A Double-blind, Randomised, Placebo-controlled Phase I Trial to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Topical Doses of GZ21T in Healthy Volunteers
Phase: PHASE1
Conditions: Actinic Keratosis
Sponsor: Genzada Pharmaceuticals USA, Inc.

 
 
 
 
Study title 
 
A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PHASE I TRIAL TO 
INVESTIGATE SAFETY, TOLERABILITYAND PHARMACOKINETICS OF SINGLE 
ASCENDING TOPICAL DOSES OF GZ21T IN HEALTHY VOLUNTEERS 
 
 
NCT Number  
 
 
NCT06888362 
 
 
Clinical Trial Protocol 
 
v2.0; 20NOV2024 

Ankh Life Sciences Limited 
Clinical Trial Protocol, A24-0001, Final v2.0 
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The following amendments have been made to the first submitted version of this Clinical Trial 
Protocol (version 1.0) 
 
Type of change 
Date 
Summary of changes 
Revised protocol 
version 
 
 
Substantial 
amendment 
20NOV2024 
An additonal part (Part B) has been 
added to include 1 cohort 
(3 particpants), and up to 2 optional 
cohorts with 3 participants in each 
cohort, in order to evaluate the 
optimum amount of cream to be 
applied to a given body area 
(dose/area). 
Version 1.0 
 
 
 

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1 
TRIAL SYNOPSIS 
 
Trial title 
A double-blind, randomised, placebo-controlled Phase I trial to investigate safety, tolerability, and 
pharmacokinetics of single ascending topical doses of GZ21T in healthy volunteers. 
Trial code 
A24-0001 
EU Trial No. 
2024-512893-86-00 
Planned trial period 
Q2 2024 to Q1 2025 
Phase of development 
I 
Principal Investigator 
Mohammad Alimohammadi, MD, PhD 
CTC Clinical Trial Consultants AB 
Dag Hammarskjölds väg 10B 
SE-752 37 Uppsala, Sweden 
Trial background 
The Sponsor, Ankh Life Sciences Limited, is developing GZ21T as a topical treatment of actinic 
keratosis. GZ21T is a fixed combination of isovanillin, curcumin, and harmine that has been shown 
to have anti-tumour activity, partially due to the activation of the kinase ataxia-telangiectasia mutated 
(ATM) and the adenosine monophosphate (AMP)-dependent protein kinase (AMPKα) T172, in 
addition to enhanced autophagy. In vitro studies on actinic keratosis cells have demonstrated that 
GZ21T induces 2 complementary cell-killing processes that converge on the mitochondrion to cause 
caspase-dependent and -independent cell death. 
Trial design and trial population 
This is a Phase I trial divided in 2 parts. Part A is double-blind, randomised, placebo-controlled and 
designed to evaluate safety, tolerability, pharmacokinetics (PK), after topical administration of single 
ascending doses of GZ21T in healthy volunteers. Part B is open-label and designed to evaluate the 
optimum amount of cream applied to a given body area (dose/area) of single doses of GZ21T in 
healthy volunteers. 
Objectives 
Part A 
Primary objective 
• 
To evaluate the safety and tolerability of GZ21T after single topical dose applications. 
Secondary objective 
• 
To investigate the potential systemic exposure and PK properties of GZ21T after single topical 
dose applications. 
Part B 
Primary objective 
• 
To investigate the optimum amount of GZ21T cream applied to a given area (dose/area) after 
single topical dose applications. 

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Participants will come for 3 visits to the research clinic for screening, treatment, and follow-up. 
Screening (Visit 1) will take place between Day -28 and Day -1. Eligible participants will be 
admitted to the research clinic between Day 1 and Day 2 (Visit 2) for randomisation, investigational 
medicinal product (IMP) administration and pre- and post-dose safety and PK assessments. 
In each cohort, a single dose of the IMP will be topically applied to the selected area. The treated 
area will be marked with a medical skin waterproof marker. During that time, participants should 
remain still without touching the treated area. Before treatment on Day 1, participants must have 
abstained from using moisturising ointments, creams, or emollients for 24 hours on the area to be 
treated. 
Sentinel dosing will be applied. The first 2 participants in each cohort will receive either GZ21T or 
placebo as randomised. After the sentinel participants, at least 24 hours must pass before dosing of 
the remaining participants to give sufficient time for the observation of any reactions. 
All participants will be carefully monitored by clinical staff during and after IMP application and 
will remain at the research clinic for at least 24 hours after treatment (Day 2) for safety assessments, 
including safety laboratory testing, 12-lead ECG, vital signs, local tolerability, physical examination 
and AEs, and PK assessments. Participants will return to the research clinic on Day 7±1 day (Visit 3) 
for final safety and PK assessments. 
Before initiating a new cohort, all participants in the previous cohort(s) must have been dosed and 
observed for at least 24 hours for safety and tolerability and to obtain blood samples for PK analysis. 
The PK data, up to and including 24 hours data, for all treated participants must have been reviewed 
by the internal safety review committee (iSRC) before initiating a new cohort. Once safety, 
tolerability, and PK data of the last participant in each cohort has been collected, there must be at 
least 1 week between dose escalations to allow for a thorough evaluation of data. 
Part B 
Participants will receive a single topical application of GZ21T. 
• 
Cohort 1: 
 mg/cm2 GZ21T will be applied to 
 cm2 of the skin, corresponding to 
approximately % BSA and 
 g cream. Up to 2 optional cohorts may be added. The doses in 
the optional cohorts may be higher or lower but will not exceed the doses in Part A. 
Participants will come for 3 visits to the research clinic for screening, treatment, and follow-up, and 
will have 1 remote telephone visit. Screening (Visit 1) will take place between Day -28 and Day -1. 
Eligible participants will visit the research clinic on Day 1 (Visit 2) for IMP administration and 
cream absorption evaluation and local tolerability assessments. 
A single dose of the IMP will be topically applied to the selected area. The treated area will be 
marked with a medical skin waterproof marker. During that time, participants should remain still 
without touching the treated area. Before treatment on Day 1, participants must have abstained from 
using moisturising ointments, creams, or emollients for 24 hours on the area to be treated. 
All participants will be carefully monitored by clinical staff during and after IMP application and 
will remain at the research clinic for 2 hours after treatment for local tolerability and AE evaluation. 
On Day 2 (Visit 3), 24 hours post-dose, participants will visit the research clinic for follow-up of 
local tolerability and AEs. A remote telephone call will be performed on Day 7 ±1 day (Visit 4) to 
follow-up on local tolerability and AEs. 

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Investigational Medicinal Product, dosage and mode of administration 
The IMPs will be provided as GZ21T cream, 15 mg/g (1.5%), tubes of each 7 gram, and placebo for 
GZ21T cream, 0 mg/g, tubes of each 7 grams. 
Doses for Part A: 
• 
Cohort 1: 
 g GZ21T or placebo will be applied to 
 cm2 of the skin, corresponding to 
approximately % BSA. 
• 
Cohort 2: 
 g GZ21T or placebo will be applied to 
 cm2 of the skin, corresponding to 
approximately 
% BSA. 
• 
Cohort 3: 
 g GZ21T or placebo will be applied to 
 cm2 of the skin, corresponding to 
approximately 
% BSA. 
• 
Cohort 4: 
 g GZ21T or placebo will be applied to the face, corresponding to approximately 
% BSA. 
Doses for Part B: 
• 
Cohort 1: 
 g GZ21T will be applied to 
 cm2 of the skin. The doses for the optional 
cohorts (cohorts 2 and 3) will be decided based on the results from the previous cohorts. The 
doses will not exceed the doses given in Part A. 
Duration of treatment 
Single topical dose application. 
Duration of each participant’s involvement in the trial 
In both parts, each participant is expected to participate in the trial for a maximum of 35 days 
including an up to 28-days screening period. 
Safety assessments 
• 
AEs 
• 
Local tolerability 
• 
Clinical laboratory parameters 
• 
Vital signs (blood pressure, pulse) 
• 
12-lead ECG 
• 
Physical examinations 
Pharmacokinetic assessments 
Part A: Blood sampling for subsequent bioanalysis of GZ21T plasma concentrations and calculation 
of PK parameters. 
Ethical Considerations and Benefit-risk Analysis 
While keeping the identified risk factors at a minimum level in order to not expose the participants 
participating in the trial to risks that would not be ethically justifiable, it is concluded that the 
planned trial assessments are considered sufficient to meet the scientific and medical goals for the 
trial. It is therefore concluded that the potential benefits from the trial will outweigh the potential 
risks for the treated participants. 

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Statistical methods 
No formal sample size calculation has been performed. The proposed sample size is considered 
sufficient to provide adequate information for the trial endpoints. 
Data will be summarised using descriptive statistics as appropriate. All descriptive summaries and 
statistical analyses will be performed using SAS Version 9.4 or later (SAS Institute, Inc., Cary, NC). 
Trial reporting 
After completion of the trial, an International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use (ICH) E3 guideline-compliant clinical trial report (CTR) will be 
prepared. 

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2 
TABLE OF CONTENTS 
1 
TRIAL SYNOPSIS ....................................................................................................... 3 
2 
TABLE OF CONTENTS ............................................................................................. 8 
2.1 
List of tables ................................................................................................................ 12 
2.2 
List of figures .............................................................................................................. 12 
3 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ........................... 13 
4 
IMPORTANT MEDICAL PROCEDURES TO BE FOLLOWED BY THE 
INVESTIGATOR ....................................................................................................... 16 
4.1 
Medical emergencies contact ..................................................................................... 16 
5 
INVESTIGATOR AND TRIAL ADMINISTRATIVE STRUCTURE ................. 17 
6 
INTRODUCTION ...................................................................................................... 19 
6.1 
Background ................................................................................................................. 19 
6.1.1 
Summary of non-clinical data ................................................................................... 19 
6.1.2 
Clinical experience ................................................................................................... 21 
6.2 
Trial rationale ............................................................................................................. 22 
6.3 
Risk/benefit assessment .............................................................................................. 22 
6.3.1 
General risk/benefit assessment ................................................................................ 22 
7 
TRIAL OBJECTIVES AND ENDPOINTS ............................................................. 24 
7.1 
Trial objectives and endpoints ................................................................................... 24 
8 
TRIAL DESIGN ......................................................................................................... 26 
8.1 
Overall trial design and schedule of events .............................................................. 26 
8.2 
Rationale for trial design ........................................................................................... 35 
8.3 
Selection of starting dose and rationale for planned dose escalation ..................... 35 
8.3.1 
Selection of starting dose .......................................................................................... 35 
8.3.2 
Rationale for dose choices ........................................................................................ 36 
8.3.3 
Maximum dose ......................................................................................................... 36 
8.3.4 
Stopping criteria for dose escalation (Part A) .......................................................... 36 
8.3.5 
Internal Safety Review Committee (Part A) ............................................................. 38 
9 
TRIAL POPULATION .............................................................................................. 39 
9.1 
Recruitment ................................................................................................................. 39 
9.2 
Screening and enrolment log ..................................................................................... 39 
9.3 
Number of participants .............................................................................................. 39 
9.4 
Inclusion criteria ......................................................................................................... 39 
9.5 
Exclusion criteria ........................................................................................................ 40 
9.6 
Restrictions during the trial ....................................................................................... 42 
9.6.1 
General restrictions ................................................................................................... 42 
9.6.2 
Prior and concomitant therapy .................................................................................. 42 

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9.7 
Screen failures ............................................................................................................. 43 
9.8 
Participant withdrawal .............................................................................................. 43 
9.8.1 
General withdrawal criteria ...................................................................................... 43 
9.8.2 
Procedures for discontinuation of a participant from the trial .................................. 44 
9.8.3 
Participant replacement ............................................................................................ 44 
9.9 
Randomisation (Part A) ............................................................................................. 44 
9.10 
Blinding........................................................................................................................ 45 
9.11 
Emergency unblinding during the trial .................................................................... 45 
10 
TRIAL TREATMENTS ............................................................................................. 46 
10.1 
Identity of investigational medicinal products ......................................................... 46 
10.2 
Manufacturing, packaging, labelling and release .................................................... 46 
10.3 
Conditions for storage ................................................................................................ 46 
10.4 
Preparation and accountability ................................................................................. 46 
10.5 
Treatment administration .......................................................................................... 46 
10.6 
Continuation of treatment with investigational medicinal product ....................... 47 
10.7 
Treatment compliance ................................................................................................ 47 
10.8 
Return and destruction of investigational medicinal product ................................ 47 
11 
TRIAL ASSESSMENTS ............................................................................................ 48 
11.1 
Recording of data ........................................................................................................ 48 
11.2 
Demographics and other baseline characteristics .................................................... 48 
11.2.1 
Informed consent ...................................................................................................... 48 
11.2.2 
Eligibility criteria ...................................................................................................... 48 
11.2.3 
Demographic information ......................................................................................... 48 
11.2.4 
Height, weight, and body mass index and body surface area ................................... 48 
11.2.5 
Medical/surgical history ........................................................................................... 48 
11.2.6 
HIV and Hepatitis B/C ............................................................................................. 49 
11.2.7 
Pregnancy test ........................................................................................................... 49 
11.2.8 
Urine drug-screen ..................................................................................................... 49 
11.2.9 
Alcohol test ............................................................................................................... 49 
11.2.10 Baseline symptoms ................................................................................................... 49 
11.2.11 Prior and concomitant medication ............................................................................ 49 
11.3 
Assessments related to primary endpoints ............................................................... 49 
11.3.1 
Adverse events .......................................................................................................... 49 
11.3.2 
Local tolerability ....................................................................................................... 56 
11.3.3 
Vital signs ................................................................................................................. 57 
11.3.4 
Electrocardiogram ..................................................................................................... 57 
11.3.5 
Safety laboratory assessments .................................................................................. 57 

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11.3.6 
Physical examinations .............................................................................................. 58 
11.3.7 
Cream absorption evaluation (Part B) ...................................................................... 59 
11.4 
Assessments related to secondary endpoints ............................................................ 59 
11.4.1 
Pharmacokinetic sampling and analysis (Part A) ..................................................... 59 
11.5 
Appropriateness of measurements ............................................................................ 59 
12 
PROCEDURES FOR BIOLOGICAL SAMPLES .................................................. 60 
12.1 
Sample collection ........................................................................................................ 60 
12.2 
Volume of blood .......................................................................................................... 60 
12.3 
Handling, storage and destruction of laboratory samples ...................................... 60 
12.4 
Chain of custody of biological samples ..................................................................... 60 
12.5 
Withdrawal of informed consent for donated biological samples .......................... 61 
13 
QUALITY MANAGEMENT, QUALITY ASSURANCE AND QUALITY 
CONTROL .................................................................................................................. 62 
13.1 
Quality management: critical process, system, and data identification ................ 62 
13.2 
Quality assurance and quality control ...................................................................... 62 
14 
ETHICAL AND REGULATORY REQUIREMENTS ........................................... 63 
14.1 
Ethical conduct of the trial ........................................................................................ 63 
14.2 
Ethics and regulatory review ..................................................................................... 63 
14.3 
Participant information and consent ........................................................................ 63 
14.4 
Participant information card ..................................................................................... 63 
14.5 
Participant privacy and data protection ................................................................... 64 
14.6 
Data security breach ................................................................................................... 65 
14.7 
Changes to the authorised clinical trial protocol ..................................................... 65 
14.8 
Audits and regulatory inspections ............................................................................. 65 
14.9 
Insurance ..................................................................................................................... 65 
15 
TRIAL MANAGEMENT .......................................................................................... 66 
15.1 
Training of trial site personnel .................................................................................. 66 
15.2 
Clinical monitoring ..................................................................................................... 66 
15.3 
Source data documents .............................................................................................. 67 
15.4 
Trial agreements ......................................................................................................... 67 
15.5 
Trial timetable and end-of-trial ................................................................................. 67 
15.6 
Temporary halt or Early termination of the trial ................................................... 67 
15.7 
Reporting of serious breach ....................................................................................... 68 
15.8 
Reporting of urgent safety measures ........................................................................ 68 
15.9 
Reporting and publication ......................................................................................... 68 
15.9.1 
Registration in a publicly accessible database .......................................................... 68 
15.9.2 
Public disclosure ....................................................................................................... 68 

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15.9.3 
Summary of results and clinical trial report ............................................................. 69 
15.9.4 
Annual safety report ................................................................................................. 69 
15.9.5 
Confidentiality and ownership of trial data .............................................................. 69 
15.9.6 
Publication ................................................................................................................ 69 
15.10 
Archiving ................................................................................................................. 69 
16 
DATA MANAGEMENT ............................................................................................ 70 
16.1 
The web-based eCRF .................................................................................................. 70 
16.2 
The entering of data into the eCRF........................................................................... 70 
16.3 
The query process ....................................................................................................... 70 
16.4 
Audit trail .................................................................................................................... 71 
16.5 
External data ............................................................................................................... 71 
16.6 
Medical coding ............................................................................................................ 71 
16.7 
Database lock .............................................................................................................. 71 
17 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE ...... 72 
17.1 
General ........................................................................................................................ 72 
17.2 
Determination of sample size ..................................................................................... 72 
17.3 
Analysis data sets ........................................................................................................ 72 
17.4 
Missing, unused and spurious data ........................................................................... 72 
17.5 
Description of trial population................................................................................... 73 
17.5.1 
Demographics and baseline characteristics .............................................................. 73 
17.5.2 
Medical/surgical history and prior/concomitant medication .................................... 73 
17.5.3 
Investigational medicinal product use ...................................................................... 73 
17.6 
Analysis of primary endpoints ................................................................................... 73 
17.6.1 
Adverse events .......................................................................................................... 73 
17.6.2 
Local tolerability ....................................................................................................... 73 
17.6.3 
Vital signs ................................................................................................................. 73 
17.6.4 
Electrocardiogram ..................................................................................................... 73 
17.6.5 
Safety laboratory ....................................................................................................... 74 
17.6.6 
Physical examinations .............................................................................................. 74 
17.6.7 
Cream abosorption (Part B) ...................................................................................... 74 
17.7 
Analysis of secondary endpoints ............................................................................... 74 
17.7.1 
Analysis of pharmacokinetics (Part A) ..................................................................... 74 
18 
REFERENCES ........................................................................................................... 75 
19 
SIGNATURES ............................................................................................................ 77 
19.1 
Approval of the clinical trial protocol ....................................................................... 77 
19.2 
Principal Investigator statement ............................................................................... 78 

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2.1 
List of tables 
 
Table 4.1-1 
Medical emergencies contact 
16 
Table 7.1-1 
Trial objectives and endpoints (Part A) 
24 
Table 7.1-2 
Trial objective and endpoint (Part B) 
25 
Table 8.1-1 
Overall schedule of events (Part A) 
29 
Table 8.1-2 
Detailed schedule of events for Visit 2 (Part A) 
31 
Table 8.1-3 
Overall schedule of events (Part B) 
32 
Table 8.1-4 
Detailed schedule of events for Visit 2 and Visit 3, Part B 
34 
Table 8.3-1 
Dose escalation and stopping criteria 
37 
Table 11.3-1 
Local tolerability evaluation scale 
57 
Table 11.3-2 
Safety laboratory parameters 
58 
Table 12.2-1 
Estimated blood volumes (Part A) 
60 
Table 12.2-2 
Estimated blood volumes (Part B) 
60 
2.2 
List of figures 
Figure 8.1-1 
Trial design and proposed doses 
26 

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3 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Explanation 
 
ADHD 
Attention deficit hyperactivity disorder 
ADL 
Activities of daily living 
AE 
Adverse event 
ALP 
Alkaline phosphatase 
ALT 
Alanine aminotransferase 
AMP 
Adenosine monophosphate 
AMPKα 
AMP-activated protein kinase 
APTT 
Activated partial thromboplastin clotting time 
AR 
Adverse reaction 
AST 
Aspartate aminotransferase 
ATC 
Anatomical therapeutic chemical 
ATM 
Ataxia-telangiectasia mutated 
AUC 
Area under the plasma concentration vs. time curve 
AUCinf 
AUC from 0 to infinity 
AUClast 
AUC from 0 to the time of the last measurable plasma 
concentration 
B-EVF 
Blood erythrocyte volume fraction 
BID 
Two times daily (Latin bis in die) 
BMI 
Body mass index 
BSA 
Body surface area 
bw 
Body weight 
Cmax 
Maximum observed concentration 
CRO 
Contract research organisation 
CTIS 
Clinical Trials Information System (EU portal) 
CTP 
Clinical trial protocol 
CTR 
Clinical trial report 
CTC 
Clinical Trial Consultants AB 
CTCAE 
Common terminology criteria for adverse events 
CV 
Coefficient of variation 
DBL 
Database lock 
DMP 
Data management plan 
DNA 
Deoxyribonucleic acid 
ECG 
Electrocardiogram 

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Abbreviation 
Explanation 
 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EEA 
European Economic Area 
eGFR 
Estimated glomerular filtration rate 
EMA 
European Medicines Agency 
EU 
European Union 
FAS 
Full analysis set 
FDA 
United States Food and Drug Administration 
FIH 
First-in-human 
FSH 
Follicle-stimulating hormone 
GCP 
Good clinical practice 
GDP 
Good distribution practice 
GDPR 
General data protection regulation 
GMP 
Good manufacturing practice 
Hb 
Haemoglobin 
hCG 
Human chorionic gonadotropin 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
ICTRP 
International clinical trials registry platform 
IEC 
Independent ethics committee 
IMP 
Investigational medicinal product 
ISF 
Investigator site file 
iSRC 
Internal safety review committee 
IUD 
Intra-uterine device 
IUS 
Intra-uterine system 
MCH 
Mean corpuscular haemoglobin 
MCV 
Mean corpuscular volume 
MedDRA 
Medical dictionary for regulatory activities 
NIH 
National Institutes of Health 
NOAEL 
No observed adverse effect level 
NSAID 
Non-steroidal anti-inflammatory drug 

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Abbreviation 
Explanation 
 
PD 
Protocol deviation 
PII 
Personally identifiable information 
PK 
Pharmacokinetic(s) 
PK(INR) 
Prothrombin complex international normalised ratio 
PKAS 
PK analysis set 
PR interval 
(ECG) The time from the onset of the P wave to the start of 
the QRS complex 
PT 
Preferred term 
QA 
Quality assurance 
QC 
Quality control 
QP 
Qualified person 
QRS interval 
(ECG) The time required for stimulus to spread through the 
heart’s ventricles 
QT interval 
(ECG) The time from the beginning of the QRS complex to 
the end of the T wave 
QTcF 
(ECG) Corrected QT interval by Fredericia 
RBM 
Risk-based monitoring 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAR 
Serious adverse reaction 
SAS 
Statistical analysis software 
SD 
Standard deviation 
SDV 
Source data verification 
SMP 
Safety management plan 
SOC 
System organ class 
SOP 
Standard operating procedures 
SUSAR 
Suspected unexpected serious adverse reaction 
TMF 
Trial master file 
Tmax 
Time of occurrence of Cmax 
T1/2 
Terminal elimination half-life 
WHO 
World Health Organization 
WOCBP 
Women of childbearing potential 

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4 
IMPORTANT MEDICAL PROCEDURES TO BE FOLLOWED BY THE 
INVESTIGATOR 
4.1 
Medical emergencies contact 
The Principal Investigator is responsible for ensuring that procedures and expertise are 
available to handle medical emergencies during the trial. A medical emergency usually 
constitutes a serious adverse event (SAE) and is to be reported as such. Detailed SAE 
reporting procedures are described in Section 11.3.1.14. 
In the case of a medical emergency, the Investigator may, during office hours, contact the 
Medical Monitor (Table 4.1-1). 
Table 4.1-1 
Medical emergencies contact 
 
Name 
Function in the trial 
Telephone number 
E-mail 
 
 
 
 

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Overdosing is not likely to occur since all IMP will be applied by site personnel under 
medical surveillance. In cases of accidental overdose, standard supportive measures should be 
adopted as required. For further information, refer to Section 11.3.1.19. 
Each participant will be provided with a participation card with information about their 
participation in a trial, refer to Section 14.4. 
The Principal Investigator at the trial site will ascertain that adequate facilities and procedures 
are available to handle emergencies should they occur during the trial. The medical staff at 
CTC have extensive experience from early Phase trials, and there are adequate procedures in 
place to handle unexpected and expected ARs in the trial participants. 
Aside from the risks related to GZ21T, as detailed above, there may also be risks related to 
the medical devices used in the trial (e.g., indwelling venous catheters). However, these 
devices are used in routine medical care and the risk associated with their use is considered 
low and ethically justifiable. Trial-specific evaluations and sampling procedures, such as 
blood pressure measurements using a blood pressure cuff and frequent blood sampling, may 
cause transient discomfort but the risk is deemed to be low and ethically justifiable. Overall, 
the combined safety data from previous pre-clinical and clinical trials have not revealed any 
safety issues that would outweigh the expected benefits of the trial. 
While keeping the risk mentioned above factors at a minimum level in order to not expose the 
participants taking part in the trial to risks that would not be ethically justifiable, it is 
concluded that the planned trial assessments are considered sufficient to meet the scientific 
and medical goals for the trial. It is therefore concluded that the potential benefits from the 
trial will outweigh the potential risks for the treated participants. 
More detailed information about the known and expected benefits and risks and reasonably 
expected ARs are found in the current version of the GZ21T IB (version 1.0). 

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7 
TRIAL OBJECTIVES AND ENDPOINTS 
The trial objectives and endpoints are summarised in Table 7.1-1 (Part A) and Table 7.1-2 
(Part B). 
7.1 
Trial objectives and endpoints 
Table 7.1-1 
Trial objectives and endpoints (Part A) 
 
Objectives 
Endpoints 
Assessments 
Analysis 
Primary 
To evaluate the safety and 
tolerability of GZ21T after 
single topical dose 
applications. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Secondary 
To investigate the 
potential systemic 
exposure and 
pharmacokinetic (PK) 
properties of GZ21T after 
single topical dose 
applications. 
Frequency, severity and intensity of 
AEs. 
 
Local tolerability reactions: 
Erythema, swelling, pruritus, burning, 
blistering and urticaria, discoloration 
and dryness (Investigator’s assessment 
0-3 none/mild/moderate/severe). 
Clinically significant changes in vital 
signs, electrocardiograms (ECGs), 
safety laboratory measurements 
(haematology, clinical chemistry, 
coagulation) and physical examination 
findings. 
 
 
 
 
 
 
 
Plasma concentrations of GZ21T after 
single dose applications. 
PK parameters after a single dose 
application (to be calculated if data 
permits): area under the plasma 
concentration curve from time 0 to 
infinity (AUCinf), AUC from time 0 to 
the last measurable concentration 
(AUClast), maximum plasma 
concentration (Cmax), time to Cmax 
(Tmax), terminal elimination half-life 
(T½). 
AE reporting and 
questioning 
(Section 11.3.1). 
Local tolerability 
reactions 
(Section 11.3.2). 
 
 
Blood pressure and 
pulse (Section 11.3.3). 
12-lead ECG 
(Section 11.3.4). 
Blood sampling for 
haematology, clinical 
chemistry and 
coagulation 
(Section 11.3.5). 
Physical examinations 
(Section 11.3.6). 
 
PK sampling and 
analysis 
(Section 11.4.1). 
Section 17.6.1. 
 
 
Section 17.6.2. 
 
 
 
 
Section 17.6.3. 
 
Section 17.6.4. 
 
Section 17.6.5. 
 
 
 
 
Section 17.6.6. 
 
 
Section 17.7.1. 
 
 

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Table 7.1-2 
Trial objective and endpoint (Part B) 
 
Objectives 
Endpoints 
Assessments 
Analysis 
Primary 
To investigate the 
optimum amount of cream 
applied to a given area 
(dose/area) after single 
topical dose applications. 
Cream absorption after single dose 
applications. 
Evaluation of cream 
absorption 
(Section 11.3.7). 
Section 17.6.7 
 
 

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In Part A, participants will come for 3 visits to the research clinic for screening, treatment, 
and follow-up. Screening (Visit 1) will take place between Day -28 and Day -1. Eligible 
participants will be admitted to the research clinic between Day 1 and Day 2 (Visit 2) for 
randomisation, IMP administration and pre- and post-dose safety and PK assessments. 
In each cohort, a single dose of the IMP will be topically applied to the selected area. The 
treated area will be marked with a medical skin waterproof marker. During that time, 
participants should remain still without touching the treated area. Before treatment on Day 1, 
participants must have abstained from using moisturising ointments, creams, or emollients for 
24 hours on the area to be treated. 
Sentinel dosing will be applied. The first 2 participants in each cohort will receive either 
GZ21T or a placebo as randomised. After the sentinel participants, at least 24 hours must pass 
before dosing of the remaining participants to give sufficient time for the observation of any 
reactions. 
All participants will be carefully monitored by clinical staff during and after IMP application 
and will remain at the research clinic for at least 24 hours after treatment (Day 2) for safety 
assessments, including safety laboratory testing, 12-lead electrocardiogram (ECG), vital signs, 
local tolerability and AEs, and PK assessments. Participants will return to the research clinic 
on Day 7±1 day (Visit 3) for final safety and PK assessments. 
Before initiating a new cohort, all participants in the previous cohort(s) must have been dosed 
and observed for at least 24 hours for safety and tolerability and to obtain blood samples for 
PK analysis. The PK data, up to and including 24 hours data, for all treated participants must 
have been reviewed by the iSRC before initiating a new cohort. Once safety, tolerability, and 
PK data of the last participant in each cohort has been collected, there must be at least 1 week 
between dose escalations to allow for a thorough evaluation of data. 
Each participant is expected to participate in Part A of the trial for a maximum of 35 days 
including an up to 28-day screening period. 
The overall schedule of events for Part A of the trial is shown in Table 8.1-1, and the detailed 
schedule of events for Visit 2 is shown in Table 8.1-2. Trial assessments are described in 
Section 11. 
In Part B, Participants will come for 3 visits to the research clinic for screening, treatment, 
and follow-up, and will have 1 remote telephone visit. Screening (Visit 1) will take place 
between Day -28 and Day -1. Eligible participants will visit the research clinic on Day 1 
(Visit 2) for IMP administration cream absorption evaluation and local tolerability 
assessments. 
A single dose of the IMP will be topically applied to the selected area. The treated area will be 
marked with a medical skin waterproof marker. During that time, participants should remain 
still without touching the treated area. Before treatment on Day 1, participants must have 
abstained from using moisturising ointments, creams, or emollients for 24 hours on the area to 
be treated. 
All participants will be carefully monitored by clinical staff during and after IMP application 
and will remain at the research clinic for 2 hours after treatment for local tolerability and AE 
evaluation. On Day 2 (Visit 3), approximately 24 hours post-dose, participants will visit the 
research clinic for follow-up of local tolerability and AEs. A remote telephone call will be 
performed on Day 7 ±1 day (Visit 4) to follow-up on local tolerability and AEs. 

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Each participant is expected to participate in Part B of the trial for a maximum of 35 days, 
including an up to 28-day screening period. 
The schedule of events for Part B of the trial is shown in Table 8.1-3 and the detailed schedule 
for Visit 2 and Visit 3 is shown in Table 8.1-4. Trial assessments are described in Section 11. 

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4. 
BSA will be calculated from the weight and height. 
5. 
Symptom-driven physical examination. 
6. 
Women of childbearing potential (WOCBP) only. At screening: plasma/serum test. At other visits: urine test. 
7. 
Clinical chemistry, haematology, and coagulation. 
8. 
Blood pressure, and pulse. 
9. 
Dryness and discoloration will be assessed pre-dose, and 24 hours and 7 days post-dose. 
10. Meals Day 1: breakfast (optional), lunch, snack (optional), dinner, and evening snack will be served during the day. Meals Day 2: breakfast only. 
11. Baseline symptoms will be recorded up until the administration of IMP on Day 1. 
12. AEs will be recorded from the first administration of IMP. 

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6. 
Clinical chemistry, haematology, and coagulation. 
7. 
Blood pressure, and pulse. 
8. 
Local tolerability assessments will be done 2 hours post-dose. Dryness and discoloration will be assessed pre-dose, and 24 hours post-dose. 
9. 
Baseline symptoms will be recorded up until the administration of IMP on Day 1. 
10. AEs will be recorded from the first administration of IMP. 

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No systemic toxicity was observed when GZ21T at doses up to 
 bw were applied 
topically to minipigs for 28 days. Furthermore, there was very low systemic exposure to 
GZ21T in the study. It is therefore difficult to establish stopping rules based on GZ21T 
exposure which have been reflected in the stopping rules defined in Table 8.3-1. A thorough 
evaluation with respect to safety criteria will be performed. 
Table 8.3-1 
Dose escalation and stopping criteria 
 
No. Stopping criterion 
Action taken 
At the individual and cohort level 
1 
If no participant has an serious 
adverse event (SAE) considered at 
least possibly related to the IMP 
administration, i.e., a serious 
adverse reaction (SAR). 
2 
If 1 participant on active treatment 
has an SAE assessed as at least 
possibly related to IMP 
administration. 
 
 
 
 
 
 
 
 
3 
If 2 participants on active treatment 
in the same cohort have severe, 
non-serious AEs assessed at least 
possibly related to the IMP 
administration (independent of 
whether the AEs are within the 
same system organ class [SOC]). 
 
 
 
 
Final dosing stop and termination of trial 
4 
If 2 participants on active treatment 
have SAEs assessed as at least 
possibly related to IMP 
administration. 
Escalate to the next higher dose level. 
 
 
 
 
1. Stop dosing the participant with a potential SAR. Await the 
dosing of additional participants until the iSRC’s 
recommendation and the Sponsor’s decision on continuation. 
2. Unblind the participant with potential SAR. Only voting 
members of the iSRC will be unblinded. 
3. Evaluation by the iSRC. The iSRC makes a recommendation 
to the Sponsor. 
4. The Sponsor decides how to proceed. 
The participant received active treatment, i.e., met the stop 
criterion: stop further dosing at this dose level for all participants. 
The Sponsor decides if the trial will be terminated or if dosing 
will resume at a lower dose level. 
1. Stop dosing the participants with severe, non-serious potential 
ARs. 
2. Unblind the participants with potential ARs. Only voting 
members of the iSRC will be unblinded. 
3. Evaluation by the iSRC. The iSRC makes a recommendation 
to the Sponsor. 
4. The Sponsor decides how to proceed. 
Both participants received active treatment, i.e., met the stop 
criterion: stop further dosing at this dose level for all participants. 
The Sponsor decides if the trial will be terminated or if dosing 
should resume at a lower dose level. 
 
 
1. Stop dosing the participants with potential SARs. Await 
dosing additional participants until the iSRC’s 
recommendation and the Sponsor’s decision on continuation. 
2. Unblind the participants with potential SARs. Only voting 
members of the iSRC will be unblinded. 
3. Evaluation by the iSRC. The iSRC makes a recommendation 
to the Sponsor. 
4. The Sponsor decides how to proceed. 
Both participants received active treatment, i.e., met the stop 
criterion: Termination of trial. 
One (1) participant received active treatment, i.e., met stop 
criterion: See stop criterion no. 2. 
 
 

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8.3.5 
Internal Safety Review Committee (Part A) 
The voting members of the iSRC will consist of the Principal Investigator, the CTC Medical 
Monitor and the Sponsor’s Medical Representative. In addition, the trial clinical research 
manager, the trial pharmacokineticist and additional Sponsor representatives will be invited as 
appropriate and function as non-voting members. Other internal or external experts may be 
invited and consulted by the iSRC as appropriate. 
Before initiating a new dose cohort, all participants in the previous cohort must have been 
treated and all available safety, tolerability, and plasma concentration data up until and 
including 24 hours after dosing must have been evaluated by the iSRC. After collection of the 
last available 24-hour data, there will be at least 1 week between dose escalations. In case of 
dropouts, available data for the dropouts will be included in the iSRC evaluation. If the 
GZ21T drug is considered safe and tolerable, the recommended next dose level, based on the 
predicted exposure, will be provided to the Sponsor in writing. Based on the emerging safety 
and plasma PK data, the amount of required data to be reviewed after each completed cohort 
may be adjusted. Likewise, the number of dose levels and planned sampling times may also 
be adjusted. These adjustments will be documented in non-substantial modifications to the 
CTP. Details regarding the timing of iSRC reviews and the data to be reviewed will be 
provided in a separate iSRC charter. 
Sentinel dosing will be applied. The first 2 participants in each cohort will receive either 
GZ21T or placebo as randomised. After the sentinel participants, at least 24 hours must pass 
before dosing of the remaining participants to give sufficient time for the observation of any 
reactions. 
An adaptive dosing strategy will be applied to allow for a flexible and safe dose escalation. 
The planned dose escalation is outlined in Section 8.3.2. The actual doses administered in 
each cohort will be guided by the iSRC recommendations based on the available safety, 
tolerability, and PK data, as described above. Every dose step is thus adjustable and the 
recommendation to the Sponsor may be to continue with a higher or lower dose than the 
planned dose, to repeat the same dose level, to continue with an intermediate dose level, or to 
stop dosing. 
The recommendations of the iSRC will be made in consensus between the iSRC members and 
documented as appropriate. In case of disagreement between the voting members, the most 
conservative approach will be taken. Repeating a dose level will not be allowed if any of the 
dose escalation-stopping criteria described in Section 8.3.4 have been met. 
The treatment code for individual participants may be requested to be broken by the iSRC 
voting members during the assessment process (partial unblinding) in accordance with the 
stopping criteria described in Section 8.3.4 to enable their decision on continued dosing of 
further cohorts or to stop the dose escalation. The medical staff will still be blinded for the 
treatments (active drug or placebo) to be administered in the subsequent cohorts in order to 
minimise bias. If unblinding was considered necessary, the iSRC meeting may consist of a 
closed part and an open part. 

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9 
TRIAL POPULATION 
Prospective approval of deviations from the eligibility criteria, also known as protocol 
waivers or exemptions, is not permitted. 
9.1 
Recruitment 
Participants will be recruited from CTC’s database of healthy volunteers, as well as from 
strategic marketing campaigns. Advertisements in social media and other media (newspapers, 
internet, radio, local distribution of flyers etc.) will be used to reach the target audience. The 
advertisement texts authorised by the Independent Ethics Committee (IEC) will be used to 
create all materials (digital, radio and/or print) for recruitment. 
9.2 
Screening and enrolment log 
Investigators must keep a record of all screened participants even if they were not 
subsequently included in the trial. This information is necessary to verify that participants 
were selected without bias. The reason for screening failure should be stated for all 
participants screened but not included. The reason for withdrawal should be stated for all 
participants who were included but did not complete the trial. 
A screening number generated automatically in the electronic case report form (eCRF) will be 
allocated to each participant in connection to the informed consent process at the screening 
visit (Visit 1). The screening number will allow the identification of participants irrespective 
of their possible eligibility for the trial. 
Eligible participants will be assigned a 3-digit randomisation number prior to the first IMP 
administration. For details, refer to Section 9.9. 
If a participant cannot receive the planned treatment with the IMP within 28 days after 
screening (i.e., the time interval between signing informed consent until the first 
administration of IMP) the participant should be rescreened before proceeding with the trial. 
9.3 
Number of participants 
Part A: Approximately, 64 potential participants will be screened to achieve 32 randomised 
participants (4 cohorts, 8 participants per cohort randomised in a 6:2 ratio). 
Part B: Approximately 18 potential particpants will be screened to achieve up to 9 included 
particpants. 
For the replacement of participants who discontinue the trial, see Section 9.8.3. 
9.4 
Inclusion criteria 
For inclusion in the trial, the participants must fulfil the following criteria: 
1. Willing and able to give written informed consent for participation in the trial. 
2. Healthy male or female participant aged 18 to 70 years, inclusive. 
3. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit. 
4. WOCBP must practice abstinence from heterosexual intercourse (only allowed when this 
is the preferred and usual lifestyle of the participant) or must agree to use a highly 
effective method of contraception with a failure rate of <1 % to prevent pregnancy from 
at least 2 weeks prior to the administration of IMP to 4 weeks after the last administration 
of IMP. 

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In addition, any male partner of a female participant must, unless he is sterile (e.g., has 
undergone vasectomy), agree to use a condom from the first administration of IMP until 
4 weeks after the last administration of IMP. 
The following are considered highly effective methods of contraception: 
• combined (oestrogen and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation (oral, intravaginal, transdermal), 
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, 
injectable, implantable), 
• intra-uterine device [IUD]or intra-uterine hormone-releasing system [IUS]). 
WOCBP must refrain from donating eggs from the first IMP administration until 3 months 
after the last IMP administration. 
Women of non-childbearing potential are pre-menopausal females who have undergone 
any of the following surgical procedures; hysterectomy, bilateral salpingectomy, or 
bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea 
(in questionable cases a blood sample with detection of follicle-stimulating hormone 
[FSH] >25 IU/L is confirmatory). 
Male participants, if not sterile (e.g., vasectomised), must be willing to use a condom or 
practice sexual abstinence from heterosexual intercourse (only allowed when this is the 
preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of 
a partner and refrain from donating sperm from the first administration of IMP until 3 
months after the last administration of IMP. Any female partner of a non-vasectomised 
male participant who is of childbearing potential must use contraceptive methods with a 
failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the 
first administration of IMP to 4 weeks after the last administration of IMP. 
9.5 
Exclusion criteria 
Participants must not enter the trial if any of the following exclusion criteria are fulfilled: 
1. History of any clinically significant disease or disorder which, in the opinion of the 
Investigator, may either put the participant at risk because of participation in the trial or 
influence the results or the participant’s ability to participate in the trial. 
2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks 
of the administration of IMP. 
3. Any clinically significant abnormalities regarding physical examination, vital signs, 
12- lead ECG, and laboratory values at the time of the screening visit, as judged by the 
Investigator. 
4. Malignancy within the past 5 years, including removal of basal cell carcinoma. 
5. Any planned major surgery within the duration of the trial. 
6. Any skin condition including tattoos that may limit the evaluation of e.g., local 
tolerability as judged by the Investigator. 
7. History of chronic urticaria, known history of urticaria triggered by specific factors or 
currently experiencing an episode of urticaria within the past 3 months. 
8. History of psoriasis, atopic eczema and similar conditions, as judged by the Investigator. 
9. Prescence of body hair or tattoos on the intended application areas, which in the opinion 
of the Investigator could interfere with local tolerability assessments. 

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10. Females who are pregnant, currently breastfeeding, or intend to become pregnant during 
the course of the trial. 
11. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B 
and C antibodies and/or human immunodeficiency virus (HIV). 
12. After 10 minutes of supine rest at the screening visit, any vital signs values outside the 
following ranges: 
- Systolic blood pressure: <90 or ≥140 mmHg, or 
- Diastolic blood pressure <50 or ≥90 mmHg, or 
- Pulse <40 or >90 bpm 
13. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant 
abnormalities in the resting ECG at the screening visit, as judged by the Investigator. 
14. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged 
by the Investigator, or history of hypersensitivity to drugs or food with a similar chemical 
structure or class to GZ21T. 
15. Regular use of any prescribed or non-prescribed medications, including antacids, 
analgesics, herbal remedies, within 2 weeks prior to the (first) administration of IMP, 
except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 
3000 mg/week), as well as nasal decongestants without cortisone, antihistamine, or 
anticholinergics for a maximum of 10 days, at the discretion of the Investigator. 
16. Unwillingness to abstain from the use of topical treatment (including but not limited to 
corticosteroids, calcineurin inhibitors, vitamin D analogues, and retinoids) at the 
application site within 1 week prior to Day 1 and from the use of moisturising ointment 
cream, emollients, oils (including shower oil) or sunscreen within 24 hours prior to Day 1 
until 1 week after IMP administration. 
17. Planned treatment or treatment with another investigational drug within 3 months prior to 
Day 1. Participants who consented and screened but were not dosed in previous clinical 
trials are not to be excluded. 
18. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, 
snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit. 
19. Positive screening result for drugs of abuse or alcohol at the screening visit or on 
admission to the trial site prior to the administration of the IMP. (Positive results that are 
expected given the participant’s medical history and prescribed medications can be 
disregarded as judged by the Investigator.) 
20. History of alcohol abuse or excessive intake of alcohol, history or presence of drug abuse 
including anabolic steroids, as judged by the Investigator 
21. Plasma donation within approximately 1 month of screening or blood donation (or 
corresponding blood loss) during the last 3 months prior to screening, at the discretion of 
the Investigator. 
22. The Investigator considers the participant unlikely to comply with trial procedures, 
restrictions and requirements. 

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9.6 
Restrictions during the trial 
Participants must be willing to comply with the restrictions as outlined in 9.6.1 and 9.6.2. 
9.6.1 
General restrictions 
1. Contraception requirements: Participants are expected to use contraceptive methods in 
accordance with inclusion criterion #4 or practice abstinence from heterosexual 
intercourse (only allowed when this is the preferred and usual lifestyle of the participant) 
during the clinical trial. 
2. Alcohol: Consumption of alcohol is not allowed within 48 hours prior to admittance to 
the trial site including the end-of-trial visit. 
3. Drugs of abuse: The use of drugs of abuse is not allowed from the screening visit to the 
end-of-trial visit. In addition to the urine drug screens described in the schedule of events, 
additional random testing can be performed at the site visits. 
4. Nicotine: Smoking or use of nicotine products (e.g., snuff, chewing tobacco) are not 
allowed from the screening visit to the end-of-trial visit. 
5. Exercise: The participants will be asked to abstain from strenuous exercise, defined as 
greater than 70% of the maximal pulse rate for ≥ 1 hour, for 48 hours prior to each trial 
visit. 
6. Blood donation: The participants must not donate blood or plasma from the screening 
visit until 3 months after the final medical examination at the end-of-trial visit. 
7. Participation in other clinical trials: The participants are not allowed to participate in any 
other interventional clinical trial from the screening visit until the end-of-trial visit. 
8. Leaving the trial clinic: Participants are not allowed to leave the trial site during trial 
visits unless authorised by the trial personnel. 
9. Moisturising creams: Participants must have abstained from using moisturising 
ointments, creams, or emollients (including shower oil and sunscreen) on the area to be 
treated for 24 hours prior to treatment on Day 1, until the end-of-trial visit. 
10. Showering: Participants must refrain from washing the treated area or taking a shower 
from the IMP administration until the 24-hour assessment on Day 2 (Part A). 
11. Sun protection: Protection from the sun is required from the IMP administration until the 
end-of-trial visit (Day 7). Participants are recommended to: 
o Stay in the shade, especially during the sun's peak hours of 10 AM to 4 PM. 
o Wear clothing that covers the treated skin area. 
o Abstain from the use of tanning beds. 
9.6.2 
Prior and concomitant therapy 
 
9.6.2.1 
Prohibited medications 
The regular use of any prescribed or non-prescribed medication within 2 weeks prior to the 
administration of IMP is not allowed, as judged by the Investigator. This includes antacids, 
analgesics and herbal remedies. 
Topical treatments are not allowed at the application site within 1 week prior to IMP 
administration. 

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The use of any prescribed or non-prescribed medication from the administration of IMP until 
the end-of-the trial visit will not be allowed except as detailed below. 
 
9.6.2.2 
Allowed medications 
• Paracetamol in doses up to 2000 mg/day for a maximum of 3 consecutive days. If this 
amount of paracetamol is insufficient for the treatment of the participant, withdrawal 
should be considered. 
• Nasal decongestants without cortisone, antihistamine, or anticholinergics for a maximum 
of 10 days. 
• Non-steroidal anti-inflammatory drugs (NSAIDs) intermittent use for dysmenorrhoea and 
dysmenorrhoea-associated symptoms, as judged by the Investigator. 
• Contraceptives, as defined in inclusion criterion #4. 
• Vitamins and minerals. 
As detailed in exclusion criterion #18, a positive drug-screen will exclude a participant from 
participation in the trial. However, positive results that are expected given the participant’s 
medical history and prescribed medications (e.g., opioid analgesics or attention deficit 
hyperactivity disorder [ADHD] medications) can be disregarded as judged by the 
Investigator. 
9.7 
Screen failures 
Screen failures are defined as participants who consent to participate in the clinical trial but do 
not fulfil all eligibility criteria and are not subsequently included in the trial. A minimal set of 
screen failure information is required to ensure transparent reporting of screen failure 
participants. Minimal information includes documentation of signed and dated informed 
consent form (ICF) and reason(s) for screening failure. 
Participants who do not meet the criteria for participation in this trial may be rescreened. 
Re-screening can be performed once if any of the following were reasons for screening failure 
or non-randomisation, as judged by the Investigator: 
• Practical reasons. 
• Non-significant medical conditions (e.g., influenza, nasopharyngitis). 
• Reserve participants not used in a previous group of participants. 
For participants who are rescreened, a new screening number will be assigned and a new, 
signed ICF must be collected. 
9.8 
Participant withdrawal 
9.8.1 
General withdrawal criteria 
Participants are free to voluntarily discontinue their participation in the trial, i.e., withdraw 
consent, at any time and for whatever reason without affecting their right to an appropriate 
follow-up investigation or their future care. If possible, the reason for withdrawal of consent 
should be documented in the eCRF. 
Participants may also be discontinued from the trial at any time at the discretion of the 
Investigator. 

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Reasons for discontinuation can include: 
• AE (as judged by the Investigator and/or Sponsor). 
• Death. 
• Logistical problem. 
• Lost to follow-up. 
• Non-compliance with study device. 
• Non-compliance with trial drug. 
• Non-compliance with trial schedule. 
• Physician decision. 
• Pregnancy. 
• Protocol deviation. 
• Technical problems. 
• Withdrawal of consent (participant decision). 
• Other. 
9.8.2 
Procedures for discontinuation of a participant from the trial 
A participant who prematurely discontinues participation in the trial will always be asked 
about the reason(s) for discontinuation and the presence of any AEs. If a participant 
withdraws consent, the Investigator must ask the participant if he/she is willing, as soon as 
possible, to be assessed according to the procedures scheduled for the end-of-trial visit. Any 
ongoing AEs will be followed up as described in Section 11.3.1.16. 
The primary reason for discontinuation/early withdrawal must be specified in the eCRF and 
final drug accountability must be performed. If the reason for discontinuation was an AE, the 
AE must be specified in the eCRF. 
9.8.3 
Participant replacement 
Participants who are prematurely withdrawn from the trial for any reason except the 
occurrence of AEs assessed as possibly or probably related to the trial treatment may be 
replaced. 
9.9 
Randomisation (Part A) 
On Day 1 (Visit 2), participants in each cohort will be randomised in a 6:2 ratio to receive 
either GZ21T or placebo. Sentinel dosing will be applied for the first 2 participants in each 
cohort who will receive either GZ21T or placebo as randomised. 
Randomisation will be performed in the EDC system, Viedoc™, employing static 
randomisation based on a computer-generated randomisation list generated using the 
statistical analysis software (SAS) Proc Plan (SAS version 9.4). The randomisation list will 
contain the participant number and treatment and will be kept by the randomiser in a sealed 
envelope until the database is locked. A copy of the randomisation list will be kept by an 
unblinded staff member at the site. 

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Sealed, individual treatment code envelopes will be kept in a locked and restricted area at the 
trial site for use in case of emergency unblinding. Code-breaking, if needed for iSRC 
evaluations or pharmacovigilance purposes (e.g., assessment of a potential suspected 
unexpected serious adverse reaction [SUSAR]), is also available for appointed persons 
through the eCRF. 
9.10 
Blinding 
Part A of the trial is double-blinded. The allocation of treatments will not be disclosed until 
clean file has been declared and the database has been locked. 
The IMP and the placebo are close to identical in appearance. The placebo will be masked in 
such a way that the participants and study staff will remain blinded during the trial. The 
unblinded person doing the IMP preparation will not be involved in any trial-specific 
assessments or evaluations. Details will be specified in a separate Blinding Plan. 
Part B of the trial is open-label and therefore no blinding will be performed. 
9.11 
Emergency unblinding during the trial 
The treatment code may only be broken by the Principal Investigator or a delegate in case of 
an emergency where knowledge of the treatment is necessary for proper medical management 
of the participant. The code-breaking procedure must be carefully documented. The site staff 
and the participants will still be blinded for the treatments (active treatment or placebo) to be 
administered to the subsequent participants in order to minimise bias. 
For unblinding procedures in case of a potential SUSAR, refer to Section 11.3.1.15 or in case 
of iSRC unblinding request, refer to Section 8.3.5. 

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10 
TRIAL TREATMENTS 
10.1 
Identity of investigational medicinal products 
GZ21T cream, 
. 
Placebo for GZ21T cream, 0 mg/g, 
. 
10.2 
Manufacturing, packaging, labelling and release 
All manufacturing, packaging, labelling and release of IMP will comply with applicable good 
manufacturing practice (GMP) requirements [12] and labelling requirements specified in 
Annex VI of Regulation European Union (EU) 536/2014 [13]. 
The manufacturer of the IMP is 
. The IMP will be packed, labelled, 
and released by 
 and shipped directly to the trial site (CTC, Uppsala, Sweden) by a 
good distribution practice (GDP) qualified courier. 
The unblinded site pharmacist/nurse at CTC holds the responsibility for receiving IMP 
deliveries, ensuring the maintenance of IMP quality during transportation, and validating that 
the IMP delivery aligns with the specifications outlined in the agreement with the Sponsor. 
Document verification, quality checks, storage condition confirmation, package integrity 
check and visual inspection of the IMP will be performed upon reception of the IMP in 
accordance with CTC’s standard operating procedures (SOPs). Any deviations identified 
during reception should be reported to the Sponsor and/or its representative as applicable. The 
confirmation of receipt will be sent by the site-responsible personnel to the clinical research 
assistant and/or the Sponsor. 
10.3 
Conditions for storage 
The IMP will be stored in an access-controlled storage area, restricted to unblinded site 
personnel, at CTC. The IMP will be stored at room temperature (15ºC – 25ºC). Automatic 
temperature logs are kept for all spaces where the IMP is stored. 
10.4 
Preparation and accountability 
IMP preparation will be done by trained personnel, i.e., a site pharmacist or a registered nurse, 
in a dedicated room at CTC. There will be 2 unblinded persons working together, 1 person 
will handle the IMP and perform the preparation according to the randomisation list and the 
other person will supervise the process. The preparation and administration of IMP doses will 
be conducted within the timeframe during which the IMP quality remains consistently upheld 
as outlined in the IMP Manual. 
CTC and the Investigator will maintain a storage and accountability log as well as a drug 
dispensing log detailing the dates and quantities of trial medication received, prepared for and 
used by each participant, as well as trial medication returned or destroyed at the end of the 
trial. Any discrepancies between prepared and returned IMP must be explained and 
documented. Products deliberately and/or accidentally destroyed by the trial site or the 
participant must be accounted for. 
10.5 
Treatment administration 
Participants will be administered a single dose of GZ21T or placebo as randomised and the 
area and application site will depend on the cohort. There are no fasting requirements prior to 
IMP application. 

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11 
TRIAL ASSESSMENTS 
The trial assessments are described in the sections below and the timing of assessments are 
detailed in the schedule of events (Table 8.1-1 and Table 8.1-2). 
11.1 
Recording of data 
The Principal Investigator will provide the Sponsor with all data produced during the trial 
from the scheduled assessments. They will ensure the accuracy, completeness, legibility, and 
timeliness of the data reported to the Sponsor in the eCRF and all required reports. 
It is important that PK blood sampling occurs as close as possible to the scheduled time. In 
order to achieve this, the timing priority order at a particular time point is: 
1. Blood samples for PK 
2. Vital signs 
3. Standard 12-lead safety ECG 
4. Local tolerability 
Safety laboratory samples will, for practical reasons, be taken in association with blood 
sampling for PK. 
Time points for PK blood sampling, safety laboratory samples, 12-lead ECG and vital signs 
are outlined in Table 8.1-1 and Table 8.1-2. The actual time for PK sampling must not deviate 
more than ±10% from the planned time. For further details regarding time windows for PK 
sampling, refer to Section 11.4.1. 
11.2 
Demographics and other baseline characteristics 
11.2.1 
Informed consent 
Signed informed consent must be obtained before any screening procedures are initiated. The 
informed consent procedure is further described in Section 14.3. 
11.2.2 
Eligibility criteria 
Eligibility criteria should be checked at the screening visit and verified before randomisation 
on Day 1. The criteria are specified in Sections 9.4 and 9.5. 
11.2.3 
Demographic information 
The following demographic data will be recorded: sex, age, ethnicity, and race. 
11.2.4 
Height, weight, and body mass index and body surface area 
Weight and height will be measured without shoes. BMI will be calculated, with 1 decimal, 
from the recorded height and weight. BSA will be calculated, with 2 decimals, from the 
recorded height and weight using a BSA conversion table. 
11.2.5 
Medical/surgical history 
Medical/surgical history will be obtained by participant interview in order to verify that the 
eligibility criteria are met. 
The medical/surgical history must include all relevant diseases and surgeries prior to the 
screening visit as judged by the Investigator. 

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11.2.6 
HIV and Hepatitis B/C 
Participants will be tested for HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen, hepatitis B 
virus surface antigen and hepatitis B and C virus antibodies prior to inclusion into the trial. 
Any positive result will exclude the participant from participating in the trial. 
11.2.7 
Pregnancy test 
All WOCBP will do a pregnancy test at the screening visit (blood/plasma) and visits specified 
in Table 8.1-1 and Table 8.1-3 (urine dipstick). 
11.2.8 
Urine drug-screen 
Urine will be screened for drugs of abuse at time points outlined in the schedule of events 
(Table 8.1-1 and Table 8.1-3) using the Drug-Screen Multi-15 Dip Test. Additional random 
tests can be performed during the trial period. 
11.2.9 
Alcohol test 
An alcohol test will be performed at time points outlined in the schedule of events (Table 
8.1-1 and Table 8.1-3). Additional random tests can be performed during the trial period. 
11.2.10 Baseline symptoms 
A baseline symptom is defined as an event that occurs between the participant’s signing of the 
ICF and the administration of IMP (i.e., an event that occurs during the screening period). 
Such events are not AEs and will be recorded as baseline symptoms in the AE log in the eCRF. 
11.2.11 Prior and concomitant medication 
Prior medications taken within 2 weeks prior to the first IMP administration will be obtained 
by participant interview in order to verify that the eligibility criteria are met (see also 
Section 9.6.2). 
Medications are classified as prior if the stop date was before or on the day of the dose 
administration (pre-dose) and as concomitant if ongoing on the day of the dose 
administration, stopped after the dose administration or started after the dose administration. 
To distinguish between prior and concomitant medications on Day 1 (i.e., the dosing day) the 
start time of any newly introduced medication or the stop time of any previously ongoing 
medication must be recorded in the eCRF. 
Any use of prior/concomitant medication from the screening visit until the last end-of-trial 
visit must be documented appropriately in the participant’s eCRF. 
Relevant information (i.e., name of medication, dose, dose form, unit, route, frequency, start 
and stop dates, reason for use) must be recorded. All changes in medication must be noted in 
the eCRF. 
11.3 
Assessments related to primary endpoints 
11.3.1 
Adverse events 
The Principal Investigator is responsible for ensuring that all medical staff involved in the 
trial is familiar with the content of this section and the content of the CTC SOPs regarding 
emergencies and Phase I trials. 
AEs will be handled in accordance with applicable regulations and guidelines [13,14]. 

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For the purpose of this trial, AEs will be assessed in relation to the IMP. 
 
11.3.1.1 
Definition of adverse event 
An AE is defined as any untoward medical occurrence in a participant to whom a medicinal 
product is administered, and which does not necessarily have a causal relationship with this 
treatment. 
An AE can be any unfavourable and unintended sign (including an abnormal laboratory 
finding), symptom or disease temporally associated with the use of a medicinal product, 
whether or not considered related to the medicinal product. 
 
11.3.1.2 
Definition of adverse reaction 
An AR is any noxious and unintended response to a medicinal product related to any dose of 
the product. 
The definition of an ARs implies a reasonable possibility of a causal relationship between the 
adverse event and the IMP. 
 
11.3.1.3 
Definition of serious adverse event 
A SAE is any untoward medical occurrence 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 patient 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 existing hospitalisation, 
• results in persistent or significant disability/incapacity, or 
• results in a congenital anomaly/birth defect. 
Medical and scientific judgement should be exercised in deciding whether expedited reporting 
is appropriate in other situations, such as "important medical events" that may not be 
immediately life-threatening or result in death or hospitalisation but may jeopardise the 
patient or may require intervention to prevent one of the other outcomes listed in the 
definition above. These should also usually be considered serious. 
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. 
 
11.3.1.4 
Definition of serious adverse reaction 
The term serious adverse reaction (SAR) is used whenever either the Investigator Sponsor or 
designee assesses that there is a reasonable possibility of a causal relationship between the 
SAE and the IMP. 

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11.3.1.5 
Definition of suspected unexpected serious adverse reaction 
A SAR, the nature, severity, or outcome of which is not consistent with the reference safety 
information (IB for an unapproved IMP, Summary of Product Characteristics for an approved 
medicinal product used in accordance with the terms of the marketing authorisation). 
 
11.3.1.6 
Time period and frequency for collecting adverse events 
All AEs (including SAEs) will be collected from the start of IMP administration until the end-
of-trial visit. 
Any AE with a start date on the day of the (first) IMP administration must be recorded with a 
start time. 
At the end-of-trial visit, information on new AEs or SAEs, if any, and stop dates for ongoing 
events must be recorded as applicable. 
Investigators will not be obliged to actively seek AEs or SAEs after the conclusion of the trial 
participation. However, if the Investigator learns of any SAE, including death, at any time 
after a participant has been discharged from the trial, and they consider the event to be 
reasonably related to the trial intervention or trial participation, the Investigator must 
promptly notify the Sponsor. 
 
11.3.1.7 
Collection of adverse events 
AEs identified using any of the following methods will be recorded: 
• AEs spontaneously reported by the participant. 
• AEs observed by the Investigator or medical personnel. 
• AEs elicited based on non-leading questions from the Investigator or medical personnel. 
 
11.3.1.8 
Recording of adverse events 
AEs must be recorded in the AE log of the eCRF. The Investigator must provide information 
on the AE, preferably as a diagnosis or at least as signs and symptoms; start and end dates, 
start and end time; intensity; causal relationship to IMP, action taken, and outcome. If the AE 
is serious, this must be indicated in the eCRF. 
AEs, including out-of-range clinically significant clinical safety laboratory values, must be 
recorded individually, except when considered manifestations of the same medical condition 
or disease state; in such cases, they must be recorded under a single diagnosis. 
 
11.3.1.9 
Assessment of seriousness 
The Investigator must assess and document the seriousness (serious or non-serious) of each 
AE using the definitions in Section 11.3.1.3. If the event is assessed as serious it must be 
reported as an SAE by the Investigator to the Sponsor according to Section 11.3.1.14. 
For the seriousness criteria of inpatient hospitalisation or prolongation of existing 
hospitalisation to be fulfilled, the AE requires at least an overnight admission (24 hours) or 
prolongs a hospitalisation beyond the expected length of stay. Emergency room visits that do 
not result in admission to the hospital should be evaluated for one of the other serious 
outcomes. 

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Planned hospitalisations or surgical interventions for a condition that existed before the 
participant signed the ICF, and that did not change in intensity, are not SAEs. 
If there is any doubt as to whether an AE meets the definition of an SAE, a conservative 
approach will be taken, and the AE will be reported as an SAE. 
 
11.3.1.10 Assessment of intensity 
The grading of the intensity of AEs will follow the CTCAE v5.0 [7]. Grade refers to the 
severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions 
of severity for each AE based on this general guideline. 
The Investigator must assess the intensity of an AE using the following definitions, and record 
it in the AE log of the eCRF: 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
Grade 2 
Moderate; minimal, local or non-invasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL)*. 
Grade 3 
Severe or medically significant but not immediately life-threatening; 
hospitalisation or prolongation of hospitalisation indicated; disabling; limiting 
self-care ADL**. 
Grade 4 
Life-threatening consequences: urgent intervention indicated. 
Grade 5 
Death related to AE. 
*Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Self-care ADL refers to bathing, dressing, undressing, feeding self, using the toilet, taking 
medications, and not being bedridden. 
 
11.3.1.11 Assessment of causal relationship 
The Investigator must assess the causal relationship between an AE and the use of the IMP, 
using the definitions below. Each assessment should be recorded in the AE log of the eCRF. 
Not related 
There is no evidence of causal relationship with the IMP. 
Unlikely related The event has little evidence of causal relationship to the IMP. 
Possible related The event has a suggestive causal relationship to the IMP, and an 
alternative aetiology is equally or less likely. 
Probable related The event has a strong causal relationship to the IMP or recurs on re-
challenge, and another aetiology is unlikely or significantly less likely. 
Definitely related The event is clearly related to the IMP. 
An AE is considered causally related to the use of the IMP when the causality assessment is 
probable or possible. 

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11.3.1.12 Outcome of adverse event 
The Investigator must assess the outcome of an AE using the definitions below and record it 
on the AE log of the eCRF. 
Recovered/resolved 
The participant has recovered completely, and no symptoms 
remain. 
Recovering/resolving 
The participant’s condition is improving, but symptoms remain. 
Recovered/resolved with 
sequelae 
 
Not recovered/not 
resolved 
Fatal 
Unknown 
The participant has recovered, but some symptoms remain (e.g., 
the participant had a stroke and is functioning normally, but has 
some motor impairment). 
The participant’s condition has not improved, and the symptoms 
are unchanged (e.g., atrial fibrillation has become chronic). 
 
11.3.1.13 Action taken with trial treatment 
The Investigator must document the action taken with trial treatment using the definitions 
below and record it on the AE log of the eCRF. 
Dose increased N/A 
Dose not changed 
Dose reduced N/A 
Drug interrupted 
Drug withdrawn N/A 
Not applicable 
Unknown 
11.3.1.14 Reporting of serious adverse events 
The Investigator must report SAEs within 24 hours of awareness to the Sponsor or its 
designee, this includes both initial information and any subsequent relevant/significant 
follow-up information to a previously reported SAE. 
The primary mechanism for reporting an SAE will be via the eCRF. When the Investigator 
classifies the event as “serious” in the eCRF, and signs off the event, an automatic e-mail alert 
is sent to the Sponsor or its designee, and any other predefined recipients. 
The backup procedure for reporting an SAE in case the eCRF is unavailable will be via the 
paper SAE form provided in the Investigator Site File (ISF). The Investigator must fill in the 
SAE form and send it Sponsor or its designee via secure file transfer. The trial site must notify 
the site, Monitor, via phone or e-mail about the submission of the SAE report. As soon as the 
site personnel have access to the eCRF, the SAE must be reported electronically as well. 
All available information regarding the SAE must be entered in the AE log for the specific 
participant, i.e., AE term, intensity, causality, outcome, seriousness criteria, action taken with 
the trial drug, and a narrative including the Investigator's rationale for the causality 
assessment. 

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The SAE report will be reviewed by the CTC’s Pharmacovigilance department to ensure that 
the report is valid. The Sponsor or its designee will acknowledge receipt of the SAE report to 
the reporting Investigator. For SAEs where important or relevant information is missing, 
follow-up queries to the site are raised promptly to keep the regulatory reporting timelines 
specified in Section 11.3.1.15. 
The Sponsor will perform an independent assessment of causality and provide a rationale for 
the assessment. The causality assessment given by the Investigator should not be downgraded 
by the Sponsor. If the Sponsor disagrees with the Investigator’s causality assessment, the 
opinion of both the Investigator and the Sponsor should be provided in the report. The 
Sponsor will perform an assessment of expectedness based on the applicable reference safety 
information (i.e., in the IB for GZ21T). 
If any additional information or documentation (e.g., autopsy report) on the SAE is required 
for the Sponsor’s assessment of the SAE, the Sponsor or its designee will request this 
information from the Investigator, and the Investigator is required to promptly respond to the 
request. 
Any subsequent relevant/significant follow-up information to a previously reported SAE must 
be entered in the AE log for the specific participant. If the Investigator makes any changes to 
the assessment of the case e.g., changes in seriousness, causality, or intensity, a justification 
for the change should be provided in the case narrative. If the SAE report in the eCRF is 
updated, a new automatic e-mail alert is sent to the Sponsor or its designee. 
Detailed information on the SAE handling and SUSAR reporting will be described in a trial-
specific safety management plan (SMP). 
 
11.3.1.15 Reporting of suspected unexpected serious adverse reactions 
An SAE will be classified as a SUSAR when either the Investigator Sponsor or designee 
assesses that there is a reasonable possibility of a causal relationship between the SAE and the 
IMP, and the Sponsor or designee assesses the event as unexpected based on the applicable 
reference safety information (i.e., in the IB/SmPC). 
Only SUSARs on which the treatment allocation of the participant is unblinded should be 
reported to the Member State. When an SAE may be a SUSAR, the blind will be broken by 
the Sponsor or its designee for the specific participant prior to reporting and a new assessment 
will be made to determine if the reporting rules for SUSAR apply. 
SAEs which are assessed by the Sponsor to be a SUSAR will be reported by the Sponsor or its 
designee to the EudraVigilance database and to the IEC (if required) in accordance with local 
regulations and timelines: 
• 7 calendar days if fatal or life-threatening. 
• 15 calendar days if non-fatal and non-life-threatening. 
The clock for expedited initial reporting (Day 0) starts as soon as the Sponsor or its designee, 
has received the information containing the minimum reporting criteria. The date will be 
documented on the acknowledgement receipt to the reporting Investigator. 
The Sponsor, or its designee, is responsible for informing the Investigator at the trial site of 
relevant information about potential SUSARs. Investigators should only receive blinded 
information unless unblinded information is judged necessary for safety reasons. 
Detailed information on the SAE handling and SUSAR reporting are described in a trial-
specific SMP. 

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11.3.1.16 Treatment and follow-up of adverse events 
Participants with AEs that occur during the trial must be treated according to daily clinical 
practice at the discretion of the Investigator. 
AEs must be followed up until resolution or to the end-of-trial visit, whichever comes first. At 
the end-of-trial visit, information on new AEs, if any, and stop dates for previously reported 
AEs must be recorded (if known). AEs assessed as stable by the Investigator at the end-of-
trial visit will not have to be followed up until resolution. 
It is the responsibility of the Investigator to follow-up on all SAEs until the participant has 
recovered, stabilised, or recovered with sequelae, and to report to the Sponsor all relevant new 
information using the same procedures and timelines as those for the initial report. Relevant 
information includes discharge summaries, autopsy reports, and medical consultations. 
 
11.3.1.17 Procedures in case of pregnancy 
In case of pregnancy or suspicion of possible pregnancy, the trial treatment must be stopped 
immediately, and the participant should be withdrawn from the trial. 
Pregnancy itself will not be regarded as an AE unless there is a suspicion that the IMP may 
have interfered with the effectiveness of the contraceptive medication. However, the outcome 
of all pregnancies (spontaneous miscarriage, elective termination, normal birth or congenital 
abnormality) must be followed up by the Investigator and the Sponsor and documented even 
after the participant was discontinued from the trial. 
All pregnancies must immediately be reported by the Investigator to the Sponsor or designee 
using the Pregnancy Report Form provided in the ISF. Once known, information on the 
outcome of the pregnancy must also be reported to the Sponsor or designee using the 
Pregnancy Report Form. 
All events of congenital abnormalities, birth defects and spontaneous miscarriages are SAEs 
and must be handled and reported as such as described in Section 11.3.1.14. 
Pregnancies in female partners of male trial participants should also be followed according to 
the procedures described above. 
 
11.3.1.18 Medication errors and uses outside what is foreseen in the protocol 
A medication error is an unintended failure in the drug treatment process that leads to or has 
the potential to lead to, harm to the participant. 
Medication errors and uses outside what is foreseen in this protocol, including misuse and 
abuse of the product, will be reported in the participant’s medical records, and documented in 
the protocol deviation (PD) log. Any medication error, misuse and/or abuse of the drug 
product will also be recorded in the AE log of the eCRF (refer to Section 11.3.1.8). 
 
11.3.1.19 Treatment of overdose 
An overdose is a dose in excess of the dose specified for each cohort in this CTP. 
Overdosing is not likely to occur in this trial since all IMP will be administered by site 
personnel under medical surveillance. In cases of accidental overdose, standard supportive 
measures will be adopted as required. 
Overdoses must be documented in the eCRF. An overdose with associated AE will be 
recorded as the AE diagnosis/symptoms in the AE log of the eCRF. 

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An overdose without associated symptoms will only be reported in the participant’s medical 
records and documented in the PD log. 
No known antidotes are available in case of overdose with GZ21T. 
There have been no reported cases of GZ21T overdose. 
11.3.2 
Local tolerability 
The Investigator will assess the incidence of local tolerability reactions of the administration 
site by direct inspection at visits and timepoints specified in Table 8.1-1 and Table 8.1-2 for 
Part A and in Table 8.1-3 for Part B. The assessment will include the Investigator’s (or 
delegate’s) evaluation of erythema, swelling, pruritus, burning and discoloration and dryness. 
The presence/absence and intensity of local tolerability reactions at each time point will be 
recorded in a local tolerability module of the eCRF. Assessment of intensity will be 
performed as follows: 
• Local tolerability reactions will be assessed by the Investigator or delegate as non, mild, 
moderate, or severe based on the definition of the reaction as outlined in Table 11.3-1. 
Discoloration is defined as change in skin tone other than erythema, e.g., increased 
pigmentation or blanching, other than colour from the IMP. The intensity of each reaction 
will be documented in the eCRF. 
Local tolerability reactions will be recorded as IMP-related AEs in the AE Log of the eCRF 
as follows: 
• Erythema, swelling, pruritus, burning, blistering and urticaria: Grade 2 (moderate) and 
Grade 3 (severe) reactions OR Grade 1 if present ≥ 24 hours after the start of IMP 
application. 
• Dryness and discoloration: Grade 2 (moderate) and Grade 3 (severe) reactions. 
As for other AEs, the full duration of the reaction(s), and the highest recorded intensity per 
reaction, should be entered. 

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Table 11.3-1 Local tolerability evaluation scale 
Reaction 
None=0 
Mild=1 
Moderate=2 
Severe=3 
Erythema 
No detectable 
erythema; skin of 
normal colour 
Slight pinkness present 
Definite redness, 
easily recognised 
Intense redness 
Swelling 
No swelling 
Mild 
Moderate 
Severe 
Pruritus 
No pruritus 
Occasional, slight 
itching/scratching 
Constant or 
intermittent 
itching/scratching 
that is not disturbing 
sleep 
Bothersome 
itching/scratching that 
is disturbing sleep 
Burning 
No burning 
Slight warm, tingling 
sensation; not really 
bothersome 
Definite warm, 
tingling sensation 
that is somewhat 
bothersome 
Hot, tingling/stinging 
sensation that has 
caused definite 
discomfort 
Blistering 
None 
Discrete signs 
Moderate 
Severe 
Urticaria 
None 
Discrete signs 
Moderate 
Severe 
Discoloration 
None 
Mild 
Moderate 
Severe 
Dryness 
None 
Mild 
Moderate 
Severe 
11.3.3 
Vital signs 
Systolic and diastolic blood pressure and pulse will be measured in a supine position after 
10 minutes of rest. 
Any vital signs outside of normal ranges will be judged as clinically significant or not 
clinically significant. The assessment will be recorded in the eCRF. Abnormal post-IMP 
administration findings assessed by the Investigator as clinically significant will be reported 
as AEs. 
11.3.4 
Electrocardiogram 
Single 12-lead ECGs will be recorded in a supine position after 10 minutes of rest using an 
ECG machine. The resting heart rate and PQ/PR, QRS, QT and QTcF intervals will be 
recorded. 
Safety ECGs will be reviewed and interpreted onsite by the Investigator. 
Any abnormalities will be specified and documented as clinically significant or not clinically 
significant. Abnormal post-IMP administration findings assessed by the Investigator as 
clinically significant will be reported as AEs. 
11.3.5 
Safety laboratory assessments 
Blood samples for the analysis of clinical chemistry, haematology and coagulation parameters 
will be collected through venepuncture or an indwelling venous catheter and sent to the 
certified clinical chemistry laboratory at Uppsala University Hospital, Sweden, and analysed 
by routine analytical methods. 
The safety laboratory parameters are defined in Table 11.3-2 and will be assessed at visits and 
time points specified in Table 8.1-1. 

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Any laboratory values outside of normal ranges will be specified and documented as normal, 
abnormal not clinically significant, or abnormal clinically significant in the eCRF. Abnormal 
values assessed by the Investigator as clinically significant will be reported as AEs. If an 
abnormal value is associated with corresponding clinical signs or symptoms, the 
sign/symptom should be reported as the AE. 
Table 11.3-2 Safety laboratory parameters 
 
Category 
Parameter 
 
Clinical chemistry 
Alanine aminotransferase (ALT) 
Albumin 
Alkaline phosphatase (ALP) 
Aspartate aminotransferase (AST) 
Bilirubin (total and conjugated) 
Calcium 
Creatinine (estimated glomerular filtration rate [eGFR] included) 
Glucose 
Phosphate 
Potassium 
Sodium 
Urea 
Haematology 
Erythrocyte count 
Leukocyte count with differential count 
Haematocrit (B-EVF) 
Haemoglobin (Hb) 
Mean corpuscular volume (MCV) 
Mean corpuscular haemoglobin (MCH) 
Platelet count 
Coagulation 
Activated Partial Thromboplastin Time (APTT) 
Prothrombin Complex International Normalised Ratio (PK[INR]) 
Follicle-stimulating 
hormone (FSH) test 
Pregnancy test (WOCBP 
only) 
FSH (at the screening visit, females only for confirmation of menopause) 
 
Plasma pregnancy (human chorionic gonadotropin [hCG]) test at screening 
Urine pregnancy test 
 
11.3.6 
Physical examinations 
A complete physical examination will be performed at the screening visit and will include 
assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, 
cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. 
A symptom-directed physical examination will be performed at Day 1 pre-dose and at the 
follow-up visits and will only be performed on the organ systems which are warranted, e.g., 
when the participant has indicated any problems with the affected system or for which the 
Investigator or site nurse has reason to believe there may be a problem with the affected organ 
system. 
Any abnormalities will be specified and documented as clinically significant or not clinically 
significant. Abnormal post-IMP administration findings assessed by the Investigator as 
clinically significant will be reported as AEs. 

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11.3.7 
Cream absorption evaluation (Part B) 
The cream absorption will be documented by photography of the administered area at 
timepoints specified in Table 8.1-4. 
In addition, the cream absorption will be assessed at 30 minutes, 1 hour, and 2 hours post-
administration on a 4-point scale scale: 
“1= not absorbed”; “2= somewhat absorbed”; “3= mostly absorbed”; “4= completely 
absorbed” 
The time until adequate abruption will be measured up to 2 hours after administration. 
The Sponsor and the Investigator will determine if more cohorts will be explored at a higher 
or lower dose in order to reach the optimal dose/area or if the abosorption is sufficient. 
11.4 
Assessments related to secondary endpoints 
11.4.1 
Pharmacokinetic sampling and analysis (Part A) 
Venous blood samples (approximately 4 mL) for the determination of plasma concentrations 
and PK characterisation of GZ21T after administration of the IMP, will be collected through 
an indwelling venous catheter or by venepuncture at the pre-specified visits and time-points 
detailed in Table 8.1-1 and Table 8.1-2. 
The actual time for blood PK sampling must not deviate more than ±10% from the planned 
time. The pre-dose PK sample may be taken within 60 minutes prior to dosing. 
The date and time of collection of each sample will be recorded in the eCRF. 
The blood samples will be collected in pre-labelled tubes. All the collected blood samples will 
be diluted in acetonitrile, mixed using a vortex mixer and frozen at ≤ -80°C until shipment. 
Further details will be described in a separate laboratory manual. 
Plasma samples for determination of plasma concentrations of GZ21T will be analysed by 
Scantox, Gothenburg, Sweden, by means of a validated liquid chromatography-tandem mass 
spectrometry (LC-MS/MS) method. The details of the analytical method used will be 
described in a separate bioanalytical report. 
11.5 
Appropriateness of measurements 
All methods used are commonly used in standard medical care and in Phase I clinical trials. 
Non-compartmental analysis of PK parameters is standard for Phase I clinical trials. 

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12 
PROCEDURES FOR BIOLOGICAL SAMPLES 
12.1 
Sample collection 
The sample collection procedure for PK analysis is described in Section 11.4.1. 
Blood samples are collected according to standard procedures. 
12.2 
Volume of blood 
The anticipated volume of blood samples collected during the trial from each participant will 
be approximately 132 mL in Part A and 24 mL in Part B (Table 12.2-1 and Table 12.2-2, 
respectively). For reference, a regular blood donation consists of between 350 mL to 450 mL 
(±10 %) for persons weighing at least 45-50 kg [15]. 
Table 12.2-1 Estimated blood volumes (Part A) 
 
Assessment 
Estimated number of 
sampling occasions 
Estimated volume 
per occasion (mL) 
Total (mL) 
PK blood sampling 
12 
4 mL 
48 mL 
HIV, Hepatitis B/C 
1 
4 mL 
4 mL 
Clinical chemistry, haematology, coagulation 
4 
20 mL 
Total: 
80 mL 
132 mL 
 
Table 12.2-2 Estimated blood volumes (Part B) 
Assessment 
Estimated number of 
sampling occasions 
 
 
Estimated volume 
per occasion (mL) 
 
 
Total (mL) 
 
 
HIV, Hepatitis B/C 
1 
4 mL 
4 mL 
Clinical chemistry, haematology, coagulation 
1 
20 mL 
20 mL 
Total: 
24 mL 
 
12.3 
Handling, storage and destruction of laboratory samples 
All biological samples will be registered in a biobank at CTC (Swedish Health and Social 
Care Inspectorate biobank registry number 893). 
Any remains from the safety laboratory samples will be disposed of after analyses. 
The samples for analyses of PK parameters will be stored at ≤ -80°C until analysed. The 
samples will be disposed of after the clinical trial report (CTR) has been finalised. 
12.4 
Chain of custody of biological samples 
A full chain of custody is maintained for all samples throughout their life-cycle. 
CTC keeps full traceability of collected biological samples from the trial participants while in 
storage at the trial site until shipment and keeps documentation of receipt of arrival. The 
sample receiver (the analytical laboratory) will keep full traceability of the samples while in 
their storage and during use until used or disposed of. 
The Sponsor will keep oversight of the entire life-cycle of the samples through internal 
procedures, monitoring of the trial site and auditing of external laboratory providers. 

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12.5 
Withdrawal of informed consent for donated biological samples 
If a participant withdraws consent to the use of biological samples donated, the samples will 
be disposed of/destroyed, if not already analysed and documented. 
The Principal Investigator will ensure that: 
• Participant withdrawal of consent is notified immediately to the Sponsor. 
• Biological samples from the participant, if stored at the trial site, are immediately 
identified, disposed of/destroyed and the action is documented. 
The Sponsor will ensure that the laboratory holding the samples is informed about the 
withdrawn consent immediately that samples are disposed of/destroyed or returned to the trial 
site and the action is documented. 

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13 
QUALITY MANAGEMENT, QUALITY ASSURANCE AND QUALITY 
CONTROL 
13.1 
Quality management: critical process, system, and data identification 
During CTP development, the Sponsor will identify those processes, systems (facilities, 
computerised systems) and data that are critical to ensure human subject protection and the 
reliability of trial results according to applicable SOPs and the ICH E6(R2) guideline [16]. 
Identified risks will be categorised separately from the CTP. 
13.2 
Quality assurance and quality control 
The Sponsor has delegated the responsibilities outlined below to CTC while maintaining 
overall trial oversight: 
• Implementing and maintaining quality assurance (QA) and quality control (QC) systems 
with written SOPs with regard to the management of identified risks, CTP compliance, 
good clinical practice (GCP) compliance and applicable regulatory requirements. 
• Securing agreements with involved subcontractors and performing regular subcontractor 
oversight to ensure CTP compliance, GCP compliance and compliance with applicable 
regulatory requirements. 
• Implementing a risk-based validated EDC system and maintaining SOPs for the whole 
life-cycle of the system. 
• QC application to each stage of data handling to ensure that all data are reliable and have 
been processed correctly. 

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14 
ETHICAL AND REGULATORY REQUIREMENTS 
14.1 
Ethical conduct of the trial 
The trial will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki [17] and are consistent with the ICH E6 (R2) guideline for GCP [16], 
Regulation (EU) 536/2014 [13], and applicable local regulatory requirements. 
14.2 
Ethics and regulatory review 
The Principal Investigator is responsible for submission of the CTP, the participant 
information and ICF any other written information to be provided to the participants and any 
advertisements used for recruitment of participants to applicable IEC for authorisation. 
The Sponsor has delegated to CTC the responsibility to submit trial documents to the 
applicable Member State according to local regulatory requirements. 
Authorisation must be obtained in writing from both the IEC and Member State before the 
first participant can be recruited. 
The Sponsor will provide the Member State, IEC, and Principal Investigator with safety 
updates/reports according to local requirements. Progress reports and notifications of 
SUSARs will be provided to the IEC according to local regulations and guidelines. 
14.3 
Participant information and consent 
It is the responsibility of the Investigator or an authorised associate to give each potential trial 
participant adequate verbal and written information before any trial-specific assessments are 
performed. 
The information will include the nature, objectives, benefits, implications, risks and 
inconveniencies of the trial, as well as the conditions under which the trial is to be conducted 
and the expected duration of the participant’s participation. It will be emphasised that 
participation in the trial is voluntary and that the participant may withdraw from participation 
at any time and for any reason, without any detriment and without having to provide any 
justification. All participants will be given the opportunity to ask questions about the trial and 
will be given sufficient time to consider participation before signing the ICF. 
Before performing any trial-related procedures the ICF must be signed and personally dated 
by the participant and by the Investigator. A copy of the participant information including the 
signed ICF will be provided to the participant. 
Documentation of the discussion and the date of informed consent must be recorded in the 
source documentation and the eCRF. The participant information and the signed ICF should 
be filed by the Investigator for possible future audits and/or inspections. 
The final authorised version of the participant information and ICF must not be changed 
without authorisation from the Sponsor and the applicable IEC. 
14.4 
Participant information card 
The participant will be provided with a participant information card including the following 
information: 
• That they are participating in a clinical trial. 
• Participant trial ID. 
• That they are treated with the IMP. 

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• The name and phone number of the Investigator. 
• The name and address of the Sponsor. 
14.5 
Participant privacy and data protection 
The clinical personnel affirm and uphold the principle of the participant’s right to privacy 
during and after the trial. 
The ICF includes information that data will be recorded, collected and processed and 
information related to potential transfer to European Economic Area (EEA) or non-EEA 
countries. In accordance with the General Data Protection Regulation (GDPR [EU] 2016/679) 
[18], these pseudo-anonymised data will not identify any persons taking part in the trial. If 
any part of the data, including biological samples, is handled by any other organisation, inside 
or outside the EU, appropriate agreements, setting out each one's respective roles and 
responsibilities, and how individuals may exercise their rights in respect of the data other 
documentation, such as transfer agreement, will be established, and verification of 
organisation quality and process systems will take place to ensure that the data processing is 
performed in accordance with the provisions of the GDPR and other relevant legislation 
before any data transfer takes place. 
The potential participant should be informed that by signing the ICF they approve that 
authorised representatives from the Sponsor and CTC, as well as the concerned IEC and 
competent authority, have direct access to their medical records for verification of clinical 
trial procedures. For further details on the participant information and ICF process, refer to 
Section 14.3. 
The participant has the right to request access to their personal data and the right to request 
rectification of any data that is not correct and/or complete in accordance with GDPR [18] and 
the request will be raised to the Principal Investigator. 
The Investigator must file a participant identification list which includes sufficient 
information to link records, i.e., the eCRF and clinical records. This list must be preserved for 
possible future inspections/audits but must not be made available to the Sponsor except for 
monitoring or auditing purposes. 
Personal data that are collected in the trial such as health information and ethnicity are 
considered as sensitive personal data. This data will be pseudo-anonymised, i.e., personally 
identifiable information (PII) will be removed and replaced by a unique participant ID and 
will be processed by the Sponsor and other involved parties during the trial. After the trial 
ends, only pseudo-anonymised data can be used, i.e., aggregated data sets can be used. 
For this trial, the Sponsor is the data controller of all data processed during the trial (e.g., trial 
master file [TMF], trial reports) and CTC is the data processor. Any subcontractors used in 
the trial are also data processors. 
For data that are processed at the clinic (e.g., medical records and ISF), CTC is the data 
controller. 

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14.6 
Data security breach 
In order to avoid or minimise data security breaches, organisational, physical and 
technological security measures with a risk-based approach have been taken for all computer 
systems used to process data and personal data in this trial. 
In the event of a data security breach, the controller (the Sponsor for trial data and the trial site 
for medical data): 
• documents any personal data breaches, comprising the facts relating to the personal data 
breach, its effects and the remedial action taken. 
• notifies the personal data breach supervisory authority, unless the data breach is unlikely 
to result in a risk to the rights and freedoms of natural persons. 
• communicates the personal data breach to the data subject when the personal data breach 
is likely to result in a high risk to the rights and freedoms of natural persons. 
14.7 
Changes to the authorised clinical trial protocol 
Any proposed change to the authorised final CTP, including appendices, will be documented 
in a written and numbered clinical protocol modification form. All substantial modifications 
to the protocol must be authorised according to applicable regulations before implementation. 
14.8 
Audits and regulatory inspections 
Authorised representatives of the Sponsor, a regulatory authority, or an IEC may perform 
audits or regulatory inspections at the trial site, including source data verification (SDV). The 
purpose of an audit or inspection is to systematically and independently examine all 
investigation-related activities and documents, to determine whether these activities were 
conducted and whether data were recorded, analysed, and accurately reported according to the 
CTP, ICH-GCP guidelines and any applicable regulatory requirements. The Investigator will 
contact the Sponsor immediately if contacted by a Member State about an inspection at the 
trial site. 
This trial may be subject to internal or external monitoring, auditing, or inspection procedures 
to ensure adherence to GCP. Access to all trial-related documents including direct access to 
source data will be given at that time. 
14.9 
Insurance 
Participants will be covered under the Sponsor’s liability insurance policy through Acord. The 
certificate of insurance and an information leaflet containing essential information about the 
insurance coverage can be provided upon request. The participating participants are also 
protected in accordance with national regulations, as applicable. 
CTC has a company insurance covering services performed by CTC. 

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15 
TRIAL MANAGEMENT 
15.1 
Training of trial site personnel 
Before the inclusion of the first trial participant, a Sponsor representative or delegate will 
perform a site initiation visit at the trial site. The requirements of the CTP and related 
documents will be reviewed and discussed, and the investigational staff will be trained in any 
trial-specific procedures and system(s) utilised. 
It is the responsibility of the Investigator to ensure that all personnel involved in the trial are 
fully informed of all relevant aspects of the trial and have a detailed knowledge of and 
training in the procedures that are to be executed by them. Any new information of relevance 
to the performance of this trial must be forwarded to the staff involved in a timely manner. 
The Investigator will keep a list of all personnel involved in the trial together with their 
function and trial-related duties delegated. A Curriculum Vitae will be available for all staff 
delegated trial-specific duties. 
15.2 
Clinical monitoring 
The Sponsor is responsible for securing agreement from all involved parties to ensure direct 
access to the participating site, source data/documents, and reports for monitoring and 
auditing by the Sponsor, and inspection by domestic and foreign regulatory authorities. The 
extent and nature of the monitoring shall be determined by the Sponsor based on an 
assessment that takes into consideration all characteristics of the clinical trial. 
As defined in the risk-based monitoring (RBM) plan, approved by the Sponsor, and provided 
separately, the responsible Monitor will periodically visit the trial site at times agreed upon by 
the Investigator and the Monitor. At each monitoring visit, the role of the Monitor is (but not 
limited to) the following: 
• provide information and support to the investigational team. 
• confirm that facilities and resources remain acceptable. 
• confirm that the investigational team is adhering to the CTP, applicable SOPs, guidelines, 
manuals, and regulatory requirements. 
• verify that data are being accurately and timely recorded in the eCRFs and that IMP 
accountability checks are being performed. 
• verify that data in the eCRF are consistent with the clinical records (SDV) in accordance 
with the RBM plan. 
• verify that the correct informed consent procedure has been adhered to for participating 
participants. 
• ensure that withdrawal of informed consent to the use of the participant’s biological 
samples will be reported and biological samples are identified and disposed of/destructed 
accordingly, and that this action is documented and reported to the participant. 
• verify that AEs are recorded and reported in a timely manner and according to the CTP. 
• raise and escalate any serious quality issues, serious GCP breaches and any data privacy 
breaches to the Sponsor. 
Centralised monitoring will also be performed continuously by project team members at CTC 
in accordance with the RBM plan. When the trial has been completed, all queries have been 
resolved and the database has been locked, the Monitor will perform a close-out visit. 

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15.3 
Source data documents 
A separate origin of source data list will be generated before the start of enrolment, specifying 
the location of the source of derived information appearing in the eCRF. This document must 
be signed by the Principal Investigator and the Monitor to confirm the agreement before the 
start of recruitment. 
Source documents are all documents used by the Investigator or hospital that relate to the 
participant’s medical history, and that verify the existence of the participant, the inclusion and 
exclusion criteria, and all records covering the participant’s participation in the trial. They 
include laboratory notes, memoranda, material dispensing records, participant files, etc. The 
eCRF may constitute source data if clearly defined in the origin of the source data list. 
The Investigator must guarantee access to source documents to the Monitor, CAs and the 
IECs if required. 
15.4 
Trial agreements 
This trial is fully financed by the Sponsor, Ankh Life Sciences Limited. The management and 
conduct of the clinical trial have been outsourced to the contract research organisation (CRO), 
CTC. The Principal Investigator is an employee of CTC. 
The agreements between the Sponsor and CTC must be in place before any trial-related 
procedures can take place, or participants be enrolled. 
The Sponsor and CRO responsibility and duty split is regulated in a separate clinical trial 
agreement. 
The Principal Investigator must comply with all the terms, conditions, and obligations of the 
clinical trial agreement for this clinical trial. The participants will be compensated for the time 
spent participating in the trial. Travel expenses and/or loss of income will be reimbursed. 
15.5 
Trial timetable and end-of-trial 
The trial is expected to start in Q2 2024 and to be completed by Q1 2025. 
The start of the clinical trial is defined as the date of the first participant’s first visit. 
The Sponsor will notify each Member State of the start of a clinical trial (through the Clinical 
Trials Information System [CTIS]) within 15 days from the start of the clinical trial. 
A participant is considered to have completed the trial if they have completed all visits in the 
trial including the end-of-trial visit. 
The end of the trial is defined as the date of the last visit of the last participant in the trial. 
The Sponsor will notify each Member State of the end of the recruitment of participants for a 
clinical trial (through CTIS) within 15 days of the last participant’s first visit. 
The Sponsor shall notify each Member State of the end of the trial (through CTIS) within 
15 days of the last participant’s last visit. 
15.6 
Temporary halt or Early termination of the trial 
The Investigator or the Sponsor may temporarily halt or terminate this trial prematurely for 
any reasonable cause. 
A temporary halt for reasons not affecting the benefit-risk balance of the trial should be 
notified to the Member States concerned through CTIS within 15 days of the temporary halt. 
When the trial is resumed, a new notification should be sent within 15 days of the restart. 

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A temporary halt or early termination of a trial for reasons that change the benefit-risk balance 
(e.g., safety reasons) should be notified to the concerned Member States through CTIS 
without undue delay, but no later than 15 days from the halt or termination. The reasons for 
the halt/termination and specific follow-up measures should be stated. 
The restart of a trial following a temporary halt for reasons that change the benefit-risk 
balance requires authorisation of a substantial modification to the trial, see Section 14.7. 
Conditions that may warrant trial termination include, but are not limited to the following: 
• There is sufficient ground that continuation of the trial will jeopardise participant health 
or safety. 
• A decision by the Sponsor to suspend or discontinue the development of the IMP. 
If the Member State obtains information that raises doubts about the safety or scientific 
validity of the trial, the Member State may also revoke the authorisation for, suspend, or 
require the Sponsor to modify aspects of the trial. 
If the trial is prematurely terminated or suspended for any reason, the Investigator/institution 
must promptly inform the trial participants and must ensure appropriate follow-up for the 
participants. 
15.7 
Reporting of serious breach 
The Sponsor will notify the Member States concerned about a serious breach of the 
Regulation or of the version of the protocol applicable at the time of the breach through CTIS 
without undue delay but not later than 7 days of becoming aware of that breach. 
15.8 
Reporting of urgent safety measures 
The Sponsor will notify, without delay but no later than 7 days from the date measures have 
been taken, each Member State is concerned about an urgent safety measure and the measures 
taken. 
15.9 
Reporting and publication 
15.9.1 
Registration in a publicly accessible database 
The clinical trial will be registered in a publicly accessible and free-of-charge database (EU 
Clinical Trials Registry via CTIS) which is a primary or partner registry of, or a data provider 
to, the WHO International Clinical Trials Registry Platform (ICTRP) prior to first recruitment 
of any participants. 
15.9.2 
Public disclosure 
Public disclosure of Sponsor and Member State documents and data (except data and 
documents related to quality) in the public database of CTIS takes place at the time of the 
decision by the Member State unless the Sponsor requests for a deferral of the public 
disclosure at the initial application when registering the clinical trial in CTIS. 
The deferral for this trial will be according to the default time allowed for Category 1. No 
deferral is possible for the main characteristics of the clinical trial, conclusion part I, 
conclusion part II, outcome, and date of decision on clinical trial, start and end dates and 
temporary halt. 

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15.9.3 
Summary of results and clinical trial report 
A summary of the results of the trial accompanied by a layperson's summary of results will be 
submitted to the EU database within one year from the end of a clinical trial in all Member 
States concerned. 
After completion of the trial, an ICH E3 [19] guideline-compliant CTR describing the conduct 
of the trial, and the results obtained will be prepared by the Sponsor or their designee. The 
CTR will be reviewed and approved by, as a minimum, the Principal Investigator, and the 
Sponsor. 
Where the clinical trial was intended to be used for obtaining a marketing authorisation for the 
IMP, the applicant for the marketing authorisation shall submit to the EU database CTIS the 
CTR within 30 days after the day the marketing authorisation has been granted, the procedure 
for granting the marketing authorisation has been completed, or the applicant for the 
marketing authorisation has withdrawn the application. 
15.9.4 
Annual safety report 
If the trial duration exceeds 1 year, the Sponsor must submit an annual safety report to the 
applicable Member States. The report must summarise all pertinent safety information 
collected during the reporting period and contain an update of the risk-benefit evaluation if 
there has been any change since the authorisation of the clinical trial. 
15.9.5 
Confidentiality and ownership of trial data 
Any confidential information relating to the IMP or the trial, including any data and results 
from the trial, will be the exclusive property of the Sponsor. The Investigator and any other 
persons involved in the trial are responsible for protecting the confidentiality of this 
proprietary information. 
15.9.6 
Publication 
The results from this trial may be submitted for publication at the discretion of the Sponsor. 
15.10 
Archiving 
The Sponsor will archive the content of the clinical TMF for at least 25 years after the end of 
the clinical trial [13]. The content of the clinical TMF shall be archived in a way that ensures 
that it is readily available and accessible, upon request. 
Medical files of participants shall be archived in accordance with national law. 
The data from the eCRFs will be sent to the Sponsor and a copy will be sent to the site and 
filed in the ISF for archiving for 25 years after finalisation of the CTR. The ISF will also 
include any original source documents related to the trial, the participant identification list 
(providing the sole link between named participant source records and pseudonymous eCRF 
data) and the original signed ICFs. It is the responsibility of the Sponsor to inform the 
Investigator/institution as to when these documents no longer need to be retained. 
The completed original eCRFs are the sole property of the Sponsor and must not be made 
available in any form to third parties, except for authorised representatives of appropriate 
health/regulatory authorities, without written permission from the Sponsor. 

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16 
DATA MANAGEMENT 
The data management routines include procedures for handling the eCRF, database setup and 
management, data entry and verification, data validation, QC of the database, and 
documentation of the performed activities including information on discrepancies in the 
process. The database, data entry screens and programme will be designed in accordance with 
the CTP. 
Data validation/data cleaning procedures are designed to assure the validity and accuracy of 
clinical data. These procedures consist of computerised online edit checks identifying e.g., 
data values that are outside the allowed range and SAS-programmed batch checks on data 
exports. All trial-specific and standard data validation programming will be tested prior to 
being used on the final data. 
Detailed information on data management will be described in a trial-specific Data 
Management Plan (DMP). 
16.1 
The web-based eCRF 
Clinical data will be entered into a 21 CFR Part 11-compliant eCRF (Viedoc™) provided by 
Viedoc Technologies AB. The eCRF includes password protection and internal quality 
checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, 
or inaccurate. Clinical data will be entered directly from the source documents or at the 
bedside (if the eCRF data constitutes source data). Source data are to be defined at the site 
before the inclusion of the first participant (Section 15.3). 
Authorised site personnel designated by the Investigator will complete data collection. 
Appropriate training and security measures will be completed with the Investigator and all 
authorised trial site personnel prior to the trial being initiated and any data being entered into 
the system for any trial participant. 
16.2 
The entering of data into the eCRF 
All entries, corrections, and alterations are to be made by the Investigator or designee. Neither 
the Monitor nor any other project team member besides site staff can enter data in the eCRF. 
All data should be entered in English. The eCRFs should be completed as soon as possible 
during or after the participant’s visit. To avoid inter-observer variability, every effort should 
be made to ensure that preferably the same individual who made the initial baseline 
determinations completes all corresponding follow-up evaluations. The Investigator must 
verify that all data entries in the eCRFs are accurate and correct. If some assessments are not 
done, or if certain information is not available, not applicable, or unknown, the Investigator or 
assigned clinical staff will record such information in the eCRF. The Investigator will be 
required to electronically sign off on the clinical data. This will be performed by means of the 
Investigator’s unique User ID and password; date and time stamps will be added 
automatically at the time of electronic signature. 
16.3 
The query process 
The Monitor will review the eCRFs and evaluate them for completeness and consistency. 
Data in the eCRF will be compared with the respective source documents to ensure that there 
are no discrepancies for critical data as described in the RBM plan. All entries, corrections, 
and alterations are to be made by the Investigator or designee. 

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If corrections are needed, queries will be raised within the eCRF, either as a result of built-in 
edit checks or manually raised by the Monitor. An appropriate member of the site staff will 
answer the queries in the eCRF either by correcting the data or by entering a response to the 
query. 
16.4 
Audit trail 
All entries in the eCRF will be fully recorded in a protected audit trail. Once clinical data 
have been saved, corrections to the data fields will be audit trailed, meaning that the reason 
for the change, the name of the person who made the change, together with time and date will 
be logged. 
16.5 
External data 
External data consists of data that are not recorded in the eCRF. Data may be received in 
electronic format or as a paper printout. Key variables are defined in order to uniquely 
identify each sample record. File and data formats are agreed upon with the external data 
provider. 
16.6 
Medical coding 
Medical coding will be performed by trained personnel at CTC. AEs and medical/surgical 
history verbatim terms are coded using the medical dictionary of regulatory activities 
(MedDRA, latest version available at eCRF setup). 
Prior and concomitant medications will be coded according to the WHO anatomic therapeutic 
chemical (ATC) classification system. 
16.7 
Database lock 
When all data have been entered and discrepancies solved, clean file will be declared, the 
database will be locked, the code will be broken, and the data will be analysed. 

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17 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE 
The principal features of the statistical analysis to be performed are described in this section. 
A more technical and detailed elaboration of the principal features will be presented in a 
separate Statistical Analysis Plan (SAP), which will be signed and approved prior to database 
lock (DBL). 
The analyses of all endpoints will be performed by CTC. 
17.1 
General 
Continuous data will in general be presented in terms of evaluable observations, arithmetic 
mean, standard deviation (SD), median, minimum, and maximum value. 
Categorical data will be presented as counts and percentages. When applicable, summary data 
will be presented by part, cohort, treatment (active/placebo) and assessment time. Individual 
participant data will be listed by part, participant number, cohort, treatment, and, where 
applicable, by assessment time. 
All descriptive summaries and statistical analyses will be performed using SAS Version 9.4 or 
later (SAS Institute, Inc., Cary, NC). The PK parameters will be calculated by non-
compartmental analysis using the software Phoenix WinNonlin® version 8.3 or later (Certara, 
U.S.A.). 
Baseline will be defined as the last non-missing data collection point prior to the 
administration of IMP. Details on potential imputation of missing data will be provided in the 
SAP. 
17.2 
Determination of sample size 
No formal sample size calculation has been performed for this trial. The proposed sample size 
is considered sufficient to provide adequate information to meet the trial objectives. 
In Part A, approximately 64 participants will be screened to achieve 32 randomised 
participants. 
In Part B, approximately 18 participants will be screened to achieve up to 9 included 
participants. 
17.3 
Analysis data sets 
There will be 2 analysis sets defined in the trial. The full analysis set (FAS) will consist of all 
enrolled participants who received at least one dose of IMP (this set will also be used for all 
safety analyses). The PK analysis set (PKAS) will consist of all randomised participants in 
Part A who received at least one dose of IMP and provided an evaluable plasma concentration 
profile, and who have no AEs or PDs judged to affect the PK analysis. Individual PK values 
may be excluded from the analysis as specified in the SAP. 
17.4 
Missing, unused and spurious data 
Methods for handling missing, unused and spurious data will be specified in the SAP. 

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17.5 
Description of trial population 
17.5.1 
Demographics and baseline characteristics 
Descriptive statistics for demographics, weight and height will be presented for all 
participants. All data will be listed by participant. 
17.5.2 
Medical/surgical history and prior/concomitant medication 
Medical/surgical history will be presented by system organ class (SOC) and preferred term 
(PT). Prior/concomitant medications will be presented by ATC levels 4 and 5. 
All data will be listed by participant. 
17.5.3 
Investigational medicinal product use 
Individual IMP use will be listed. 
17.6 
Analysis of primary endpoints 
17.6.1 
Adverse events 
An overview of all AEs, including SAEs, intensity, relationship to IMP, and deaths will be 
presented by part, cohort, treatment, and overall. The incidence of AEs and SAEs will be 
summarised by SOC and PT by treatment, cohort and overall. An overview of any treatment-
related (probably/possibly related) AEs will be summarised by SOC and PT and by treatment, 
cohort and overall if considered appropriate. All AE data will be listed by participant and 
include the verbatim term entered by the Investigator. 
17.6.2 
Local tolerability 
An overview of all local tolerability reactions including maximum intensity grade per local 
tolerability reaction will be presented by part, cohort, treatment, and overall. Intensity grade 
for each local tolerability reaction will also be presented by cohort, treatment, and overall 
using a frequency table. Changes from baseline in intensity grade at each time point will be 
summarised in a shift table. 
17.6.3 
Vital signs 
Vital signs will be summarised by treatment, cohort and overall. Data will be presented with 
absolute and percent change from baseline. All data will be listed by participant. 
17.6.4 
Electrocardiogram 
All ECGs will be categorised as ”normal”, ”abnormal, not clinically significant”, or 
”abnormal, clinically significant” (as judged by the Investigator) and summarised by part, 
cohort, treatment, overall, and assessment time point using frequency tables. Changes over 
time will be presented using a shift table if considered appropriate. All measured ECG values 
will be summarised by treatment, cohort and overall, and assessment timepoint with absolute 
and percent change from baseline. All data will be listed by participant. 

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17.6.5 
Safety laboratory 
Safety laboratory data will be summarised by part, cohort, treatment, overall, and assessment 
time point with absolute and percent change from baseline. Abnormal, clinically significant 
values will be summarised separately if considered appropriate. All data will be listed by 
participant. 
17.6.6 
Physical examinations 
Clinically significant and non-clinically significant abnormal findings will be specified and 
summarised by part, cohort, treatment, overall, and assessment time point. Changes over time 
will be presented using shift tables, if appropriate. All data will be listed by participant. 
17.6.7 
Cream abosorption (Part B) 
Cream absorption measured on a 4-point scale will be presented using a frequency table by 
cohort using descriptive statistics. The time until adequate abruption will be summarised by 
cohort. All data will be listed by participant. 
17.7 
Analysis of secondary endpoints 
17.7.1 
Analysis of pharmacokinetics (Part A) 
The PK analysis will be based on the PKAS and performed by CTC. 
The following non-compartmental PK parameters will be assessed in the trial if sufficient data 
is available: 
• AUCinf 
• AUClast 
• Cmax 
• Tmax 
• T1/2. 
For AUCinf, the area under the plasma concentration vs. time curve will be calculated to the 
timepoint of the last quantifiable plasma concentration of the trial drug and then extrapolated 
to infinity using the concentration in the last quantifiable sample and the estimated terminal 
elimination rate constant (Lambdaz). 
PK data will be presented by treatment and cohort using summary statistics with the number 
of measurements (n), arithmetic mean, SD, as well as median, minimum and maximum 
values. For all applicable PK parameters, the geometric mean and geometric coefficient of 
variation (CV%) will be presented. For the parameter Tmax, the number of observations, and 
median, minimum and maximum values will be presented only. 
All data will be listed by participant. 

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18 
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19 
SIGNATURES 
19.1 
Approval of the clinical trial protocol 
I, the undersigned, approve this CTP. 
 

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19.2 
Principal Investigator statement 
I, the undersigned, have read and understood this CTP and agree to conduct the trial 
accordingly and to comply with the Investigator obligations stated in this CTP, GCP and 
applicable regulatory requirements. 
 
Mohammad Alimohammadi, MD, PhD 
Clinical Trial Consultants AB