will be documented by the PI or designated 
staff. 
18.2 Protocol Waivers 
Protocol waivers will not be granted by the Sponsor in this study. 
18.3 Protocol Amendments 
Protocol revisions of typographical errors, clarifications of confusing wording, and other 
minor modifications including but not limited to name, address, and contact information 
changes that have no impact on the safety of the participant, or the science of the study will 
be classed as administrative amendments. Administrative amendments will be submitted to 
the HREC for information only. The local Sponsor (or designee) will ensure that HREC 
acknowledgment of administrative changes to the protocol is received and filed. 
In all other instances, an amendment to the protocol will be classed as a substantial 
amendment and will be submitted to the HREC for approval and the appropriate regulatory 
authorities, as applicable. Any substantial amendment to the protocol will be implemented in 
the conduct of the trial only after approval has been received from HREC. 
 
 

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19 
INTELLECUTAL PROPERTY, CONFIDENTIALITY AND PUBLICATIONS 
19.1 Ownership 
All information provided by the global sponsor and all data and information generated by the 
clinical facility staff as part of the study (other than a participant’s medical records), are the 
sole property of the study Sponsor. 
All rights, title and interests in any inventions, know-how or other intellectual or industrial 
property rights which are conceived or reduced to practice by the PI and the clinical facility 
staff during the course of or as a result of this study are the sole property of the study 
Sponsor. 
Ownership provisions described in this protocol will be superseded by any such provisions 
included in a legal, written contract between the global sponsor and any stakeholder parties 
involved in the conduct of this study. 
19.2 Confidentiality 
All information provided by the sponsor and all data and information generated by the 
clinical facility as part of this clinical study will be kept confidential by the PI and other site 
staff. The PI or other site personnel will not use this information and data for any purpose 
other than conducting the study. These restrictions do not apply to: 
• Information which becomes publicly available through no fault of the PI or site staff. 
• Information which it is necessary to disclose in confidence to an HREC solely for 
the evaluation of the study. 
• Information which it is necessary to disclose in order to provide appropriate medical 
care to a study participant, or 
• Study results which may be published as described in the Publication Policy (Section 
19.3). 
Confidentiality provisions described in this protocol will be superseded by any such 
provisions included in a legal, written contract between the global sponsor and any 
stakeholder parties involved in the conduct of this study. 
19.3 Publication Policy 
The Sponsor may publish the results of this study at appropriate times. No publication of the 
results shall take place without the express consent of the global Sponsor. Publication of the 
trial results includes but is not limited to conference presentations, scientific conference 
abstracts or posters, scientific manuscripts, instructional materials or any such public 
disclosures of the study results generated by the clinical site. 
Participant confidentiality shall be maintained and must not be disclosed in any proposed 
publication materials. 
 
 

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20 
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Dis J, 13(4), 328-330. https://doi.org/10.1097/00006454-199404000-00018 
Sarker, S. A., Jäkel, M., Sultana, S., Alam, N. H., Bardhan, P. K., Chisti, M. J., Salam, M. A., 
Theis, W., Hammarström, L., & Frenken, L. G. J. (2013). Anti-Rotavirus Protein Reduces 
Stool Output in Infants With Diarrhea: A Randomized Placebo-Controlled Trial. 
Gastroenterology, 145(4), 740-748.e8. https://doi.org/10.1053/j.gastro.2013.06.053  
Scott, G. M., Wallace, J., Greiner, J., Phillpotts, R. J., Gauci, C. L., & Tyrrell, D. a. J. (1982). 
Prevention of rhinovirus colds by human interferon alpha-2 from escherichia coli. The 
Lancet, 320(8291), 186–188. https://doi.org/10.1016/S0140-6736(82)91031-5 
Song, R., Zeng, G., Yu, J., Meng, X., Chen, X., Li, J., Xie, X., Lian, X., Zhang, Z., Cao, Y., 
Yin, W., & Jin, R. (2023). Post-Exposure Prophylaxis with SA58 (anti-COVID-19 
monoclonal antibody) Nasal Spray for the prevention of symptomatic Coronavirus Disease 
2019 in healthy adult workers: A randomized, single-blind, placebo-controlled clinical study 
(p. 2022.12.28.22283666). medRxiv. https://doi.org/10.1101/2022.12.28.22283666. 
Sungnak W, Huang N, Bécavin C, Berg M, Queen R, Litvinukova M, Talavera-López C, 
Maatz H, Reichart D, Sampaziotis F, Worlock KB, Yoshida M, Barnes JL; HCA Lung 
Biological Network. SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells 
together with innate immune genes. Nat Med. 2020 May;26(5):681-687. 
https://doi.org/10.1038/s41591-020-0868-6  
Tran, D. M., Tran, T. T., Phung, T. T. B., Bui, H. T., Nguyen, P. T. T., Vu, T. T., Ngo, N. T. 
P., Nguyen, M. T., Nguyen, A. H., & Nguyen, A. T. V. (2022). Nasal-spraying Bacillus 
spores as an effective symptomatic treatment for children with acute respiratory syncytial 
virus infection. Scientific Reports, 12(1), 12402. https://doi.org/10.1038/s41598-022-16136-z  
Weltzin, R., & Monath, T. P. (1999). Intranasal antibody prophylaxis for protection against 
viral disease. Clinical microbiology reviews, 12(3), 383–393. 
https://doi.org/10.1128/CMR.12.3.383  
Zhao, H., Tasch, M., Dodds, M., Gewe, M., Martinez, A., Hutton, M., Keeney, K., Pollock, 
A., Jester, B., Khuong, N., Zhang, M., Brady, C., Heinnickel, M., Tabakh, H., Sanjaya, N., 

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Cruickshank, K., Paddock, T., Ertel, S., Struyvenberg, S., . . . Roberts, J. M. (2022). Using 
antibody synergy to engineer a high potency biologic cocktail against C. difficile. bioRxiv, 
2021.2012.2021.473715. https://www.biorxiv.org/content/10.1101/2021.12.21.473715v3.full  
 
 

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21 
APPENDICES 
This page is intentionally blank. 
 

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21.1 Appendix 1. Schedule of Assessments 
21.1.1 
Part A (Single Dose) 
Table 21-A  Schedule of Assessments for Part A Sentinel Cohort (Open-label, single dose) 
Please note: the schedule of assessments for Part A appears across 3 pages. 
Study Period 
Screening 
Treatment 
Follow-up 
EoS 
 
(-28 to 0) 
Week 1 
Week 2 
Day 1 
Day 2 
Day 3-7 
Day 8 
Days 9-13 
Day 14 
Visit Window (days) 
 
 
 
 
±1 
 
±1 
Informed Consent 
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
 
 
 
 
 
Confinement 
 
X 
X 
 
 
 
 
Outpatient visits 
X 
 
 
 
X 
 
X 
Demographics (age, race, sex, ethnicity) 
X 
 
 
 
 
 
 
Medical/Surgical History, Comorbidities 
X 
X16 
 
 
 
 
 
Prior and concomitant medications 
X 
X 
X 
X 
X 
X 
X 
Screening Physical Examination11 
X 
 
 
 
 
 
 
Targeted Physical Examination11 
 
X 
X 
 
X 
 
X 
Nasal Examination11 
 
X 
 
 
 
 
 
Height, Weight, BMI 
X 
 
 
 
 
 
 
Vital Signs1 
X 
X 
X 
 
X 
 
X 

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Study Period 
Screening 
Treatment 
Follow-up 
EoS 
 
(-28 to 0) 
Week 1 
Week 2 
Day 1 
Day 2 
Day 3-7 
Day 8 
Days 9-13 
Day 14 
Visit Window (days) 
 
 
 
 
±1 
 
±1 
ECG10 
X 
 
 
 
 
 
X 
Serum pregnancy test (WOCBP only) 
X 
 
 
 
 
 
 
Covid-19 Rapid Antigen Test12 
X 
X 
 
 
 
 
 
Urine collection for urinalysis10 
X 
 
 
 
 
 
X 
Urine pregnancy test (WOCBP only)13 
 
X 
 
 
 
 
X 
Urine tox screen2 
X 
X 
 
 
 
 
 
Alcohol Breath Test 
X 
X 
 
 
 
 
 
FSH (post-menopausal women only) 
X 
 
 
 
 
 
 
Viral serology (HIV antibody, HBsAg, HCV) 
X 
 
 
 
 
 
 
Clinical Safety Laboratory samples (hematology 
serum chemistry, coagulation)10 
X 
X 
X 
 
X 
 
X 
Collect serum for study drug detection3 
 
X 
X 
 
X 
 
 
Collect serum for anti-drug antibodies4 
 
X 
X 
 
X 
 
 
Collect nasal secretion sample5 
 
X 
X 
 
X 
 
 
Administer study drug by intranasal delivery 
(single dose) 
 
X 
 
 
 
 
 
Solicited AEs6,7 
 
X 
X 
X 
X 
X 
X 

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Study Period 
Screening 
Treatment 
Follow-up 
EoS 
 
(-28 to 0) 
Week 1 
Week 2 
Day 1 
Day 2 
Day 3-7 
Day 8 
Days 9-13 
Day 14 
Visit Window (days) 
 
 
 
 
±1 
 
±1 
Unsolicited AEs/SAEs6 
 
X 
X 
X 
X 
X 
X 
Review diary 15 
 
 
X 
 
X 
 
X 
Sino-Nasal Outcome Test (SNOT-22)8 
X 
X 
 
 
X 
 
 
Telephone follow-up9 
 
 
 
X9 
 
 
 
Abbreviations: AE=adverse event; BMI=Body mass index; ECG=Electrocardiogram; EoS=End of study; FSH=Follicle stimulating hormone; HBsAg=Hepatitis B surface antigen; 
HCV=Hepatitis C virus; HIV=Human immunodeficiency virus; RAT=Rapid Antigen Test; SAE=serious adverse event; WOCBP = women of childbearing potential. 
1. 
Vital signs to be measured at pre-dose, and 30 min, 1 hr and 4 hr post-dose on Day 1 
2. 
Urine toxicology screen for drugs of abuse. Urine tox screen and alcohol breath test to be performed at any time predose on Day 1. 
3. 
Serum for detection of study drug will be collected before and 2 hours (±15 mins) after dosing on Day 1, and prior to discharge on Day 2, and during clinic visit on Day 8 
4. 
Serum for anti-drug antibodies will be collected pre-dose and 2 hours (±15 mins) on Day 1, prior to discharge on Day 2 and during clinic visit on Day 8 
5. 
Intranasal mucosal lining fluid (MLF) samples will be collected before and 2 hours (±15 mins) after dosing on Day 1, and once prior to discharge on Day 2, and during clinic visit on 
Day 8 
6. 
Participants will be provided with a diary to record any solicited and/or unsolicited AEs, and to record concomitant medication usage. Participants will be instructed by site staff on 
completion during in-person visits 
7. 
Solicited local AEs: stuffy nose, runny nose, sneezing, nasal irritation, nasal tenderness/pain, loss of smell, sore throat scratchy throat, cough 
8. 
Sino-Nasal Outcome Test should be completed at Screening, at 2 hours (±15 mins) post-dose on Day 1, and during clinic visit on Day 8. 
9. 
Research staff to perform daily telephone calls to participants from Days 3-7.  
10. Urinalysis and 12-lead ECG to be performed at Screening and at End of Study. Hematology, serum chemistry and coagulation on Day 1 to be performed any time pre-dose. 
11. Targeted physical examination to be performed within 1 hour pre-dose. Nasal examination to assess swelling of the mucosa, erythema, and secretions to be performed using nasal 
speculum and headlight within 1 hour pre-dose and 3 hours post-dose on Day 1. 
12. Covid-19 RAT test to be performed at screening and prior to dosing on Day 1. Participants testing positive will not be allowed to participate in the study. 
13. Urine pregnancy test to be performed any time prior to dose administration. 
14. Clinical Safety Laboratory samples will be collected at 2 hours (±15 mins) pre-dose on Day 1. 
15. Site staff to review diary as indicated at each clinic visit. Diary to be collected at the final EoS visit on Day 14. 
16. Update only 
 
 

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21.1.2 
Part B (Multiple Dose) 
Table 21-B  Schedule of Assessments for Part B Multi-Dose Cohort (Open-label, multi-dose) 
Please note: the schedule of assessments for Part B appears across 4 pages. 
Study Period 
Screening 
Treatment 
EoS 
 
 (-28 to 0) 
Day 1 
Day 
2 
Day 
3 
Day 
4 
Day 
5 
Day 
6 
Day 
7 
Day 
8 
Day 
9 
Day 
10 
Day 
11 
Day 
12 
Day 
13 
Day 
14 
Day 
28 
Visit Window (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
±2 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient visit: Group 1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
X 
Outpatient visit: Group 2 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
X 
X 
Outpatient visit: Group 3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Demographics (age, race, sex, ethnicity) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/surgical history, comorbidities 
X 
X18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Screening Physical Examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted Physical examination: Group 
112 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
Targeted Physical examination: Groups 
2 and 312 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
X 
 
Nasal Examination: Group 112 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
Nasal Examination: Groups 2 and 312 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
X 
 
Height, Weight, BMI 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Period 
Screening 
Treatment 
EoS 
 
 (-28 to 0) 
Day 1 
Day 
2 
Day 
3 
Day 
4 
Day 
5 
Day 
6 
Day 
7 
Day 
8 
Day 
9 
Day 
10 
Day 
11 
Day 
12 
Day 
13 
Day 
14 
Day 
28 
Visit Window (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
±2 
Serum pregnancy test (WOCBP only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH (post-menopausal women only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Viral serology (HIV antibody, HBsAg, 
HCV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COVID-19 Rapid Antigen Test: Group 
114 
X 
X14 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
COVID-19 Rapid Antigen Test: Groups 2 
and 314  
X 
X14 
 
X 
 
 
 
X 
 
 
 
X 
 
 
X 
 
ECG13 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Vital Signs: Group 116 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
X 
Vital Signs: Groups 2 and 316 
X 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
X 
X 
Urine sample for urinalysis13 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urine pregnancy test (WOCBP only) 15 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urine drug screen1 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Alcohol breath test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sino-nasal Outcome Test17 
X 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
X 
Clinical Safety Laboratory blood 
samples: Group 116 
X 
X 
 
 
X 
 
 
X 
 
 
 
 
 
 
X 
X 
Clinical Safety Laboratory blood 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
 
 
X 
X 

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Study Period 
Screening 
Treatment 
EoS 
 
 (-28 to 0) 
Day 1 
Day 
2 
Day 
3 
Day 
4 
Day 
5 
Day 
6 
Day 
7 
Day 
8 
Day 
9 
Day 
10 
Day 
11 
Day 
12 
Day 
13 
Day 
14 
Day 
28 
Visit Window (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
±2 
samples: Groups 2 and 316 
Collect serum for drug detection: Group 
12 
 
X 
 
 
X 
 
 
X 
 
 
 
 
 
 
X 
 
Collect serum for drug detection: Groups 
2 and 33 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
 
X 
 
Collect serum for anti-drug antibodies: 
Group 12 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
 
X 
 
Collect serum for anti-drug antibodies: 
Groups 2 and 33 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
 
X 
 
Collect nasal secretion sample: Group 1 
 
X4 
 
 
X5 
 
 
X5 
 
 
 
 
 
 
X 
 
Collect nasal secretion sample: Groups 2 
and 3 
 
X4 
 
X5 
 
 
 
X5 
 
 
 
 
 
 
X 
 
Administer study drug intranasally: 
Group 16 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
 
 
Administer study drug intranasally: 
Group 27  
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
 
Administer study drug intranasally: 
Group 38 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Record solicited and unsolicited 
AEs/SAEs9,10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Review diary: Group 1 19 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
X 

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Study Period 
Screening 
Treatment 
EoS 
 
 (-28 to 0) 
Day 1 
Day 
2 
Day 
3 
Day 
4 
Day 
5 
Day 
6 
Day 
7 
Day 
8 
Day 
9 
Day 
10 
Day 
11 
Day 
12 
Day 
13 
Day 
14 
Day 
28 
Visit Window (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
±2 
Review diary: Group 2 19 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
X 
X 
Review diary: Group 3 19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Abbreviations: AE=adverse event; BMI=Body mass index; ECG=Electrocardiogram; EoS=End of study; FSH=Follicle stimulating hormone; HBsAg=Hepatitis B surface antigen; 
HCV=Hepatitis C virus; HIV=Human immunodeficiency virus; IP=Investigational Product; RAT= Rapid Antigen Test; SAE=serious adverse event 
1. 
Urine toxicology screen for drugs of abuse. Urine toxicology screen and alcohol breath test to be done any time pre-dose on Day 1. 
2. 
Serum for detection of study drug and anti-drug antibodies will be collected before and 2 hours (±15 mins) after dosing on Day 1, and prior to dosing on Days 4, 7 and on Day 14 for 
Group 1 (refer Table 21-D). 
3. 
Serum for detection of study drug and anti-drug antibodies will be collected before and 2 hours (±15 mins) after dosing on Day 1 and prior to dosing on Days 3, 7 and on Day 14 for 
Groups 2 and 3 (refer Table 21-D). 
4. 
Intranasal mucosal lining fluid sample collected prior to dosing and 2 hours (±15 mins) after dosing on Day 1 
5. 
Intranasal mucosal lining fluid sample collected prior to dosing on Days 3 (Groups 2 and 3), 4 (Group 1), prior to dosing on Day 7 and on Day 14 
6. 
Group 1: Participants in Group 1 will be dosed once every third day during Day 1-12 
7. 
Group 2: Participants in Group 2 will be dosed once every other day during Day 1-12 
8. 
Group 3: Participants in Group 3 will be dosed once every day during Day 1-12 
9. 
Participants will be provided with a diary to record any solicited and/or unsolicited AEs, and to record concomitant medication usage. AEs to be recorded on each Day 1-28. 
10. Solicited local AEs: stuffy nose, runny nose, sneezing, nasal irritation, nasal tenderness/pain, loss of smell, sore throat scratchy throat, cough 
11. Vital signs be performed at Day 1 pre-dose, 15 min (± 5 min), 30 min (± 5 min), 1 hr (± 15 min), 4 hr  post-dose (± 15 min), and once on Days 3 (Groups 2 &3 only), 4 (Group 1 
only), 7, 14 and 28  
12. Targeted physical examination to be performed within 1 hour pre-dose on dosing days. Nasal examination to assess swelling of the mucosa, erythema, and secretions to be performed 
using nasal speculum and headlight within 1 hour pre-dose and 3 hours post dose on Day 1 and then at 3 hours post dose on Day 3 (Groups 2 and 3 only) or Day 4 (Group 1), 3 hours 
post dose on Day 7, 3 hours post dose on Day 10 (Group 1) or Day 11 (Group 2 and 3) and on Day 14. 
13. Urinalysis and ECG to be performed at Screening and at End of Study 
14. Covid-19 RAT test to be performed at screening and prior to dosing on Day 1 Day 3 (Groups 2 and 3 only) or Day 4 (Group 1), Day 7, Day 10 (Group 1) or Day 11 (Group 2 and 3) 
and Day 14. Participants testing positive will not be permitted to participate in the study. 
15. Urine pregnancy test to be performed any time prior to dose administration on Day 1; otherwise, may be performed any time on the scheduled day. 
16. To be performed within 1 hour prior to dose administration on dosing days; otherwise, may be performed any time on the scheduled day. 
17. Sino-Nasal Outcome Test to be performed at 2 hours (±15 mins) post-dose on dosing days; otherwise, test may be performed at any time on the scheduled day. 
18. Update only. 
19. Site staff to review diary at each clinic visit. Diary to be collected at the final EoS visit on Day 28. 

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21.2 Appendix 2. Pharmacokinetic and Immunogenicity Sampling Schedule 
Note: Where required, the timing of post-dose procedures will be in reference to 
administration of the last actuation completed 
21.2.1 
Part A (Single Dose) 
Table 21-C  Pharmacokinetic and Immunogenicity Sampling Schedule (Part A, 
Single Dose)  
Day 
Timepoint 
PK 
(blood) 
PK  
(nasal 
secretions) 
Immunogenicity  
(plasma) 
Time Window 
1 
Pre-dose 
X 
X 
X 
Any time prior to dose 
administration on the day 
Dose 
2 hr post-dose 
X 
X 
X 
± 15 min 
2 
Any 
X 
X 
X 
Any time on day 
8 
Any 
X 
X 
X 
Any time on day 
Abbreviations: PK = pharmacokinetic. 
 
21.2.2 
Part B (Multiple Dose) 
Table 21-D  Pharmacokinetic and Immunogenicity Sampling Schedule (Part B 
Multiple Dose) 
Day 
Timepoint 
PK 
(blood) 
PK  
(nasal 
secretions) 
Immunogenicity  
(plasma) 
Time Window 
1 
Pre-dose 
X 
X 
X 
Any time prior to dose 
administration on the day 
First Dose 
2 hr post-dose 
X 
X 
X 
± 15 min 
3  
(Groups 2 
& 3 only) 
Pre-dose 
X 
X 
X 
Any time prior to dose 
administration on the day 
4  
(Group 1 
only) 
Pre-dose 
X 
X 
X 
Any time prior to dose 
administration on the day 
7 
Pre-dose 
X 
X 
X 
Any time prior to dose 
administration on the day 
14 
End of Study 
X 
X 
X 
Any time on the day of 
EoS visit 
Abbreviations: PK = pharmacokinetic. 
 
 
 

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21.3 Appendix 3  Vital Signs Assessment Schedule 
Note: Where required, the timing of post-dose procedures will be in reference to 
administration of the last actuation completed 
21.3.1 
Part A (Single Dose) 
Table 21-E  Vital Signs Assessment Schedule (Part A, Single Dose) 
1 Includes pulse rate, blood pressure, oral temperature and respiratory rate 
21.3.2 
Part B (Multiple Dose) 
 
Table 21-F 
Vital Signs Assessment Schedule (Part B, Multiple Dose) 
Day 
Timepoint 
Vital 
Signs1 
Time Window 
Screen 
- 
X 
Any time on the scheduled day 
1 
1 hr pre-dose 
X 
Within 1 hour prior to dose administration 
Dose 
15 min post-dose 
X 
± 5 min 
30 min post-dose 
X 
± 5 min 
1 hr post-dose 
X 
± 15 min 
4 hr post-dose 
X 
± 15 min 
3  
(Groups 2 & 3 only) 
- 
X 
Any time on the scheduled day 
4  
(Group 1 only) 
- 
X 
Any time on the scheduled day 
7 
- 
X 
Any time on the scheduled day 
14 
- 
X 
Any time on the scheduled day 
28 
- 
X 
Any time on the scheduled day 
1 Includes pulse rate, blood pressure, oral temperature and respiratory rate 
 
 
Day 
Timepoint 
Vital Signs1 
Time Window 
Screen 
- 
X 
Any time on the scheduled day 
1 
pre-dose 
X 
Within 2 hour prior to dose administration 
Dose 
30 min post-dose 
X 
± 5 min 
1 hr post-dose 
X 
± 15 min 
4 hr post-dose 
X 
± 15 min 
2 
24 hr post-dose 
X 
± 2 hrs 
8 
- 
X 
Any time on the scheduled day 

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21.4 Appendix 4. Highly Effective Forms of Birth Control 
A highly effective method of contraception is one that has a failure rate of < 1% when used 
consistently and correctly and for this clinical study include the following: 
For female participants (of childbearing potential): 
• Established use of oral, injected or implanted hormonal methods of contraception for 
at least 1 month prior to Screening (SV1 for Phase Ib, MAD). 
• Placement of an intrauterine device (IUD) or intrauterine system (IUS) 
• Vasectomised partner (i.e., a female participant’s male partner has undergone 
effective surgical sterilisation (i.e., documented azoospermia at least 90 days after the 
procedure) before the female participant entered the clinical trial and he is the sole 
sexual partner of the female participant during the clinical trial) 
• Abstinence from heterosexual intercourse (acceptable only if it is the participant’s 
usual form of birth control/lifestyle choice) 
• Bilateral tubal occlusion 
Examples of non-acceptable methods of contraception include: 
• Condoms alone or double barrier 
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation) 
• Withdrawal 
For female partners (who are of childbearing potential) of male participants:  
• Established use of oral, injected or implanted hormonal methods of contraception for 
at least 1 month prior to Screening (SV1 for Phase Ib, MAD). 
• Placement of an intrauterine device (IUD) or intrauterine system (IUS) 
• Vasectomised partner (i.e., the male participant has undergone effective surgical 
sterilisation before entering the clinical trial) 
• Bilateral tubal occlusion 
 
Note that female participants who have been surgically sterilised (hysterectomy, bilateral 
salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or 
postmenopausal (where postmenopausal is defined as no menses for 12 months without an 
alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with 
postmenopausal status, per local laboratory guidelines), are not considered to be of 
childbearing potential.  
 

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21.5 Appendix 5: Clinical Laboratory Assessments 
 
Safety Assessments 
Haematology 
Serum Chemistry, Including 
Liver Function 
Coagulation 
• 
Haemoglobin 
• 
Haematocrit 
• 
Mean cell hemoglobin (MCH) 
• 
Mean cell volume (MCV) 
• 
Mean corpuscular hemoglobin 
concentration (MCHC) 
• 
Platelet count 
• 
RBC count 
• 
Red cell distribution width 
• 
Reticulocyte count 
• 
WBC count 
• 
Differential and leukocyte 
count (basophils, eosinophils, 
lymphocytes, monocytes, 
neutrophils) 
• 
Albumin 
• 
Alkaline phosphatase 
• 
ALT 
• 
Anion gap 
• 
ASTBicarbonate 
• 
Urea 
• 
Calcium 
• 
Calcium (adjusted) 
• 
Chloride 
• 
Creatinine 
• 
eGFR 
• 
GGT 
• 
Globulin 
• 
Ionised calcium 
• 
Lactate dehydrogenase 
• 
Phosphorus 
• 
Potassium 
• 
Sodium 
• 
Total bilirubin 
• 
Direct bilirubin  
• 
Indirect bilirubin 
• 
Total protein 
• 
Urea 
• 
Uric acid 
• 
Creatinine 
• 
PT 
• 
APTT 
• 
INR 
Urinalysis 1 
• 
Bilirubin 
• 
Blood 
• 
Glucose 
• 
Ketones 
• 
Leukocyte esterase 
• 
Nitrites 
• 
pH 
• 
Protein 
• 
Specific gravity 
• 
Urobilinogen 
 
1 Urine sediment microscopy will be 
conducted in the instance of 
abnormal urinalysis findings for 
blood and leukocyte esterase. 
Other Assessments 
Pregnancy Test 
Follicle-Stimulating Hormone 
Viral Serology 
• 
Urine hCG 
• 
Serum hCG 2 
 
2 If the urine hCG is positive, 
pregnancy will be confirmed by a 
serum hCG test 
FSH 
HIV antibody 
HBsAg 
HCV antibody 
Urine Drugs of Abuse 
 
Amphetamines 
Methamphetamines 
Methadone 
Barbiturates 
Benzodiazepine 
Cocaine 
Opiates 
Phencyclidine 
Tetrahydrocannabinol 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
CRP = C-reactive protein; FSH = follicle-stimulating hormone; HBsAg = Hepatitis B surface antigen; hCG = 
human chorionic gonadotropin; HCV = hepatitis C virus; HIV = Human Immunodeficiency Virus; RBC = red 
blood cell; ULN = upper limits of normal; WBC = white blood cell.