A Randomized, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses as Well as the Food Effect of Orally Administered ATH-399A in Healthy Adult Participants
Phase: PHASE1
Conditions: Healthy Volunteers
Sponsor: HanAll BioPharma Co., Ltd.

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PROTOCOL HL192-PD-CA-P101 
 Protocol Number: 230119 
A Randomized, Phase 1 Study to Assess the Safety, Tolerability, 
Pharmacokinetics of Single and Multiple Doses as Well as the Food 
Effect of Orally Administered ATH-399A in Healthy Adult 
Participants 
Sponsor: 
HanAll Pharmaceutical International Inc. 
1 Church St. Suite 103 
Rockville, MD 20850, USA 
HanAll Biopharma Co., Ltd. 
DaeWoong Building 3F. 
12 Bongeunsa-ro 114-gil 
Gangnam-gu, Seoul 
Republic of Korea 06170 
Investigational Product: 
ATH-399A, HL192 
Release Date: 
Contract Research 
Organization: 
26-SEP-2024 
Version Number: 
Amendment IV 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by 
applicable laws and regulations. In any event, people to whom the information is disclosed must 
be informed that the information is privileged or confidential and may not be further disclosed by 
them. These restrictions on disclosure will apply equally to all future information supplied to you 
which is indicated as privileged or confidential. 

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1 
PROTOCOL HISTORICAL FILE 
Version 
Brief description/summary of changes 
Date 
Final 
Version submitted to the Independent Ethics Committee 
(IEC). 
17-JUL-2023 
Amendment I 
Modifications made following Health Canada’s Request for 
Additional Information and other changes. 
30-AUG-2023 
Amendment II Integrations of modifications made in Protocol Clarification 
Letters. Addition of PK timepoints in SAD part and other 
associated changes. 
20-NOV-2023 
Amendment III  Addition of PK blood sample collections in MAD. 
30-NOV-2023 
Amendment IV See summary of changes list below. 
26-SEP-2024 
 
To perform future analysis of biomarkers on residual samples, changes included in Amendment 
IV are brought to: 
• Section 11.8.1 
o Part 2. Included wording to perform future research and analysis of biomarkers 
with samples collected from the Additional Cohort. The following sentences were 
added:  
▪ “In the additional cohort of participants ˃55-80 years of age (inclusive), 
future research and analysis of biomarkers may be performed using the 
residual samples originally collected for PK analysis required in this 
study. These analyses will only be performed if participants provided 
specific additional consent.” 

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SPONSOR APPROVAL 
This study will be conducted with the highest respect for the individual participants in 
accordance with the requirements of this clinical study protocol and in accordance with the 
following: 
• 
The ethical principles that have their origin in the Declaration of Helsinki. 
• 
International Council for Harmonisation E6 Good Clinical Practice. 
• 
All applicable laws and regulations, including, without limitation, data privacy laws, clinical 
trial disclosure laws, and regulations. 
The undersigned has reviewed the content of the protocol and approved for issuance. 
 
 
 
 
 
_________________________________ 
 
_______________________ ____________ 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

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INVESTIGATOR’S STATEMENT 
I have read and agree to the conduct of protocol HL192-PD-CA-P101. I am aware of my 
responsibilities as an Investigator under the guidelines of Good Clinical Practice (GCP), local 
regulations (as applicable) and the study protocol. I agree to conduct the study according to these 
guidelines and to appropriately direct and assist the staff under my control who will be involved 
in the study. 
 
________________________________________  
______________________ 
Investigator signature 
Date 
 
________________________________________ 
Investigator printed name 
 
________________________________________ 
Name of clinical facility 
 
________________________________________ 
Location of facility 
(city, state, country) 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
TABLE OF CONTENTS 
1 
PROTOCOL HISTORICAL FILE ................................................................................ 2 
SPONSOR APPROVAL ................................................................................................................ 3 
INVESTIGATOR’S STATEMENT ............................................................................................... 4 
2 
TABLE OF CONTENTS............................................................................................... 5 
3 
LIST OF ABBREVIATIONS ........................................................................................ 7 
4 
SYNOPSIS................................................................................................................... 11 
4.1 
Schedules of Assessments (SoA) ................................................................................. 21 
4.2 
Study Schema............................................................................................................... 27 
5 
INTRODUCTION ....................................................................................................... 29 
5.1 
Background .................................................................................................................. 29 
5.2 
Study Rationale ............................................................................................................ 30 
5.3 
Benefit/Risk Assessment ............................................................................................. 30 
6 
OBJECTIVES AND ENDPOINTS ............................................................................. 31 
7 
STUDY DESIGN......................................................................................................... 33 
7.1 
Overall Design ............................................................................................................. 33 
7.2 
Justification for Dose ................................................................................................... 36 
7.3 
Safety Review Committee and Dose Escalation Criteria ............................................ 37 
7.4 
End-of-Study Definition .............................................................................................. 39 
8 
STUDY POPULATION .............................................................................................. 40 
8.1 
Inclusion Criteria.......................................................................................................... 40 
8.2 
Exclusion Criteria ........................................................................................................ 41 
8.3 
Lifestyle Guideline....................................................................................................... 44 
8.4 
Screen Failures ............................................................................................................. 45 
9 
STUDY TREATMENTS AND CONCOMITANT THERAPY ................................. 46 
9.1 
Study Treatments Administered .................................................................................. 46 
9.2 
Study Drug Packaging and Labeling ........................................................................... 46 
9.3 
Study Drug Storage ...................................................................................................... 46 
9.4 
Study Drug Administration .......................................................................................... 46 
9.5 
Study Drug Accountability .......................................................................................... 47 
9.6 
Study Drug Handling and Disposal ............................................................................. 47 
9.7 
Assignment to Study Treatment................................................................................... 48 
9.8 
Blinding........................................................................................................................ 48 
9.9 
Study Treatment Compliance....................................................................................... 49 
9.10 
Treatment of Overdose................................................................................................. 49 
9.11 
Concomitant Therapy................................................................................................... 49 
10 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.................................................................... 51 
10.1 
Study Stopping Criteria................................................................................................ 51 
10.2 
Discontinuation of Study Treatment ............................................................................ 52 

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10.3 
Participant Discontinuation/Withdrawal from the Study............................................. 52 
10.4 
Lost to Follow-up......................................................................................................... 53 
11 
STUDY ASSESSMENTS AND PROCEDURES ....................................................... 54 
11.1 
Informed Consent......................................................................................................... 54 
11.2 
Height, Weight, and BMI............................................................................................. 54 
11.3 
Demographics .............................................................................................................. 55 
11.4 
Medical History............................................................................................................ 55 
11.5 
Prior and Concomitant Medications and Treatment Medications ............................... 55 
11.6 
Safety Assessments ...................................................................................................... 55 
11.7 
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Reporting57 
11.8 
Pharmacokinetics ......................................................................................................... 59 
12 
STATISTICAL CONSIDERATIONS......................................................................... 63 
12.1 
Analysis Sets ................................................................................................................ 63 
12.2 
General Considerations ................................................................................................ 63 
12.3 
Disposition and Baseline Characteristics ..................................................................... 63 
12.4 
Safety Analyses............................................................................................................ 63 
12.5 
Pharmacokinetic Analyses ........................................................................................... 64 
12.6 
Interim Analyses .......................................................................................................... 64 
12.7 
Sample Size Determination.......................................................................................... 65 
13 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................... 66 
13.1 
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...................... 66 
13.2 
Appendix 2: Clinical Laboratory Tests ........................................................................ 72 
13.3 
Appendix 3: AEs and SAEs: Definitions and Procedures for Recording, Evaluating, 
Follow-up, and Reporting ............................................................................................ 73 
13.4 
Appendix 4: Contraceptive and Barrier Guidance ....................................................... 78 
14 
REFERENCES ............................................................................................................ 81 
 
LIST OF TABLES 
Table 1: Schedule of Assessments (Part 1a) .............................................................................. 21 
Table 2:     Schedule of Assessments (Part 1b).............................................................................. 23 
Table 3: Schedule of Assessments (Part 2) ................................................................................ 25 
Table 4: PK Parameters in Animal Models................................................................................ 37 
Table 5: Study Treatments Administered .................................................................................. 46 
Table 6: Pharmacokinetic Blood Sample Collection Timepoints .............................................. 60 
Table 7: Protocol-required Safety Laboratory Tests .................................................................. 72 
 
 

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3 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
adverse event 
Ae0-t 
cumulative urinary excretion from time zero to time t 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANOVA 
analysis of variance 
aPTT 
activated partial thromboplastin time 
AQ 
amodiaquine 
AR 
accumulation ratio 
AST 
aspartate aminotransferase 
AUC 
area under the curve 
AUC0-inf 
area under the concentration-time curve from time zero to infinity (extrapolated) 
AUC0-t 
area under the concentration-time curve from time zero until the last observed 
concentration 
AUC0-τ 
area under the concentration-time curve for one dosing interval (τ) at steady-state 
BBB 
bundle branch block 
BID 
bis in die (twice a day) 
BMI 
body mass index 
BUN 
blood urea nitrogen 
Cavg 
average plasma concentration 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
creatine kinase 
Cl/F 
apparent clearance 
ClR 
renal clearance 
Cmax 
maximal observed concentration 
Cmin 
minimal observed concentration 
CQ 
Chloroquine 
CRF 
case report form 
CRO 
contract research organization 
C-SSRS 
Columbia Suicidality Severity Rating Scale 
CTA 
Clinical Trial Application 
CV 
coefficient of variation 
CYP 
cytochrome P450 

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DA 
Dopamine 
DLT 
dose limiting toxicity 
DMP 
data management plan 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition 
eGFR 
estimated glomerular filtration rate 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
eCRF 
electronic case report form 
EMA 
European Medicines Agency 
EOS 
end of study 
ET 
early termination 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
Gla 
Glafenine 
GLM 
general linear model 
GLP 
Good Laboratory Practice 
GMP 
Good Manufacturing Practice 
HAMD-7 
7-item Hamilton depression rating scale 
HbA1c 
Hemoglobin A1c 
HBsAg 
hepatitis B surface antigen 
HCG 
human chorionic gonadotrophin 
HCV 
hepatitis C virus 
HDL-C 
high-density lipoprotein cholesterol 
HED 
human equivalent doses 
HEENT 
head, eyes, ears, nose, and throat 
HIV 
human immunodeficiency virus 
HPFB 
Health Products and Food Branch 
IB 
Investigator’s Brochure 
IBBB 
incomplete bundle branch block 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IM 
Intramuscular 

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INR 
international normalized ratio 
IP 
Intraperitoneal 
IRB 
Institutional Review Board 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
IV 
Intravenous 
IVCD 
intraventricular conduction delay 
Kel 
terminal elimination rate constant 
λz (Lambda-z) 
individual estimate of the terminal elimination rate constant 
LBD 
ligand-binding domain 
LDL-C 
low-density lipoprotein cholesterol 
L-DOPA 
L-3,4-dihydroxyphenylalanine 
LH 
luteinizing hormone 
LLN 
lower limit of normal 
MAD 
multiple ascending dose 
MAOI 
monoamine oxidase inhibitor 
Max 
Maximum 
MCH 
mean cell hemoglobin 
MCHC 
mean cell hemoglobin concentration 
MCV 
mean cell volume 
mDA 
midbrain dopamine 
MDMA 
3,4-methylenedioxymethamphetamine 
MDRD 
modification of diet in renal disease 
MedDRA 
Medical Dictionary for Regulatory Activities 
Min 
Minimum 
MRSD 
maximum recommended starting dose 
NOAEL 
no observed adverse effect level 
NOL 
No Objection Letter 
OTC 
over-the-counter 
PAD 
pharmacologically active dose 
PCP 
Phencyclidine 
PD 
pharmacodynamic(s) 
PK 
pharmacokinetic(s) 
PO 
per os (oral administration) 
PR 
PR interval 
PRN 
as needed 

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PSA 
prostate-specific antigen 
PT 
prothrombin time 
QA 
quality assurance 
QC 
quality control 
QD 
quaque die (once a day) 
QT 
QT interval 
QTcF 
Fridericia’s corrected QT interval 
RBC 
red blood cell 
Rmax 
maximal rate of urinary excretion 
SAD 
single ascending dose 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SAR 
structure-activity relationship 
SAS 
statistical analysis system 
SD 
standard deviation 
SoA 
Schedule of Assessments 
SOC 
System Organ Class 
SOP 
standard operation procedure 
SRC 
Safety Review Committee 
S-STS 
Sheehan suicidality tracking scale 
SUSAR 
suspected, unexpected, serious adverse reaction 
T½ el 
terminal elimination half-life 
T3 
Triiodothyronine 
T4 
Thyroxine 
THC 
Tetrahydrocannabinol 
TID 
ter in die (three times a day) 
Tlag 
time of observation prior to the first observation with a measurable (non-zero) 
concentration 
Tmax 
time when the maximal concentration is observed 
TRmax 
time of maximal urinary excretion 
TSH 
thyroid-stimulating hormone 
ULN 
upper limit of normal 
Vz/F 
apparent volume of distribution 
WBC 
white blood cell 
WOCBP 
woman of childbearing potential 

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emerging safety/tolerability and PK data, as recommended by the SRC, but will not exceed the maximum dose 
currently outlined in the protocol. 
For each dose level, 6 participants will receive ATH-399A and 2 participants will receive placebo. Each cohort 
will utilize sentinel dosing, with one participant receiving ATH-399A and one participant receiving placebo. 
Provided no clinically significant safety issues are noted in the 48 hours after dosing the initial 2 participants in the 
cohort, the 6 remaining participants in the cohort will be dosed. Before dosing the rest of the cohort, the 
Investigator will initiate a discussion via e-mail with the Sponsor’s Medical Monitor (MM) or representative to 
review the available safety and tolerability data  of the sentinel participants in order to make a decision regarding 
continuation of the study with the remaining 6 non-sentinel participants. In the case of clinically significant safety 
issues or a sentinel stopping rule is present, then an ad hoc SRC meeting and/or a MM call can be necessary. 
Participants will be admitted to the clinical unit on the day before study drug administration (Day -1) for baseline 
assessments and to confirm eligibility. Participants will be dosed in the fasted state and will be required to fast for 
a minimum of 10 hours prior to dosing and 4 hours following dosing. Except for water given with the study drug, 
no fluids will be allowed from 1 hour before dosing until 1 hour after dosing. Participants will stay in the clinical 
unit for 4 days (3 nights), from Day -1 until Day 3. Blood samples for PK analysis for Cohorts 1, 2, and 3 will be 
collected pre‐dose and at specified time points up to Day 3 (48 hours) post‐dose and blood samples for PK analysis 
for Cohorts 4 and 5 will be collected pre-dose and at specified time points up to Day 5 (96 hours) post-dose. Urine 
samples for PK analysis will be collected from pre‐dose and during specified time intervals up to Day 3 (48 hours 
post‐dose). PK blood samples for Cohorts 4 and 5 will be collected at outpatient visits on Day 4 (72 hours post-
dose) and Day 5 (96 hours post-dose). All participants in each cohort will return for a follow-up visit on Day 8 
(between Day 8 and Day 11). 
Physical and neurological examinations, safety labs (including drug screen, cotinine test, and alcohol breath test), 
vital signs, electrocardiogram (ECG), and telemetry will be performed at specified time points. AEs will be 
recorded throughout the study. For details regarding the timing of specific procedures, see Table 1. 
Part 1b: Food Effect 
Part 1b is a 2-period, 2-sequence, crossover study part to evaluate the effect of food on ATH-399A safety, 
tolerability, and PK. 
After assessing eligibility during a 4-week screening period, approximately 12 healthy participants (with a 
minimum of 3 of each gender) will be randomized to one of the 2 sequences AB or BA and will receive the 
following study treatments in each period:  
• 
Treatment A: Single dose of ATH-399A after a high-calorie, high-fat breakfast. 
After a supervised fast of at least 10 hours, participants will be served a high-fat, high-calorie meal. Drug 
administration will occur approximately 30 minutes after the meal has been started. Except for fluids provided 
with the breakfast and water given with the study drug, no fluids will be allowed from 1 hour before until 
1 hour after dosing. 
• 
Treatment B: Single dose of ATH-399A after fasting. 
No food will be allowed from at least 10 hours before until at least 4 hours after dosing. Except for water 
given with the study drug, no fluids will be allowed from 1 hour before until 1 hour after dosing. 
Eligible participants will be admitted to the clinical unit on the day before (first) administration (Day -1) of the 
study drug, for baseline assessments and to confirm eligibility. Participants will stay in the clinical unit for 
2 periods of 3 nights each with a washout period of at least 7 days (the washout period may be adjusted based on 
PK data derived from Part 1a). Participants will be discharged from the clinical unit on Day 3 following 
completion of all assessments. Participants will then return to the clinical unit for PK blood sample collection on 
Day 4 (72 hours post-dose) and Day 5 (96 hours post-dose). After completing the washout period of at least 7 days, 
the participants will return to the clinical unit to begin their second study period, receive the study drug on Day 1 
(of the second period) and remain in the clinic through completion of their Day 3 (of the second period) 
assessments. Participants will then return to the clinical unit for PK blood sample collection on Day 4 (72 hours 
post-dose of the second period) and Day 5 (96 hours post-dose of the second period). An outpatient follow-up visit 
will take place on Day 8 in Period 2. 

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Selection of the dose to be administered in Part 1b will depend on the results of Part 1a. 
 
 
 
 
 
Blood samples for PK will be collected pre‐dose and at specified time points post‐dose. Vital signs, ECG, 
telemetry, safety lab (including drug screen, cotinine, and alcohol breath test), and physical and neurologic 
examinations will be performed at specified times. AEs will be recorded throughout the study. For details 
regarding the timing of specific procedures, see Table 2.  
Part 2 (MAD):  
Part 2 is the MAD part of the study. After assessing eligibility during the 4‐week screening period, approximately 
16 participants (with a minimum of 2 of each gender per dose level cohort) will be enrolled in 2 sequential cohorts. 
Eligible participants in each cohort will come to the clinical unit on the day before the first study drug 
administration (Day -1), for baseline assessments and to confirm eligibility and will stay in the clinical unit for 14 
days (13 nights), from Day -1 until Day 13. Participants will return to the clinical unit for outpatient PK blood 
sample collections on Day 15 (72 hours post-last dose), and Day 16 (96 hours post-last dose) as well as an 
outpatient follow-up visit that will take place 7 days after receiving the last dose of study drug, on Day 19 
(between Day 19 and Day 22). 
Each cohort will include 8 participants, 6 participants will receive ATH-399A and 2 participants will receive 
placebo. Dose levels of ATH-399A will be based on data from Part 1 (Part 1a and 1b) and recommendation from 
the SRC. Additionally, 
 
 
 
 From Day 1 to Day 12, participants will 
receive either ATH-399A or placebo once daily (QD) for a total of twelve (12) consecutive days. On Days 1 and 
12, participants will fast for a minimum of 10 hours prior to dosing and 4 hours following dosing. From Days 2 to 
11, participants will fast for a minimum of 2 hours prior to dosing and 2 hours following dosing. 
Following completion of each dose level (both cohorts), an SRC will review the safety and tolerability data, as 
well as available PK data, (assessed for up to at least 24 hours post-dose) of the previous dose level in at least 
6 evaluable participants in order to make decisions whether to escalate to the next planned dose level, decrease the 
next dose level, repeat a dose level, or to not evaluate any additional dose. The time interval when escalating the 
dose from the first dosing of Cohort 1 of the MAD to the first dosing of Cohort 2 of the MAD will be 
approximately 3.5 weeks. 
Blood samples for PK will be collected pre‐dose and at specified time points up to 96 hours post‐Day 12 dose. 
Vital signs, ECG, telemetry, safety lab (including drug screen, cotinine, and alcohol breath test), C-SSRS, and 
physical and neurologic examinations will be performed at specified times. AEs will be recorded throughout the 
study. For details regarding the timing of specific procedures see Table 3. 
Additional Cohort: Following assessment of MAD dosing in participants, an additional cohort of approximately 8 
participants will be evaluated at a dose level determined to be safe by the SRC. After assessing eligibility during 
the 4‐week screening period, 8 participants (approximately equal numbers of males and females, with a minimum 
of 2 of each gender), aged >55-80 years, inclusive, will be enrolled. The study drug will be administered once 
daily (QD) in the fasted state for a total of twelve (12) consecutive days. On Days 1 and 12, participants will fast 
for a minimum of 10 hours prior to dosing and 4 hours following dosing. From Days 2 to 11, participants will fast 
for a minimum of 2 hours prior to dosing and 2 hours following dosing. Six participants will receive ATH-399A 
and 2 participants will receive placebo once daily (QD). 
Eligible participants in this additional cohort will come to the clinical unit on the day before the first study drug 
administration (Day -1), for baseline assessments and to confirm eligibility and will stay in the clinical unit for 14 
days (13 nights), from Day -1 until Day 13. 

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Blood samples for PK will be collected pre‐dose and at specified time points up to 96 hours post‐Day 12 dose. 
Vital signs, ECG, telemetry, safety lab (including drug screen, cotinine, and alcohol breath test), C-SSRS, and 
physical and neurologic examinations will be performed at specified times. Adverse events will be recorded 
throughout the study. Participants will return to the clinical unit for outpatient PK blood sample collections on Day 
15 (72 hours post-last dose), and Day 16 (96 hours post-last dose) as well as an outpatient follow-up visit that will 
take place 7 days after receiving the last dose of study drug, on Day 19 (between Day 19 and Day 22). For details 
regarding the timing of specific procedures see Table 3. 
Safety Review Committee (SRC) and Dose Escalation Criteria: 
The study will be monitored by an SRC. The SRC is intended to ensure that treatment does not pose undue risk to 
participants. The SRC will be composed of at least the Investigator, one medically qualified Sponsor representative 
and an independent Medical Monitor (MM). SRC meetings will be held after safety and tolerability data through 
follow-up visit for at least 6 dosed participants from a same cohort and PK data up to at least 48 hours post-dose 
(Day 3 for Parts 1a and 1b) and 24 hours post-last dose (Day 13 for Part 2) from a same cohort are available. The 
SRC will consider the data on a cohort basis, but also on the basis of cumulative information across cohorts as the 
study progresses. The SRC recommendations should be based on results from a minimum of 6 evaluable 
participants in each dosing cohort. 
Safety/tolerability data through the final follow-up visit for each of the 6 evaluable participants in a cohort along 
with PK data up to at least 48 hours post-dose in Part 1a and 1b (or 24 hours post-last dose in Part 2) will be 
assessed by the SRC prior to: 
a. 
Ascending from one dose-level cohort to the next higher dose level cohort in Parts 1a and 2,   
b. Prior to transitioning from Part 1a to Parts 1b and 2. 
The SRC will stop dose escalation or descend to a dose level lower than the planned next higher dose level if any 
of the following criteria are met: 
• 
One participant per cohort who receives ATH-399A experiences a serious adverse event (SAE) which is 
considered to be related to the study medication. 
• 
Two participants per cohort who receive ATH-399A have QTc prolongation, defined as an average 
absolute (regardless of baseline value) QTcF >500 msec or an increase of QTcF > 60 msec above 
baseline, confirmed by repeating after 5 minutes, and determined post-dose. 
• 
Two participants per cohort who receive ATH-399A exhibit hypotension, defined as resting supine 
diastolic blood pressure <40 mmHg persisting for at least 10 minutes on repeated assessment, or an 
asymptomatic or symptomatic fall in systolic blood pressure to below 80 mmHg, persisting for at least 10 
minutes on repeated assessment. 
• 
Two participants per cohort who receive ATH-399A exhibit hypertension, defined as an increase in 
resting systolic blood pressure to above 180 mmHg, persisting for at least 10 minutes, or an increase in 
resting diastolic blood pressure to above 105 mmHg, persisting for at least 10 minutes. 
• 
Two participants per cohort who receive ATH-399A exhibit tachycardia, defined as resting supine heart 
rate >130 beats per minute, persisting for at least 10 minutes. 
• 
Two participants per cohort who receive ATH-399A exhibit symptomatic bradycardia, defined as heart 
rate <40 beats per minute, or asymptomatic bradycardia, defined as resting supine heart rate <30 beats per 
minute while awake, persisting for at least 10 minutes, or clinically significant arrhythmia. 
• 
One participant per cohort who receives ATH-399A exhibits abnormal liver tests defined as: 
– 
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5X upper limit of normal 
(ULN). 
– 
AST or ALT >3X ULN along with one of the following criteria: 
▪ 
sustained for more than 2 weeks or 
▪ 
total bilirubin level >2X ULN or 
▪ 
international normalized ratio (INR) time >1.5X ULN or 
▪ 
the appearance of fatigue, nausea, vomiting, right upper abdominal pain or tenderness, 
fever, rash, and/or eosinophilia (>5%). 
– 
Alkaline phosphatase (ALP) >3X ULN. 
– 
ALP >2.5X ULN and total bilirubin >2X ULN. 

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– 
ALP >2.5X ULN with the appearance of fatigue, nausea, vomiting, right upper abdominal pain 
or tenderness, fever, rash, and/or eosinophilia (>5%). 
• 
One participant per cohort who reaches a plasma AUC0-24 of ≥ 1,800 h*ng/mL. 
• 
Two participants per cohort who receive ATH-399A exhibit renal toxicity, defined as serum creatinine 
≥1.5X ULN (confirmed by repeating within 24 hours). 
• 
Two participants per cohort who receive ATH-399A exhibit hematologic toxicity, defined as one or more 
of the following (confirmed by repeating within 24 hours): 
– 
Leukocyte count <2.5 x 109/L 
– 
Neutrophils < 1.3 x 109/L and < 1.0 x 109/L for Afro-American participants 
– 
Platelet count <75 x 109/L 
In addition, the SRC may stop dose escalation or descend to a dose level lower than the planned next higher dose 
level at any time if the SRC determines that dose escalation would pose undue risk to participants. If dose 
escalation is not stopped, the SRC may recommend ascending to the planned next higher dose level cohort, 
ascending to a dose level lower than the planned next higher dose level, or may repeat dosing at the current dose 
level. 
Initially, for Parts 1a and 2, the safety and any available PK data will be reviewed by the SRC in a blinded manner 
(e.g., without participant identifiers or using reblinded participant numbers), but if the SRC considers it necessary 
due to a safety concern, individual participant data or an entire cohort’s data may be unblinded to the SRC to 
enable decision-making. Before any such unblinding, the reason for unblinding should be documented. 
Number of participants (planned):  
It is planned to enroll approximately 76 healthy adult males and females for participation in this study: 
Part 1a: approximately 40 healthy male and female participants, aged between 18-55 (inclusive) years. 
Part 1b: approximately 12 healthy male and female participants, aged between 18-55 (inclusive) years with a 
minimum of 3 participants of each gender. 
Part 2: approximately 16 healthy male and female participants, aged between 18-55 (inclusive) years with a 
minimum of 2 participants of each gender per cohort. And additional cohort of approximately 8 healthy male and 
female participants, aged between >55-80 (inclusive) years with a minimum of 2 participants of each gender. 
Criteria for Inclusion: 
1. Healthy, as determined by the Investigator based on a medical evaluation including medical history, 
physical examination, neurological examination, laboratory tests and cardiac monitoring. A participant 
with a clinical abnormality or laboratory parameters outside the reference range for the population being 
studied may be included only if, in the opinion of the Investigator, the finding is: 
a) 
not clinically significant according to the Investigator judgement 
b) unlikely to introduce additional risk to the participant,  
c) 
will not interfere with study procedures or confound study results, and  
d) is not otherwise exclusionary.  
2. Population (Section 13.4): 
a) 
Part 1a and 1b: Men and women, age 18-55 years inclusive at date of screening. 
b) Part 2: Men and women aged 18-55 years inclusive at date of screening. Additional cohort: 
Participants of the additional cohort will be of approximately equal numbers of males and 
females, with a minimum of 2 of each gender, aged >55-80 years, inclusive. 
3. Women of childbearing potential (WOCBP) including those who had bilateral tubal ligation must be non-
pregnant and non-lactating. They must use and commit to continuing to use a double barrier contraception 
method with acceptable, highly effective contraception methods from screening until study completion, 
including at least 90 days following the last study drug administration. WOCBP must have a negative 
pregnancy test result before administration of study drug and must agree not to donate ova (or egg) for at 
least 30 days after the last dose of study drug administration. Total abstinence from heterosexual 
intercourse is accepted (when this is in line with the preferred and usual lifestyle of the subject) for at 
least 6 months before screening and until at least 90 days following the last study drug administration. 

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4. Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with follicle-stimulating 
hormone [FSH] ≥40 mIU/mL). 
5. Surgically sterile women are defined as those who have had a hysterectomy and/or bilateral 
oophorectomy. Women who are surgically sterile must provide verbal confirmation. See Section 13.4. 
6. Male participants who are sexually active with WOCBP (see Section 13.4) must:  
a) 
Agree to use condoms to protect their partners from becoming pregnant during the study 
(including washout periods) and not to donate sperm for at least 90 days after the last dose of 
study drug, and  
b) Agree to ensure that they and their partners are routinely using a medically approved 
contraceptive method. It is important that male participants not impregnate others while in the 
study.  
7. Body weight ≥50.0 kg for men and ≥45.0 kg for women and body mass index within the range of 18.0-
30.0 kg/m2 (inclusive).  
8. Participants participating in Part 1b must be willing and able to consume the entire high-fat, high--calorie 
breakfast in the designated timeframe.  
9. Participants must understand the nature of the study, must be willing to participate in the study, and must 
provide signed and dated written informed consent in accordance with local regulations before the 
conduct of any study-related procedures.  
10. Participants must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, 
likely to complete all required tests, and likely to be compliant.  
11. Participants must be fluent in English or French.  
12. Participants must agree not to post any personal medical data related to the study or information related to 
the study on any website or social media site (e.g., Facebook, Twitter, etc.).  
Criteria for Exclusion: 
1. A positive urine cotinine, drug screen, or alcohol breath test at screening or Day -1. 
2. Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and 
Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria that requires current treatment with 
psychiatric medications. Participants with mild anxiety or depression which is stable for >6 months are 
permitted. 
3. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) 
within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including 
heroin, and amphetamine derivatives) within 3 months prior to screening. 
4. A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.  
5. A serious mental illness, dementia, or other neuropsychiatric disorder that would interfere with 
participation in the trial, or ability to provide informed consent in the opinion of the Investigator. 
6. Acute suicidality as indicated by the C-SSRS or history of suicidal behavior within the 12 months prior to 
screening. Participants who answer "yes" to item 4 or 5 of the Columbia -Suicide Severity Rating Scale 
(C-SSRS) at screening or Day -1, or who answer "yes" to any suicidal behavior item (excluding non-
suicidal self-injurious behavior) will not be eligible. 
7. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.  
8. A positive test at screening for human immunodeficiency virus (HIV) antigen or antibody or a history of 
positive test. 
9. Alanine aminotransferase or aspartate aminotransferase levels greater than 1.2 times the ULN at screening 
or Day -1.  
10. Frequently used any tobacco-containing (e.g., cigar, cigarette or snuff) or nicotine-containing product 
(e.g., nicotine chewing gum, nicotine plasters, or other product used for smoking cessation) within 
30 days prior to first dose administration. Frequent use is defined as >5 cigarettes per week. Use of any 
tobacco- or nicotine-containing product is prohibited within 2 weeks of first dose administration through 

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completion of the in-clinic stay for the SAD (Parts 1a and 1b) and until after the final study visit for the 
MAD (Part 2). 
11. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior 
to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of 
beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). 
12. Regularly consumed (e.g., more days than not) excessive quantities of xanthine-containing beverages 
(e.g., more than 2 cups of coffee or the equivalent per day) within 1 week prior to screening or between 
screening and first dose administration, or unwillingness to refrain from xanthine-containing beverages 
during the in-clinic stay.  
13. Received or used an investigational product (including placebo) or device within the following time 
period prior to the first dosing day in the current study: 30 days or 5 half-lives (whichever is longer). For 
biological products, administration of a biological product within 90 days prior to the first dosing, or 
concomitant participation in an investigational study involving no drug or device administration . 
14. Other than those medications outlined in the protocol body and those allowed in the MAD additional 
cohort, use of prescription or non-prescription drugs, herbal, and dietary supplements (including St John’s 
Wort) within 7 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives 
(whichever is longer) prior to first dose administration, unless in the opinion of the Investigator and 
Medical Monitor, the medication will not interfere with the study procedures or compromise participant 
safety. 
15. History of clinically significant sensitivity to any of the study drugs, or components thereof or a history of 
drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their 
participation. 
16. Donation of plasma within 7 days prior to the first dosing or donation or loss of 500 mL or more of whole 
blood within 8 weeks prior to the first dosing. 
17. A positive pregnancy test or lactation. 
18. A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, 
metabolism, or excretion. Participants with a history of cholecystectomy should be excluded. 
19. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, 
pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality. 
Participants with fully resolved childhood asthma with no hospitalizations or recurrence in adulthood are 
permitted to enroll. For the additional cohort in Part 2, any of the above are acceptable where the 
condition is stable for >6 months and, in the opinion of the Investigator, it does not impact participant 
safety. 
20. A clinically significant abnormality on physical examination, neurological examination, ECG, or 
laboratory evaluations at screening and Day -1 
21. A QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 msec during 
controlled rest at screening and Day -1, or family history of long QT syndrome. 
22. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and 
any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may 
interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or 
left ventricular hypertrophy.  
a) 
PR (PQ) interval shortening < 120 msec (PR < 120 msec but > 110 msec is acceptable if there is 
no evidence of ventricular pre-excitation).  
b) PR (PQ) interval prolongation (>220 msec), intermittent second-degree (Wenckebach block 
while asleep or in deep rest is not exclusionary) or third-degree AV block.  
c) 
Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block 
(IBBB), or intraventricular conduction delay (IVCD) with QRS > 120 msec. 
Note: at the Investigator’s discretion, if an abnormal ECG is observed, the assessment may be 
repeated. 
23. A clinically significant vital sign abnormality at screening or between screening and first dose 
administration. This includes, but is not limited to, the following in the supine position:  

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a) 
systolic blood pressure < 90 or >140 mmHg,  
b) diastolic blood pressure <50 or > 90 mmHg, or  
c) 
heart rate < 45 or >100 beats per minute.  
d) decrease in systolic blood pressure of 20 mmHg or higher, decrease in diastolic blood pressure of 
10 mmHg or higher, or increase in heart rate of 30 bpm or higher within 2 to 3 minutes after 
passing from a supine to a standing position. 
Note: at the Investigator’s discretion, if a single abnormal vital sign is observed, the assessment may be 
repeated. 
24. Significant (> 5%) weight loss or gain within 30 days prior to screening or between screening and first 
dose administration.  
25. A history of seizures. Occurrence of a single febrile seizure is not exclusionary. 
26. A history of head trauma, including closed head injury with loss of consciousness. Concussions which did 
not lead to hospitalization or loss of consciousness, and for which there are no ongoing issues, are not 
exclusionary. 
27. A history of symptomatic orthostatic hypotension (i.e., postural syncope).  
28. A history of neuroleptic malignant syndrome.  
29. A history of chronic urinary tract infections (≥2 times per year).  
30. The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the 
protocol or is unsuitable for any reason.  
31. Currently employed by NurrOn Pharmaceuticals, Inc., HanAll Pharmaceutical Inc., or HanAll Biopharma 
Co. Ltd., or by a clinical trial site participating in this study, or a first-degree relative of an NurrOn 
Pharmaceuticals, Inc. or HanAll Pharmaceutical Inc., or HanAll Biopharma Co. Ltd. employee or of an 
employee at a participating clinical trial site.  
32. Unsatisfactory venous access. 
33. Unable to swallow oral capsules. 
34. Positive result to a COVID-19 PCR test at screening or on Day-1. 
35. COVID-19 or flu vaccination within 30 days prior to study drug administration or any other vaccination 
which is judged by the investigator to potentially affect eligibility. 
36. Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or 
bacterial infection) within 2 weeks prior to first dosing. 
Investigational product, dosage, and mode of administration: ATH-399A (capsules containing 5 mg or 20 mg 
ATH-399A active doses with no excipients). Oral administration with a glass of water. 
Duration of treatment: Participants in Part 1a will receive a single dose of study drug and will be on-study for 
approximately 9 days, including Day -1. Participants in Part 1b will receive 2 doses of study drug and will be on-
study for approximately 18 days, including Day -1. Participants in Part 2 will receive QD dosing of study drug 
from Day 1 to Day 12 and will be on-study for approximately 20 days, including Day -1. 
Reference product, dosage, and mode of administration: Placebo capsules with inert filler (Avicel) will 
visually match the active capsules and will be administered orally with a glass of water. 

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Criteria for evaluation:  
Safety: 
Safety and tolerability will be assessed by changes in vital signs, ECGs, clinical laboratory tests, telemetry, 
C-SSRS, physical examination, and neurological examination, and the occurrence of AEs. 
Pharmacokinetics:  
Part 1a: Blood sampling for ATH-399A plasma concentrations will be performed pre-dose and at specified time 
points until Day 3 post-dose for Cohorts 1, 2, and 3 and until Day 5 post-dose for Cohorts 4 and 5. Urine sampling 
will be conducted on Day 1 pre-dose and 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, and 24-48 hours post-dose 
for all cohorts. 
Part 1b: Blood sampling for ATH-399A plasma concentrations will be performed pre-dose and at specified time 
points until Day 5 post-dose for each study period. 
Part 2: Blood samples to determine ATH-399A plasma concentrations will be taken pre-dose and post-dose from 
Day 1 to Day 16 at specified time points. 
Statistical methods:  
A Statistical Analysis Plan (SAP) will be finalized prior to database lock. 
Safety and tolerability 
Safety and tolerability data will be listed individually and summarized using descriptive statistics and frequency 
tables. 
Pharmacokinetic 
Individual plasma and urine concentrations, concentrations in plasma derived PK parameters will be listed 
individually, displayed in appropriate graphics, and summarized using descriptive statistics. 

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1. 
Follow-up examination will take place on Day 8 (or between Day 8 and 11). 
2. 
Discharge after completion of all study 48-hour assessments. 
3. 
Continuous eligibility assessments on Day -1 including continuous medical history on Day -1 and prior to dosing on Day 1. 
4. 
Including sex, date of birth, race, and ethnicity. 
5. 
Will be performed at Screening, at admission on Day –1, Day 1 pre-dose (up to 60 min pre-dose), and 1 (±20 min), 2 (±20 min), 4 (±20 min), 8 (±60 min), 12 (±60 min), and 
16 (±60 min) hours post-dose, at Day 2 (24 and 36 [±60 min] hours post-dose), on Day 3 (48 [±60 min] hours post-dose), and at Follow-up. Orthostatic vital signs will be 
measured at Screening and at admission on Day -1 only. 
6. 
Will be started approximately 1-2 hours pre-dose at Day 1 and will be continued to approximately 48 hours post-dose. 
7. 
Will take place at Screening (in fasted state, i.e., participants should fast for 4 hours prior to sample collection), at Day -1 (in fasted state), Day 1 at 8 hours post-dose (in not-
fasted state), at Day 2 (in fasted state), at Day 3 (in fasted state), and at Follow-up (in fasted state). HbA1c will be performed at Screening. 
8. 
Will take place at pre-dose (within 2 hours of dosing) and at 0.25 (±2 min), 0.5  (±2 min), 1 (±5 min), 1.5 (±5 min), 2 (±5 min), 3 (±10 min), 4 (±10 min), 6 (±10 min), 8 (±10 
min), 12 (±10 min), 16 (±30 min), 24 (±30 min), 36 (±30 min), and 48 (±30 min) hours post-dose for Cohorts 1-5, and at 72 (± 1 hr), and 96 (±1 hr) hours post-dose for 
Cohorts 4 and 5. 
9. 
Will be collected on Day 1 pre-dose and 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, and 24-48 hours post-dose. 
10. In potential post-menopausal women only to confirm the post-menopausal status. 
11. Women of childbearing potential (only) will have a urine pregnancy test at Screening and at discharge on Day 3, and a serum pregnancy test on Day –1. 

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4. 
Continuous eligibility assessments on Day -1 will be done only during Period 1, and continuous medical history on Day -1 and prior to dosing on Day 1 of each period. 
5. 
Including sex, date of birth, race, and ethnicity. 
6. 
Will be performed at Screening, at the admission of each period (Day –1), for each period: on Day 1 pre-dose (up to 60 minutes pre-dose), and 1 (±20 min), 2 (±20 min), 4 
(±20 min), 8 (±60 min), 12 (±60 min), and 16 (±60 min) hours post-dose; on Day 2 (24 [±60 min] hours post-dose); on Day 3 (48 [±60 min] hours post-dose), and at Follow-
up. Orthostatic vital signs will be measured at Screening and at admission on Day -1 only. 
7. 
Will be started approximately 1-2 hours pre-dose at Day 1 of each period and will be continued to approximately 48 hours post-dose. 
8. 
Will take place at Screening (in fasted state, i.e., participants should fast for 4 hours prior to sample collection), and in each period: on Day -1 (in fasted state), Day 1 at 8 
hours post-dose (in not-fasted state), at Day 2 (in fasted state), at Day 3 (in fasted state), and at Follow-up (in fasted state). HbA1c will be performed at Screening. 
9. 
Participants receiving Treatment A will be required to consume a high-calorie, high-fat meal 30 minutes prior to study drug administration. Participants receiving Treatment B 
will be administered the study drug under fasted state. 
10. Will take place at pre-dose (within 2 hours of dosing) and at 0.25 (±2 min), 0.5 (±2 min), 1 (±5 min), 1.5 (±5 min), 2 (±5 min), 3 (±10 min), 4 (±10 min), 6 (±10 min), 8 (±10 
min), 12 (±10 min), 16 (±30 min), 24 (±30 min), 36 (±30 min), 48 (±30 min), 72 (± 1 hr), and 96 (±1 hr) hours post-dose. 
11. In potential post-menopausal women only to confirm the post-menopausal status. 
12. Women of childbearing potential (only) will have a urine pregnancy test at Screening and at discharge on Day 3, and a serum pregnancy test on Day –1 of each period. 
 

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1. Follow-up examination will take place 7 days after the last dose, on Day 19 or between Day 19 and Day 22.  
2. Discharge after completion of all study 36-hour post-Day 12 dose assessments. 
3. Continuous eligibility assessments on Day -1 and Day 1 prior to dosing. 
4. Including sex, date of birth, race, and ethnicity. 
5. Will take place at Screening, at admission on Day -1, on Day 1 pre-dose (up to 60 minutes pre-dose) and 1 (±20 min), 2 (±20 min), 4 (±20 min), 6 (±60 min), 8 (±60 min), 
12 (±60 min); on Days 2-11 on pre-dose (up to 60 minutes pre-dose) and 4 (±20 min) hours post-dose; on Day 12, pre-dose (up to 60 minutes pre-dose) and 1 (±20 min), 
2 (±20 min), 4 (±20 min), and 8 (±60 min) hours post-dose; on Day 13 (in the morning); and at Follow-up. Orthostatic vital signs will be measured at Screening and at 
admission on Day -1 only. 
6. Will be started on Day 1 and Day 12: approximately 1-2 hours pre-dose and will be continued to approximately 24 hours post-dose. 
7. Will be performed at Screening (in fasted state, i.e., participants should fast for 4 hours prior to sample collection), Day -1 (in fasted state), on Day 1 at 8 hours post-dose 
(in not fasted state) and on Days 2, 6, 13 (in fasted state), and Follow-up (in fasted state). HbA1c will be performed at Screening. 
8. A thyroid panel (TSH, FT3, and FT4) will be performed at Screening, on Day -1, on Day 6, Day 13, and at the Follow-up Visit. 
9. Will take place: 
• 
on Day 1: pre-dose (within 2 hours of dosing) and 0.25 (±2 min), 0.5 (±2 min), 1 (±5 min), 1.5 (±5 min), 2 (±5 min), 3 (±10 min), 4 (±10 min), 6 (±10 min), 8 (±10 
min), 12 (±10 min), and 16 (±30 min) hours post-Day 1 dose,  
• 
on Day 2: at 24 hours (±30 min) and 36 hours (±30 min) post-Day 1 dose,  
• 
on Day 9: pre-dose (within 2 hours of dosing), 
• 
on Day 10: pre-dose (within 2 hours of dosing), 
• 
on Day 11: pre-dose (within 2 hours of dosing), 
• 
on Day 12: pre-dose (within 2 hours of dosing) and 0.25 (±2 min), 0.5 (±2 min), 1 (±5 min), 1.5 (±5 min), 2 (±5 min), 3 (±10 min), 4 (±10 min), 6 (±10 min), 8 (±10 
min), 12 (±10 min), and 16 (±30 min) hours post-Day 12 dose and  
• 
on Day 13: at 24 hours (±30 min) and 36 hours (±30 min) post-Day 12 dose.  
• 
on Day 15: at 72 (± 1 hr) hours post-Day 12 dose (outpatient visit), and 
• 
on Day 16: at 96 (±1 hr) hours post-Day 12 dose (outpatient visit). 
10. In potential post-menopausal women only to confirm the post-menopausal status. 
11. Women of childbearing potential (only) will have a urine pregnancy test at Screening and at discharge on Day 13, and a serum pregnancy test on Day -1. 
 
 

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5 
INTRODUCTION 
5.1 
Background 
Parkinson’s Disease (PD) is primarily caused by the selective degeneration of midbrain 
dopamine (mDA) neurons and is the most prevalent movement disorder, affecting 1% to 2% of 
the global population over the age of 65 (Dauer 2003; Meissner 2011; Obeso 2010). Currently 
available pharmacological treatments (e.g., L-3,4-dihydroxyphenylalanine [L-DOPA], 
Apomorphine, Totigotine) are largely symptomatic and lose their efficacy over time, with 
accompanying severe side effects such as dyskinesia. Thus, there is an unmet medical need to 
develop mechanism-based and/or disease-modifying treatments (Meissner 2011; Obeso 2010). 
NurrOn Pharmaceuticals and HanAll Pharmaceuticals, Inc. are co-developing ATH-
399A/HL192 (hereafter referred to as ATH-399A), an orally administered first-in-class small 
molecule targeting the Nurr1 nuclear receptor for the treatment of PD.  
Nurr1 is a key regulator of mDA neurons and is essential not only for development but also for 
maintenance of mDA neurons in adult brains (American Psychiatric Association. Diagnostic and 
Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). (American Psychiatric 
Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 
Castillo 1998; Saucedo-Cardenas 1998; Zetterström 1997; Kadkhodaei 2009). 
Nurr1 is the merging control point of two major signaling pathways, Shh and Wnt1, during mDA 
neuron development.  Nurr1 heterozygous null mice display behavior seen in animal models of 
PD, as they exhibit a significant decrease in both rotarod performance and locomotor activities 
associated with decreased levels of dopamine (DA) in the striatum and decreased number of A9 
DA neurons (Jiang 2005).  
Nurr1 regulates many critical dopaminergic function genes such as tyrosine hydroxylase (Kim 
2003), aromatic amino acid decarboxylase, dopamine transporter, vesicular monoamine 
transporter, and GDNF receptor c-Ret genes, which maintain the DA neurotransmitter phenotype 
and survival of the mDA neuron.  Nurr1 protects mDA neurons in part by suppressing neurotoxic 
mediators in microglia and astrocytes (Glass 2010).  
Post-mortem findings revealed that Nurr1 expression is significantly diminished in the substantia 
nigra of PD patients (Chu 2006; Moran 2007), positing Nurr1 as a potential target for developing 
novel and mechanism-based therapeutics for PD (Decressac 2013; Kim 2016; Dong 2016). In 
addition, a recent study demonstrated that Nurr1 plays critical roles in both microglia and 
astrocytes to repress proinflammatory genes and protects mDA neurons from inflammation-
induced death (Saijo 2009).   
Although Nurr1 is a promising drug target for therapeutic development for PD, the prevailing 
dogma in this research field was that it is a constitutively active, ligand-independent transcription 
factor. This dogma is based on previous studies showing that the structure of Nurr1’s ligand-
binding domain (LBD) looks like it is agonist-bound, in a transcriptionally active conformation 
and that its LBD lacks a “classical” binding pocket due to the presence of bulky hydrophobic 

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side chain residues (Wang 2003). However, NurrOn has demonstrated that Nurr1 is an “adopted” 
nuclear receptor with ligand. 
 
 
 
 
 
 
 
 
This study will be a first-in-human evaluation of the safety and pharmacokinetics of single and 
multiple doses of ATH-399A in healthy adults in the 18-55 year age range, multiple doses in 
healthy participants in the ˃55-80 year age range, and will also evaluate the effect of food on 
ATH-399A. 
5.2 
Study Rationale 
The study design meets the objectives of pharmacokinetic profile and food effect assessments 
and the evaluation of safety, tolerability and exposure profile resulting from single and multiple 
dose administration, required in Phase 1 studies. Part 2 will initially evaluate the safety of 
multiple doses in participants aged 18 – 55 years. Once safety is established, the study will 
evaluate dosing in healthy participants of either gender in the ˃55-80 year age range to match the 
approximate age range of the target PD population. A typical crossover design is adopted for the 
evaluation of food effect. The single and multiple ascending dose stages are randomized, double-
blind, and placebo-controlled. The number of participants is based on standard practices of 
clinical pharmacology and clinical development.  
5.3 
Benefit/Risk Assessment 
There have been no clinical studies of ATH-399A conducted to date; therefore, assessment of 
potential risks of ATH-399A administration are based on non-clinical data to date. 
 
  
 
 
 
 
 
 
As this first-in-human study is being conducted in healthy participants, there is no anticipated 
personal medical benefit.

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7 
STUDY DESIGN 
7.1 
Overall Design 
This study is a randomized, Phase 1 three-part study:  
• Part 1a is a placebo-controlled, double-blind, SAD, safety, tolerability, and PK evaluation 
of ATH-399A. 
• Part 1b is an open-label, single dose, food-effect, safety, tolerability, and PK evaluation 
of ATH-399A. 
• Part 2 is a placebo-controlled, double-blind, MAD, safety, tolerability, and PK evaluation 
of ATH-399A, in 2 different age groups. 
7.1.1 
Part 1a (SAD) 
After assessing eligibility during a 4‐week screening period, approximately 40 healthy 
participants will participate in Part 1a. Each eligible participant will be assigned to 1 of 5 cohorts 
(8 participants per cohort) to evaluate a total of up to 5 single ascending dose levels. Proposed 
dose levels are: 
Cohort 1: 5 mg 
Cohort 2: 10 mg 
Cohort 3: 20 mg 
Cohort 4: 40 mg 
Cohort 5: 80 mg 
The starting dose will be 5 mg. Following completion of each ascending dose level, an SRC will 
review the safety and tolerability data through the follow-up visit of a minimum of 6 evaluable 
participants. The SRC will also review PK data for up to 48 hours post-dose in at least 
6 evaluable participants in order to make decisions whether to escalate to the next planned dose 
level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. 
The determination of the highest dose level for this study will be based on emerging 
safety/tolerability and PK data, as recommended by the SRC, but will not exceed the maximum 
dose currently outlined in the protocol. 
For each dose level, 6 participants will receive ATH-399A and 2 participants will receive 
placebo. Each cohort will utilize sentinel dosing, with one participant receiving ATH-399A and 
one participant receiving placebo. Provided no clinically significant safety issues are noted in the 
48 hours after dosing the initial 2 participants in the cohort, the 6 remaining participants in the 
cohort will be dosed. Before dosing the rest of the cohort, the Investigator will initiate a 
discussion via e-mail with the Sponsor’s Medical Monitor (MM) or representative to review the 
available safety and tolerability data of the sentinel participants in order to make a decision 
regarding continuation of the study with the remaining 6 non-sentinel participants. In the case of 

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clinically significant safety issues or a sentinel stopping rule is present, then an ad hoc SRC 
meeting and/or a MM call can be necessary. 
Participants will be admitted to the clinical unit on the day before study drug administration 
(Day -1) for baseline assessments, and to confirm eligibility. Participants will be dosed in the 
fasted state and will be required to fast for a minimum of 10 hours prior to dosing and 4 hours 
following dosing. Except for water given with the study drug, no fluids will be allowed from 
1 hour before dosing until 1 hour after dosing. Participants in Study Part 1a will stay in the 
clinical unit for 4 days (3 nights), from Day -1 until Day 3. Blood samples for PK analysis for 
Cohorts 1, 2, and 3 will be collected pre‐dose and at specified time points up to Day 3 (48 hours) 
post‐dose and blood samples for PK analysis for Cohorts 4 and 5 will be collected pre-dose and 
at specified time points up to Day 5 (96 hours) post-dose. Urine samples for PK analysis will be 
collected from pre‐dose and during specified time intervals up to Day 3 (48 hours post‐dose). PK 
blood samples for Cohorts 4 and 5 will be collected at outpatient visits on Day 4 (72 hours post-
dose) and Day 5 (96 hours post-dose). All participants in each cohort will return for a follow-up 
visit on Day 8 (between Day 8 and Day 11). 
Physical and neurological examinations, safety labs (including drug screen, cotinine test, and 
alcohol breath test), vital signs, ECG, and telemetry will be performed at specified time points. 
AEs will be recorded throughout the study. For details regarding the timing of specific 
procedures, see Table 1. 
7.1.2 
Part 1b (Food Effect) 
Part 1b is a 2-period, 2-sequence, crossover study part to evaluate the effect of food on 
ATH-399A safety, tolerability, and PK. 
After assessing eligibility during a 4-week screening period, approximately 12 healthy 
participants (with a minimum of 3 of each gender) will be randomized to one of the 2 sequences 
AB or BA and will receive the following study treatments in each period:  
• 
Treatment A: Single dose of ATH-399A after a high-calorie, high-fat breakfast. 
After a supervised fast of at least 10 hours, participants will be served a high-fat, high-calorie 
meal. Drug administration will occur approximately 30 minutes after the meal has been 
started. Except for fluids provided with the breakfast and water given with the study drug, no 
fluids will be allowed from 1 hour before until 1 hour after dosing. 
• 
Treatment B: Single dose of ATH-399A after fasting. 
No food will be allowed from at least 10 hours before until at least 4 hours after dosing. 
Except for water given with the study drug, no fluids will be allowed from 1 hour before until 
1 hour after dosing. 
Eligible participants will be admitted to the clinical unit on the day before (first) administration 
(Day -1) of the study drug, for baseline assessments and to confirm eligibility. Participants will 
stay in the clinical unit for 2 periods of 3 nights each with a washout period of at least 7 days (the 
washout period may be adjusted based on PK data derived from Part 1a). Participants will be 
discharged from the clinical unit on Day 3 following completion of all assessments. Participants 
will then return to the clinical unit for PK blood sample collection on Day 4 (72 hours post-dose) 

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and Day 5 (96 hours post-dose). After completing the washout period of at least 7 days, the 
participants will return to the clinical unit to begin their second study period, receive the study 
drug on Day 1 (of the second period) and remain in the clinic through completion of their Day 3 
(of the second period) assessments. Participants will then return to the clinical unit for PK blood 
sample collection on Day 4 (72 hours post-dose of the second period) and Day 5 (96 hours post-
dose of the second period). An outpatient follow-up visit will take place on Day 8 in Period 2. 
Selection of the dose to be administered in Part 1b will depend on the results of Part 1a. 
 
 
 
 
  
Blood samples for PK will be collected pre‐dose and at specified time points post‐dose. Vital 
signs, ECG, telemetry, safety lab (including drug screen, cotinine, and alcohol breath test), and 
physical and neurologic examinations will be performed at specified times. AEs will be recorded 
throughout the study. For details regarding the timing of specific procedures, see Table 2. 
7.1.3 
Part 2 (MAD) 
Part 2 is the MAD part of the study. After assessing eligibility during the 4‐week screening 
period, approximately 16 participants (with a minimum of 2 of each gender per dose level 
cohort) will be enrolled in 2 sequential cohorts. Eligible participants in each cohort will come to 
the clinical unit on the day before the first study drug administration (Day -1), for baseline 
assessments and to confirm eligibility and will stay in the clinical unit for 14 days (13 nights), 
from Day -1 until Day 13. Participants will return to the clinical unit for outpatient PK blood 
sample collections on Day 15 (72 hours post-last dose), and Day 16 (96 hours post-last dose) as 
well as an outpatient follow-up visit that will take place 7 days after receiving the last dose of 
study drug, on Day 19 (between Day 19 and Day 22). 
Each cohort will include 8 participants, 6 participants will receive ATH-399A and 2 participants 
will receive placebo. Dose levels of ATH-399A will be based on data from Part 1 (Part 1a and 
1b) and recommendation from the SRC. Additionally, 
 
 
 
 
 
 From Day 1 to 
Day 12, participants will receive either ATH-399A or placebo once daily (QD) for a total of 
twelve (12) consecutive days. On Days 1 and 12, participants will fast for a minimum of 10 
hours prior to dosing and 4 hours following dosing. From Days 2 to 11, participants will fast for 
a minimum of 2 hours prior to dosing and 2 hours following dosing.  
Following completion of each dose level (both cohorts), an SRC will review the safety and 
tolerability data through the follow-up visit of a minimum of 6 evaluable participants. The SRC 
will also review PK data for up to 24 hours post-last dose in at least 6 evaluable participants in 

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order to make decisions whether to escalate to the next planned dose level, decrease the next 
dose level, repeat a dose level, or to not evaluate any additional dose. The time interval when 
escalating the dose from the first dosing of Cohort 1 of the MAD to the first dosing of Cohort 2 
of the MAD will be approximately 3.5 weeks. 
Blood samples for PK will be collected pre‐dose and at specified time points up to 96 hours post‐
Day 12 dose. Vital signs, ECG, telemetry, safety lab (including drug screen, cotinine, and 
alcohol breath test), C-SSRS, and physical and neurologic examinations will be performed at 
specified times. AEs will be recorded throughout the study. For details regarding the timing of 
specific procedures see Table 3. 
Additional Cohort: Following assessment of MAD dosing in participants, an additional cohort of 
approximately 8 participants will be evaluated at a dose level determined to be safe by the SRC. 
After assessing eligibility during the 4‐week screening period, 8 participants (approximately 
equal numbers of males and females, with a minimum of 2 of each gender), aged >55-80 years, 
inclusive, will be enrolled. The study drug will be administered once daily (QD) in the fasted 
state for a total of twelve (12) consecutive days. On Days 1 and 12, participants will fast for a 
minimum of 10 hours prior to dosing and 4 hours following dosing. From Days 2 to 11, 
participants will fast for a minimum of 2 hours prior to dosing and 2 hours following dosing. Six 
participants will receive ATH-399A and 2 participants will receive placebo once daily (QD).  
Eligible participants in this additional cohort will come to the clinical unit on the day before the 
first study drug administration (Day -1), for baseline assessments and to confirm eligibility and 
will stay in the clinical unit for 14 days (13 nights), from Day -1 until Day 13.  
Blood samples for PK will be collected pre‐dose and at specified time points up to 96 hours post‐
Day 12 dose. Vital signs, ECG, telemetry, safety lab (including drug screen, cotinine, and 
alcohol breath test), C-SSRS, and physical and neurologic examinations will be performed at 
specified times. Adverse events will be recorded throughout the study. Participants will return to 
the clinical unit for outpatient PK blood sample collections on Day 15 (72 hours post-last dose), 
and Day 16 (96 hours post-last dose) as well as an outpatient follow-up visit that will take place 
7 days after receiving the last dose of study drug, on Day 19 (between Day 19 and Day 22). For 
details regarding the timing of specific procedures see Table 3. 
7.2 
Justification for Dose 
 
 
 
 
 
 
 
 
 
)
 

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study progresses. The SRC recommendations should be based on results from a minimum of 
6 evaluable participants in each dosing cohort. 
Safety/tolerability data through the final follow-up visit for each of the 6 evaluable participants 
in a cohort along with PK data up to at least 48 hours post-dose in Part 1a and 1b (or 24 hours 
post-last dose in Part 2) will be assessed by the SRC prior to: 
a. Ascending from one dose-level cohort to the next higher dose level cohort in Parts 1a 
and 2,  
b. Prior to transitioning from Part 1a to Parts 1b and 2. 
The SRC will stop dose escalation or descend to a dose level lower than the planned next higher 
dose level if any of the following criteria are met: 
• One participant per cohort who receives ATH-399A experiences a serious adverse event 
(SAE) which is considered to be related to the study medication. 
• Two participants per cohort who receive ATH-399A have QTc prolongation, defined as 
an average absolute (regardless of baseline value) QTcF >500 msec or an increase of 
QTcF > 60 msec above baseline, confirmed by repeating after 5 minutes, and determined 
post-dose. 
• Two participants per cohort who receive ATH-399A exhibit hypotension, defined as 
resting supine diastolic blood pressure <40 mmHg persisting for at least 10 minutes on 
repeated assessment, or an asymptomatic or symptomatic fall in systolic blood pressure 
to below 80 mmHg, persisting for at least 10 minutes on repeated assessment. 
• Two participants per cohort who receive ATH-399A exhibit hypertension, defined as an 
increase in resting systolic blood pressure to above 180 mmHg, persisting for at least 
10 minutes, or an increase in resting diastolic blood pressure to above 105 mmHg, 
persisting for at least 10 minutes. 
• Two participants per cohort who receive ATH-399A exhibit tachycardia, defined as 
resting supine heart rate >130 beats per minute, persisting for at least 10 minutes. 
• Two participants per cohort who receive ATH-399A exhibit symptomatic bradycardia, 
defined as heart rate <40 beats per minute, or asymptomatic bradycardia, defined as 
resting supine heart rate <30 beats per minute while awake, persisting for at least 
10 minutes, or clinically significant arrhythmia. 
• One participant per cohort who receives ATH-399A exhibits abnormal liver tests defined 
as: 
– Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5X upper 
limit of normal (ULN). 
– AST or ALT >3X ULN along with one of the following criteria: 
▪ sustained for more than 2 weeks or 
▪ total bilirubin level >2X ULN or 
▪ international normalized ratio (INR) time >1.5X ULN or 
▪ the appearance of fatigue, nausea, vomiting, right upper abdominal pain or 
tenderness, fever, rash, and/or eosinophilia (>5%). 
– Alkaline phosphatase (ALP) >3X ULN. 
– ALP >2.5X ULN and total bilirubin >2X ULN. 

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– ALP >2.5X ULN with the appearance of fatigue, nausea, vomiting, right upper 
abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%). 
• One participant per cohort who reaches a plasma AUC0-24 of ≥ 1,800 h*ng/mL. 
• Two participants per cohort who receive ATH-399A exhibit renal toxicity, defined as 
serum creatinine ≥1.5X ULN (confirmed by repeating within 24 hours). 
• Two participants per cohort who receive ATH-399A exhibit hematologic toxicity, 
defined as one or more of the following (confirmed by repeating within 24 hours): 
– Leukocyte count <2.5 x 109/L 
– Neutrophils < 1.3 x 109/L and < 1.0 x 109/L for Afro-American participants 
– Platelet count <75 x 109/L 
In addition, the SRC may stop dose escalation or descend to a dose level lower than the planned 
next higher dose level at any time if the SRC determines that dose escalation would pose undue 
risk to participants. If dose escalation is not stopped, the SRC may recommend ascending to the 
planned next higher dose level cohort, ascending to a dose level lower than the planned next 
higher dose level, or may repeat dosing at the current dose level. 
 
Initially, for Parts 1a and 2, the safety and any available PK data will be reviewed by the SRC in 
a blinded manner (e.g., without participant identifiers or using reblinded participant numbers), 
but if the SRC considers it necessary due to a safety concern, individual participant data or an 
entire cohort’s data may be unblinded to the SRC to enable decision-making. Before any such 
unblinding, the reason for unblinding should be documented. 
 
Unblinding to validate treatment group where stopping criteria is met will be determined by SRC 
members. Subsequent dose escalation or descent will depend on if stopping criteria was met by 
participants who received ATH-399A as opposed to placebo. 
7.4 
End-of-Study Definition 
The study will be completed when all participants have completed their Final Study Visit 
assessments. On completion of the study, data will be reconciled, and the database will be locked 
for analysis. 

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8 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
8.1 
Inclusion Criteria 
Participants are eligible to be included in the study only if all the following criteria apply: 
1. Healthy, as determined by the Investigator based on a medical evaluation including 
medical history, physical examination, neurological examination, laboratory tests and 
cardiac monitoring. A participant with a clinical abnormality or laboratory parameters 
outside the reference range for the population being studied may be included only if, in 
the opinion of the Investigator, the finding is: 
a. not clinically significant according to the Investigator judgement 
b. unlikely to introduce additional risk to the participant,  
c. will not interfere with study procedures or confound study results, and  
d. is not otherwise exclusionary.  
2. Population (see Section 13.4): 
a. Part 1a and 1b: Men and women, age 18-55 years inclusive at date of screening. 
b. Part 2: Men and women aged 18-55 years inclusive at date of screening. 
Additional cohort: Participants of the additional cohort will be of approximately 
equal numbers of males and females, with a minimum of 2 of each gender, aged 
>55-80 years, inclusive. 
3. Women of childbearing potential (WOCBP) including those who had bilateral tubal 
ligation must be non-pregnant and non-lactating. They must use and commit to 
continuing to use a double barrier contraception method with acceptable, highly effective 
contraception methods from screening until study completion, including at least 90 days 
following the last study drug administration. WOCBP must have a negative pregnancy 
test result before administration of study drug and must agree not to donate ova (or egg) 
for at least 30 days after the last dose of study drug administration. Total abstinence from 
heterosexual intercourse is accepted (when this is in line with the preferred and usual 
lifestyle of the subject) for at least 6 months before screening and until at least 90 days 
following the last study drug administration. 
4. Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with 
follicle-stimulating hormone [FSH] ≥40 mIU/mL). 
5. Surgically sterile women are defined as those who have had a hysterectomy and/or 
bilateral oophorectomy. Women who are surgically sterile must provide verbal 
confirmation. See Section 13.4.  
6. Male participants who are sexually active with WOCBP (see Section 13.4) must:  
a. Agree to use condoms to protect their partners from becoming pregnant during the 
study (including washout periods) and not to donate sperm for at least 90 days after 
the last dose of study drug, and  

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b. Agree to ensure that they and their partners are routinely using a medically 
approved contraceptive method. It is important that male participants not 
impregnate others while in the study.  
7. Body weight ≥50.0 kg for men and ≥45.0 kg for women and body mass index within the 
range of 18.0-30.0 kg/m2 (inclusive).  
8. Participants participating in Part 1b must be willing and able to consume the entire high-
fat, high-calorie breakfast in the designated timeframe.  
9. Participants must understand the nature of the study, must be willing to participate in the 
study, and must provide signed and dated written informed consent in accordance with 
local regulations before the conduct of any study-related procedures.  
10. Participants must be, in the opinion of the Investigator, able to participate in all scheduled 
evaluations, likely to complete all required tests, and likely to be compliant.  
11. Participants must be fluent in English or French.  
12. Participants must agree not to post any personal medical data related to the study or 
information related to the study on any website or social media site (e.g., Facebook, 
Twitter, etc.). 
8.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. A positive urine cotinine, drug screen, or alcohol breath test at screening or Day -1. 
2. Any history of psychiatric disorders, including substance use disorders, according to the 
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria that 
requires current treatment with psychiatric medications (Am. Psych. Association). 
Participants with mild anxiety or depression which is stable for >6 months are permitted. 
3. History of drug abuse within 1 year prior to screening or recreational use of soft drugs 
(such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], 
crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months 
prior to screening. 
4. A diagnosis of intellectual disability (intellectual developmental disorder) or mental 
retardation.  
5. A serious mental illness, dementia, or other neuropsychiatric disorder that would interfere 
with participation in the trial, or ability to provide informed consent in the opinion of the 
Investigator. 
6. Acute suicidality as indicated by the C-SSRS or history of suicidal behavior within the 
12 months prior to screening. Participants who answer “yes” to item 4 or 5 of the 
Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or Day -1, or who answer 
“yes” to any suicidal behavior item (excluding non-suicidal self-injurious behavior) will 
not be eligible. 
7. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at 
screening.  

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8. A positive test at screening for human immunodeficiency virus (HIV) antigen or antibody 
or a history of positive test. 
9. Alanine aminotransferase or aspartate aminotransferase levels greater than 1.2 times the 
ULN at screening or Day -1.  
10. Frequently used any tobacco-containing (e.g., cigar, cigarette or snuff) or nicotine-
containing product (e.g., nicotine chewing gum, nicotine plasters, or other product used 
for smoking cessation) within 30 days prior to first dose administration. Frequent use is 
defined as >5 cigarettes per week. Use of any tobacco- or nicotine-containing product is 
prohibited within 2 weeks of first dose administration through completion of the in-clinic 
stay for the SAD (Parts 1a and 1b) and until after the final study visit for the MAD (Part 
2). 
11. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 
6 months prior to screening that exceeds 10 units for women or 15 units for men of 
alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of 
distilled alcohol 40%). 
12. Regularly consumed (e.g., more days than not) excessive quantities of xanthine-
containing beverages (e.g., more than 2 cups of coffee or the equivalent per day) within 
1 week prior to screening or between screening and first dose administration, or 
unwillingness to refrain from xanthine-containing beverages during the in-clinic stay.  
13. Received or used an investigational product (including placebo) or device within the 
following time period prior to the first dosing day in the current study: 30 days or 5 half-
lives (whichever is longer). For biological products, administration of a biological 
product within 90 days prior to the first dosing, or concomitant participation in an 
investigational study involving no drug or device administration. 
14. Other than those medications outlined in the protocol body and those allowed in the 
MAD additional cohort, use of prescription or non-prescription drugs, herbal, and dietary 
supplements (including St. John’s Wort) within 7 days (or 28 days if the drug is a 
potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to first dose 
administration, unless in the opinion of the Investigator and Medical Monitor, the 
medication will not interfere with the study procedures or compromise participant safety. 
15. History of clinically significant sensitivity to any of the study drugs, or components 
thereof or a history of drug or other allergy that, in the opinion of the Investigator or 
Medical Monitor, contraindicates their participation. 
16. Donation of plasma within 7 days prior to the first dosing or donation or loss of 500 mL 
or more of whole blood within 8 weeks prior to the first dosing. 
17. A positive pregnancy test or lactation. 
18. A history or presence of any disease, condition, or surgery likely to affect drug 
absorption, distribution, metabolism, or excretion. Participants with a history of 
cholecystectomy should be excluded. 
19. A history or presence of a clinically significant hepatic, renal, gastrointestinal, 
cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, 
dermatologic, or neurologic abnormality. Participants with fully resolved childhood 

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asthma with no hospitalizations or recurrence in adulthood are permitted to enroll. For the 
additional cohort in Part 2, any of the above are acceptable where the condition is stable 
for >6 months and, in the opinion of the Investigator, it does not impact participant 
safety. 
20. A clinically significant abnormality on physical examination, neurological examination, 
ECG, or laboratory evaluations at screening and Day -1. 
21. A QT interval measurement corrected according to the Fridericia rule (QTcF) > 450 msec 
during controlled rest at screening and Day -1, or family history of long QT syndrome. 
22. Any clinically significant abnormalities in rhythm, conduction, or morphology of the 
resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the 
Investigator or Medical Monitor, may interfere with the interpretation of QTc interval 
changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.  
a) PR (PQ) interval shortening < 120 msec (PR < 120 msec but > 110 msec is 
acceptable if there is no evidence of ventricular pre-excitation).  
b) PR (PQ) interval prolongation (>220 msec), intermittent second-degree 
(Wenckebach block while asleep or in deep rest is not exclusionary) or third-degree 
AV block.  
c) Persistent or intermittent complete bundle branch block (BBB), incomplete bundle 
branch block (IBBB), or intraventricular conduction delay (IVCD) with 
QRS > 120 msec.  
Note: at the Investigator’s discretion, if an abnormal ECG is observed, the 
assessment may be repeated. 
23. A clinically significant vital sign abnormality at screening or between screening and first 
dose administration. This includes, but is not limited to, the following in the supine 
position:  
a) systolic blood pressure < 90 or >140 mmHg,  
b) diastolic blood pressure <50 or > 90 mmHg, or  
c) heart rate < 45 or >100 beats per minute.  
d) decrease in systolic blood pressure of 20 mmHg or higher, decrease in diastolic 
blood pressure of 10 mmHg or higher, or increase in heart rate of 30 bpm or higher 
within 2 to 3 minutes after passing from a supine to a standing position. 
Note: at the Investigator’s discretion, if a single abnormal vital sign is observed, the 
assessment may be repeated. 
24. Significant (> 5%) weight loss or gain within 30 days prior to screening or between 
screening and first dose administration.  
25. A history of seizures. Occurrence of a single febrile seizure is not exclusionary. 
26. A history of head trauma, including closed head injury with loss of consciousness. 
Concussions which did not lead to hospitalization or loss of consciousness, and for which 
there are no ongoing issues, are not exclusionary. 
27. A history of symptomatic orthostatic hypotension (i.e., postural syncope).  
28. A history of neuroleptic malignant syndrome.  

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29. A history of chronic urinary tract infections (≥2 times per year).  
30. The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to 
comply with the protocol or is unsuitable for any reason.  
31. Currently employed by NurrOn Pharmaceuticals, Inc., HanAll Pharmaceutical Inc., or 
HanAll Biopharma Co. Ltd., or by a clinical trial site participating in this study, or a first-
degree relative of an NurrOn Pharmaceuticals, Inc., HanAll Pharmaceutical Inc., or HanAll 
Biopharma Co. Ltd. Employee or of an employee at a participating clinical trial site.   
32. Unsatisfactory venous access. 
33. Unable to swallow oral capsules. 
34. Positive result to a COVID-19 PCR test at screening or on Day-1. 
35. COVID-19 or flu vaccination within 30 days prior to study drug administration or any other 
vaccination which is judged by the investigator to potentially affect eligibility. 
36. Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic 
viral or bacterial infection) within 2 weeks prior to first dosing.  
8.3 
Lifestyle Guideline 
8.3.1 
Meals, Dietary, and Lifestyle Restrictions 
• Consumption of red wine, Seville oranges, grapefruit, pomegranate, pineapple or 
grapefruit juice, are prohibited from 4 days prior to admission to the clinical unit until the 
final study visit. 
• Consumption of poppy seeds (e.g., orange and poppy seed muffin, poppy seed bread) 
48 hours before screening and admission (e.g., each time a drugs of abuse test is done) is 
prohibited. 
• During in-clinic stay, participants will consume only standardized meals and snacks 
provided to them. Prune juice during mealtimes is allowed and will be provided by the 
clinic to treat constipation, if needed. 
• For participants receiving study drug in the fasted state, they will be required to fast for a 
minimum of 10 hours prior to dosing and 4 hours following dosing.  
• For participants receiving study drug in the fed state, participants will consume a 
standardized high fat, high calorie meal (in accordance with FDA Guidance for Industry, 
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology 
Considerations, June 2022). Participants are to eat the meal in 30 minutes or less and 
study drug will be administered 30 minutes (±2 minutes) after the start of the meal. The 
timing of the meal with respect to drug administration should be recorded, along with the 
amount of food consumed. Participants should then fast for 4 hours following dosing. 
• Approximately 240 to 340 mL water will be given to each participant at the time of 
administration of the study medication. At least 240 mL of water should be swallowed 
with the study drug. 

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• Except for water provided for study drug administration and fluids given with the high fat 
high calorie breakfast (food-effect cohort), no fluids will be allowed from 1 hour before 
until 1 hour after dosing. 
• The complete dose should be administered within a maximum of 5 minutes (for situations 
of multiple capsule administration).  
• No unaccustomed exercise 48 hours before every visit where blood samples are to be 
collected.  
• Participants should not receive a COVID-19 or flu vaccination within 30 days prior to 
study drug administration through the final study visit or any other vaccination which is 
judged by the investigator to potentially affect eligibility. 
8.3.2 
Caffeine, Alcohol, Drugs, and Tobacco 
• Soft or hard drugs from screening and throughout the study are prohibited; 
• During each in-clinic stay, participants will abstain from ingesting caffeine- or xanthine-
containing products (eg, coffee, tea, cola drinks, and chocolate). 
• Food or beverages containing xanthine derivatives or xanthine-related compounds 
(coffee, black/green tea, chocolate) or energy drinks from 48 hours prior to dosing until 
discharge from the clinical site. Consumption of quinine, caffeine and xanthine 
containing beverages is not allowed throughout the clinical stay and until after the final 
study visit. 
• Participants should not consume alcohol or alcohol-based products for 24 hours prior to 
admission to the clinical unit and until after the final study visit. 
• Participants who use tobacco products in excess of 5 cigarettes per week in the last 
30 days preceding screening are excluded from participation in this study. Use of any 
tobacco or nicotine-containing products is prohibited within 2 weeks of the first dose of 
study drug through the completion of the in-clinic stay for the SAD (Parts 1a and 1b) and 
until after the final study visit for the MAD (Part 2). 
8.4 
Screen Failures 
A screen failure occurs when a participant who has consented to participate in the clinical study 
is not subsequently entered in the study. A minimal set of screen failure information is required 
to ensure transparent reporting of screen failure participants to meet the CONSORT publishing 
requirements and to respond to queries from regulatory authorities. Minimal information 
includes demography, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened once.  

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9 
STUDY TREATMENTS AND CONCOMITANT THERAPY 
9.1 
Study Treatments Administered 
Study treatments to be administered in this study are provided in Table 5. 
Table 5: 
Study Treatments Administered 
Treatment Name 
ATH-399A 
Placebo 
Type  
Drug 
Drug 
Dose Formulation 
Capsule 
Capsule with inert filler (Avicel) 
Unit Dose Strength(s) 
5 and 20 mg 
N/A 
Dosage Level(s) 
5 mg to not more than 80 mg 
N/A 
Route of Administration 
Oral 
Oral 
Use 
Experimental 
Placebo 
IMP or NIMP 
IMP  
NIMP 
Sourcing 
Provided by the Sponsor  
Provided by the Sponsor 
Packaging and Labeling 
Study treatment will be provided 
in HDPE bottles with child-
resistant caps. Each bottle will be 
labeled as required per country 
requirement. 
Study treatment will be provided 
in HDPE bottles with child-
resistant caps. Each bottle will be 
labeled as required per country 
requirement. 
IMP=Investigational Medicinal Product; N/A=not applicable; NIMP=Non-Investigational Medicinal Product; 
TBD=to be determined 
9.2 
Study Drug Packaging and Labeling 
Study drug will be packaged and labeled according to current Good Manufacturing Practice and 
GCP guidelines and applicable local laws and/or regulations.  
9.3 
Study Drug Storage 
The Investigator (or designee) is responsible for the safe and proper storage of the study drug and 
placebo at the study site. 
The drug product is stable when stored at the recommended storage conditions at room 
temperature ranging around 15-25oC (59-77oF). Placebo should be stored similarly. 
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study drug received, and any discrepancies are reported to the 
Sponsor and resolved before use of the study drug. 
9.4 
Study Drug Administration 
Study drug will be administered at study site according to the Schedules of Assessments (SoA).  
The study drug will be administered to each participant with at least 240 mL of water and a 
mouth check will be performed to ensure consumption of the study drug. 

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Time of dosing will be set equal to the time when the first capsule is administered to the 
participants. 
For the fed period of Part 1b, after a supervised fast of at least 10 hours, participants will be 
served a high-fat, high-calorie meal of approximately 800 to 1000 calories (approximately ≥50% 
of total caloric content of the meal derived from fat). This meal should derive approximately 
150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. Participants 
should start the meal approximately 30 minutes prior to drug administration. Participants will be 
required to completely eat the meal in 30 minutes or less. No food will be allowed until at least 
4 hours post-dose. The total volume of water administered for dosing in the fasting period will be 
recorded and the same volume will be used for dosing in the fed period. 
For Part 2, each study drug administration will be separated by approximately 24 hours and 
should be done at approximately the same time every day. On Days 1 and 12, no food will be 
allowed from at least 10 hours before until at least 4 hours after dosing. No food will be allowed 
from at least 2 hours before until at least 2 hours after dosing for all other doses. 
Except for water given with the study drug and fluids provided with the high-fat, high-calorie 
meal, no fluids will be allowed from 1 hour before until 1 hour after each dosing. Water will be 
provided ad libitum at all other times. 
9.5 
Study Drug Accountability 
The Investigator is responsible for study drug accountability, reconciliation, and record 
maintenance. In accordance with all applicable regulatory requirements, the Investigator or 
designated study personnel must maintain study drug accountability records throughout the 
study. Further details will be provided in the Pharmacy Manual. 
The study drugs will be stored at the clinical site pharmacy as per applicable requirements in a 
locked, temperature-controlled medication room with restricted access. Container(s) will be 
labeled according to applicable regulations. 
Individual doses for each participant will be dispensed at the clinical site pharmacy, as per 
appropriate SOP and according to the randomization scheme, in appropriate 
envelopes/containers that will be identified with at least the protocol number and the participant 
randomization number. 
Study drug intended for the study cannot be used for any purpose other than that described in this 
protocol. 
9.6 
Study Drug Handling and Disposal 
Periodically and/or after completion of the study, all used, unused, damaged, and/or expired 
study drug must be reconciled and destroyed at the site if the site has an appropriate standard 
operating procedure; otherwise, remaining study drug to be shipped to location specified by 
Sponsor for destruction.  

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9.7 
Assignment to Study Treatment 
Participants will be assigned sequentially to study part and cohort, and randomized within their 
assigned part/cohort of the study. Participants will be numbered during screening and study 
procedures according to the site SOP. 
For each cohort in Parts 1a, 1b and 2, eligible participants for participation will be randomized 
(on Day 1) to receive either the active or placebo. Participants in Part 1a and Part 2 will be 
randomized in a 3:1 ratio, for a total of 6 participants per cohort receiving ATH-399A and 2 
participants receiving the placebo in each dose level. In Part 1a, two sentinel participants will be 
dosed initially (1 active and 1 placebo). The remaining 6 participants (5 actives and 1 placebo) 
will be dosed at least 48 hours later after sentinels have been evaluated.  Participants in Part 1b 
will be randomized in one of the 2 arms to receive study treatments in the sequence AB or BA. If 
PK data analyzed from Parts 1a and 1b demonstrate a potential accumulation of ATH-399A, a 
sentinel approach similarly used in Part 1a will be considered for the dosing of Part 2 where 
sentinels will be dosed on Day 1 and the remaining participants will be dosed at least 96 hours 
later, which would allow safety assessment of the sentinel subjects after steady-state has been 
attained. One randomization scheme will be produced for each cohort separately. 
Participants may be automatically replaced if they withdraw/discontinue after randomization but 
prior to any dosing. Replacement of participants who withdraw/discontinue post dose will be at 
the discretion of the Sponsor. Procedures will be performed according to the site’s SOP. 
9.8 
Blinding 
This is a randomized, double-blind (Parts 1a and 2) study using active drug (ATH-399A) and 
placebo control. Part 1b is randomized and open-label. Randomization to treatment group will be 
performed after participants have been deemed eligible for study participation. Blinding will be 
used in Parts 1a and 2 to reduce potential bias during data collection and evaluation of clinical 
endpoints. The participants and the clinical personnel involved in the collection, monitoring, 
revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the 
study will be blinded with respect to the participant’s treatment assignment (active or placebo). 
Blinding will be maintained until at least the clinical phase of the study is completed, i.e., when 
reporting and evaluation of all AEs have been completed for all cohorts. 
Designated unblinded pharmacy personnel at the clinical site not directly involved with the 
clinical aspects of the study will prepare, store, and dispense the study drug in a blinded manner, 
according to the randomization scheme. ATH-399A and placebo will have the same visual 
appearance in order to avoid compromising the study blinding. 
Participants will be randomized to treatments on Day 1. For Parts 1a and 2 (SAD and MAD, 
respectively), participants will be randomized 3:1 to active:placebo. In Part 1a, the first two 
participants in each cohort will be sentinel participants and will be randomized 1:1 to 
active:placebo. For Part 1b (food effect) participants will be randomized to 1 of 2 ATH-399A 
treatment condition sequences (AB or BA). 

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The study blind should not be broken for an individual participant except in a medical 
emergency (where knowledge of the study drug/dose level administered would affect the 
treatment of the emergency) or regulatory requirement. 
The clinical site will be provided with code break envelopes for emergency unblinding. Separate 
code breaks will be provided for replacement numbers. The decision to break the blind for a 
participant will be made on a case-by-case basis, at the discretion of the Sponsor and/or 
Investigator or designee. In the event of a medical emergency for an individual participant for 
whom knowledge of the study treatment is critical, the Investigator may break the blind 
immediately for that participant and a notification will be made to the Sponsor within 24 hours. 
If the blind is broken, the date, time and reason must be recorded on the electronic Case Report 
Form (eCRF) and any associated adverse event (AE) reported. 
Blinded PK data will be available during the course of the study. The results will be reported 
without revealing the participant’s treatment assignment. 
9.9 
Study Treatment Compliance 
Administration of study drug will be performed under the supervision of the Investigator at the 
clinical site. The investigator will be at the clinical unit on the first day of dosing for each 
participant and will remain in the clinical unit for 8 hours (based on Tmax data) post-dose for 
safety monitoring of the participants in the event an AE and/or SAE emerges.  
Compliance with study drug is defined as the participant receiving 100% of the planned dosage. 
Drug administration will be recorded and any discrepancies with the dosing regimen must be 
documented and explained in the eCRF. 
9.10 
Treatment of Overdose 
For this study, any dose of ATH-399A greater than the assigned dose for that cohort will be 
considered an overdose. 
In the event of an overdose, the Investigator should: 
• Evaluate the participant to determine, in consultation with the Medical Monitor, if 
possible, whether study treatment should be interrupted (Parts 1b and 2 only). 
• Closely monitor the participant for any AE/SAE and laboratory abnormalities as 
medically appropriate and at least until the next scheduled follow-up. 
9.11 
Concomitant Therapy 
Use of prescription or non-prescription drugs, herbal, and dietary supplements (including St. 
John’s Wort) within 7 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 
5 half-lives (whichever is longer) prior to first dose administration and throughout the duration of 
study participation is prohibited for Part 1 of the study and Part 2 for participants aged 
18-55 years, with the exception of paracetamol (acetaminophen) up to 2000 mg daily. 

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In Part 2 of the study, for the additional cohort of participants ˃55-80 years of age, the use of 
cholesterol medications, antihypertensives, hormone replacement therapy, asthma medications, 
thyroid medications, non-steroidal anti-inflammatory drugs, proton pump inhibitors, and 
antihistamines are permitted according to the medical judgement of the Investigator, as long as 
the participant is on a stable dose for at least 14 days prior to the first study drug dose. As 
needed, paracetamol up to 2000 mg per day is permitted. 
Hormonal contraceptives may be allowed if deemed to not interact with the study drug PK.  
Prune juice during mealtimes is allowed and will be provided by the clinic to treat constipation, 
if needed. 

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10 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
Discontinuation of specific sites or of the study as a whole are detailed in Section 13.1.10. 
10.1 
Study Stopping Criteria 
In the event of a life-threatening or fatal AE, the SRC will urgently convene to assess the event 
and determine if it is related to study drug. In the meantime, all dosing must be suspended until a 
decision has been made by the CRS. If the determination is made that the AE is related to study 
drug, the study will be suspended. Continuation of the study would require approval by the 
appropriate regulatory authority(ies). 
Data from any participant in the sentinel groups with significant safety issues will be reviewed 
by an ad hoc SRC, and all dosing must be suspended until a decision is made, prior to dosing the 
remaining non-sentinel participants in each cohort: 
• One participant per cohort who receives ATH-399A experiences a SAE which is 
considered to be related to the study medication. 
• Two participants per cohort who receive ATH-399A have QTc prolongation, defined as 
an average absolute (regardless of baseline value) QTcF >500 msec or an increase of 
QTcF > 60 msec above baseline, confirmed by repeating after 5 minutes, and determined 
post-dose. 
• Two participants per cohort who receive ATH-399A exhibit hypotension, defined as 
resting supine diastolic blood pressure <40 mmHg persisting for at least 10 minutes on 
repeated assessment, or an asymptomatic or symptomatic fall in systolic blood pressure 
to below 80 mmHg, persisting for at least 10 minutes on repeated assessment. 
• Two participants per cohort who receive ATH-399A exhibit hypertension, defined as an 
increase in resting systolic blood pressure to above 180 mmHg, persisting for at least 
10 minutes, or an increase in resting diastolic blood pressure to above 105 mmHg, 
persisting for at least 10 minutes. 
• Two participants per cohort who receive ATH-399A exhibit tachycardia, defined as 
resting supine heart rate >130 beats per minute, persisting for at least 10 minutes. 
• Two participants per cohort who receive ATH-399A exhibit symptomatic bradycardia, 
defined as heart rate <40 beats per minute, or asymptomatic bradycardia, defined as 
resting supine heart rate <30 beats per minute while awake, persisting for at least 
10 minutes, or clinically significant arrhythmia. 
• One participant per cohort who receives ATH-399A exhibits abnormal liver tests defined 
as: 
– Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5X upper 
limit of normal (ULN). 
– AST or ALT >3X ULN along with one of the following criteria: 
▪ total bilirubin level >2X ULN or 
▪ international normalized ratio (INR) time >1.5X ULN or 

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▪ the appearance of fatigue, nausea, vomiting, right upper abdominal pain or 
tenderness, fever, rash, and/or eosinophilia (>5%). 
– Alkaline phosphatase (ALP) >3X ULN. 
– ALP >2.5X ULN and total bilirubin >2X ULN. 
– ALP >2.5X ULN with the appearance of fatigue, nausea, vomiting, right upper 
abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%). 
• One participant per cohort who reaches a plasma AUC0-24 of ≥ 1800 ng*h/mL 
• Two participants per cohort who receive ATH-399A exhibit renal toxicity, defined as 
serum creatinine ≥1.5X ULN (confirmed by repeating within 24 hours). 
• Two participants per cohort who receive ATH-399A exhibit hematologic toxicity, 
defined as one or more of the following (confirmed by repeating within 24 hours): 
– Leukocyte count <2.5 x 109/L 
– Neutrophils < 1.3 x 109/L and < 1.0 x 109/L for Afro-American participants 
– Platelet count <75 x 109/L 
10.2 
Discontinuation of Study Treatment 
In rare instances, it may be necessary for a participant to permanently discontinue study 
treatment. If study treatment is permanently discontinued, the participant should, if at all 
possible, remain in the study to be evaluated for safety. See the SoA for data to be collected at 
the time of discontinuation of study treatment and follow-up and for any further evaluations that 
need to be completed. 
10.3 
Participant Discontinuation/Withdrawal from the Study 
• A participant may withdraw from the study at any time at the participant’s own request 
for any reason (or without providing any reason). 
• A participant may be withdrawn at any time at the discretion of the Investigator for 
safety, behavioral, significant protocol deviations, or compliance reasons.  
• A participant may be withdrawn at any time for positive pregnancy test, drug screen, 
cotinine test, or alcohol breath test. 
• At the time of discontinuing from the study, if possible, an early termination visit should 
be conducted, as shown in the SoA. The participant will be permanently discontinued 
from the study treatment and the study at that time. 
• If the participant withdraws consent for disclosure of future information, the Sponsor 
may retain and continue to use any data collected before such a withdrawal of consent. 
• A PK blood draw may be collected at the time of withdrawal. 

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10.4 
Lost to Follow-up 
A participant will be considered lost to follow-up if the participant repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible, counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether the participant wishes to and/or should continue in the 
study. 
• Before a participant is deemed lost to follow-up, the Investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls, 
followed by a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
study record. 
• Should the participant continue to be unreachable, the participant will be considered to 
have withdrawn from the study.  

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11 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and their timing are summarized in the SoAs (Table 1, Table 2, and 
Table 3).  
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The Investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
• Procedures conducted as part of the participant’s routine clinical management and 
obtained before signing of the Informed Consent Form (ICF) may be utilized for 
screening or baseline purposes provided the procedures met the protocol-specified criteria 
and were performed within the timeframe defined in the SoA. 
• In the event of a significant study-continuity issue (eg, caused by a pandemic), alternate 
strategies for participant visits, assessments, medication distribution and monitoring may 
be implemented by the Sponsor or the Investigator, as per local health authority/ethics 
requirements. 
• At time points when vitals, ECGs, and blood collections coincide, the order for 
conducting assessments should be ECGs first, then vital signs, and then blood sample 
collection.  Sample collections done outside the pre-defined time windows will not be 
considered as protocol deviations since actual post-dose sampling times will be used for 
PK and statistical analyses. Actual collection times should be recorded on the eCRF. 
• Blood and urine samples will be collected and processed as per the Analytical 
Methodology Information Sheet. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. The maximum amount of blood collected from each participant over the duration of the 
study, including that collected for eligibility and safety purposes and any extra assessments that 
may be required, will not exceed 250 mL for Part 1a and 350 mL for Parts 1b and Part 2.  
11.1 
Informed Consent 
Voluntary written informed consent must be obtained before any study procedures are 
performed, in accordance with International Council for Harmonisation (ICH) guidelines and 
requirements of informed consent (Title 21 CFR Parts 50.20 and 50.25) (Section 13.1.3). 
11.2 
Height, Weight, and BMI 
Height (cm) and weight (kg) will be collected at the time points specified in the SoAs (Table 1, 
Table 2, and Table 3). Based on these, body mass index (BMI) will be calculated. 

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11.3 
Demographics 
Participant demographics will be obtained during screening and include sex, date of birth, race, 
and ethnicity. 
11.4 
Medical History 
A complete medical and surgical history will be obtained during screening by the Investigator or 
a qualified designee. Surgical and medical history of current and clinically significant conditions 
will be recorded.  
11.5 
Prior and Concomitant Medications and Treatment Medications 
The Investigator or qualified designee will review past and current medication use. All 
medications taken by the participant within 3 months of signing the ICF through the Follow-up 
Visit, including prescription medications, over-the-counter medications, vitamins, herbal 
therapies and supplements will be recorded. Hormonal contraceptives may be allowed if deemed 
to not interact with the study drug PK. Treatment Medications are medications used for the 
treatment of SAEs. 
11.6 
Safety Assessments 
Planned timepoints for all safety assessments are provided in the SoA (Table 1, Table 2, and 
Table 3). 
11.6.1 
Physical and Neurological Examinations 
A complete physical examination will be performed at screening, at the admission and at the 
discharge and will include assessments of the following: head, eyes, ears, nose, throat (HEENT), 
neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral 
vascular, and general neurological examination. 
A brief physical examination will be performed at all other times, and will include assessments 
of the following: HEENT, chest, lungs, abdomen, dermatological, cardiovascular/peripheral 
vascular, and areas of note elicited from the participant. 
11.6.2 
Vital Signs 
The Investigator or qualified designee will assess vital signs as noted in the SoA. Vital signs 
include temperature, blood pressure, pulse rate, and respiratory rate. The participant will be 
instructed to rest in the supine position for at least 5 minutes before vital signs are assessed.  
11.6.3 
Electrocardiograms 
12-Lead ECGs will be performed in triplicate, at least 1 minute apart, all within 10 minutes, and 
will be performed and interpreted according to the site’s standard operating procedures. Average 

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values should be recorded. The ECGs will be performed after the participant has been resting in 
a supine position for at least 5 minutes. The ECG will electronically measure and calculate 
ventricular heart rate and the PR, RR, QRS, QT, and QTcF intervals. The QTcF interval will be 
used for clinical evaluations.  
If a clinically significant abnormality is detected, the abnormality should be documented as an 
AE and followed until resolution with additional ECGs as medically indicated. 
11.6.4 
12-Lead Telemetry 
12-Lead telemetry for evaluation of cardiac arrhythmias will be conducted at the time points 
noted in the SoAs.  
11.6.5 
Clinical Safety Laboratory Tests 
• See Section 13.2 for the list of clinical laboratory tests to be performed and the SoA 
(Section 4.1) for the timing and frequency. 
• The Investigator must review the laboratory results, document this review, and record any 
clinically significant changes occurring during the study as an AE. The laboratory results 
must be retained with source documents (Section 10.1).  
• All laboratory tests with values considered clinically significantly abnormal during 
participation in the study should be repeated until the values return to normal or baseline 
or are no longer considered clinically significant by the Investigator or MM. 
o If clinically significant values do not return to normal/baseline within a period of 
time judged reasonable by the Investigator, the etiology should be identified, and 
the Sponsor notified. 
o All protocol-required laboratory tests, as defined in Section 13.2, must be 
conducted in accordance with the site’s standard procedures or SOPs. 
o If laboratory values from non-protocol-specified laboratory tests performed at the 
institution’s local laboratory require a change in participant management or are 
considered clinically significant by the Investigator (eg, SAE or AE or dose 
modification), then the results must be recorded. 
11.6.6 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
The C-SSRS is a validated instrument to prospectively assess suicidal ideation and behavior 
(http://www.cssrs.columbia.edu). There are versions of the questionnaire designed for use at 
screening (Baseline/Screening version) and at baseline and visits throughout the study (Since 
Last Visit version). All versions of the C-SSRS include a series of screening questions related to 
suicidal ideation and suicidal behavior. Participant responses of “yes” to one or more screening 
questions will prompt additional questions that evaluate frequency and intensity of suicidal 
ideation and/or behavior. Participants with active suicidal behavior or suicidal ideation of type 4 
(active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal 

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ideation with specific plan and intent) based on the C-SSRS in the 12 months before screening 
based on the C-SSRS will not be eligible to participate. If the Investigator determines that a 
participant is at risk of suicide or self-harm, appropriate measures to ensure the participant’s 
safety and obtain mental health evaluation must be implemented: refer to the family physician 
and/or to the nearest hospital. A complete evaluation and medical care should be provided 
rapidly.  
The C-SSRS will be administered and scored by the Investigator or qualified clinical unit 
personnel.  
11.7 
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety 
Reporting 
The definitions of AEs and SAEs can be found in Section 13.3. 
The Investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following 
AEs to resolution and/or stabilization. This includes events reported by the participant (or, when 
appropriate, by a caregiver, surrogate, or the participant’s legally authorized representative). 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 13.3. 
11.7.1 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs will be collected continuously from time of informed consent until the Follow-up Visit 
(Section 4.1). 
Medical occurrences that begin after obtaining informed consent will be recorded as AEs. 
All SAEs will be recorded and reported to the Sponsor or designee immediately and under no 
circumstance should this exceed 24 hours, as indicated in Section 13.3. The Investigator will 
submit any updated SAE data to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek information on new AEs or SAEs after conclusion 
of the study participation. However, if the Investigator learns of any SAE, including a death, at 
any time after a participant has been discharged from the study, and the Investigator considers 
the event to be reasonably related to the study treatment or study participation, the Investigator 
must promptly notify the Sponsor. 
11.7.2 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about AE 
occurrences. 

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11.7.3 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, 
the event is otherwise explained, or the participant is lost to follow-up (as defined in 
Section 10.4). Further information on follow-up procedures is provided in Section 13.3. 
11.7.4 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of 
a study treatment under clinical investigation are met. 
• The Sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study treatment under clinical 
investigation. The Sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, Institutional Review Boards 
(IRBs)/ Ethics Committees (ECs), and Investigators. 
• An Investigator who receives an Investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will 
review and then file it along with the IB and will notify the IRB/EC, if appropriate, 
according to local requirements. 
11.7.5 
Pregnancy 
• Details of all pregnancies in female participants and, if possible, female partners of male 
participants will be collected after the start of study treatment and until the end of the 
study.  
• If a pregnancy is reported, the Investigator will record pregnancy information on the 
appropriate form and submit it to the Sponsor within 24 hours of learning of the female 
participant or female partner of male participant (after obtaining the necessary signed 
informed consent from the female partner) pregnancy. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy for medical reasons will be reported 
as an AE or SAE. 
• Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered SAEs and will be reported as 
such. 

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• The participant/pregnant female partner will be followed to determine the outcome of the 
pregnancy. The Investigator will collect follow-up information on the 
participant/pregnant female partner and the neonate and the information will be 
forwarded to the Sponsor. 
• Any female participant who becomes pregnant while participating in the study will 
discontinue study treatment or be withdrawn from the study. 
11.7.6 
Adverse Events of Special Interest 
There are currently no known adverse events of special interest for ATH-399A. 
11.8 
Pharmacokinetics 
11.8.1 
Plasma Pharmacokinetics 
Plasma concentrations of ATH-399A (and metabolite identification only in Part 1a) will be 
determined by validated method(s). 
Parts 1a and 1b PK parameters: 
• AUC0-t: Area under the concentration-time curve from time zero until the last observed 
concentration 
• AUC0-inf: Area under the concentration-time curve from time zero to infinity 
(extrapolated) 
• Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last 
observed concentration to infinity, calculated as [1 – (AUC0-t/AUC0-inf)] x 100 
• Cmax: Maximal observed concentration 
• Tmax: Time when the maximal concentration is observed 
• For Part 1b only: Tlag: Time of observation prior to the first observation with a 
measurable (non-zero) concentration. 
• t½ el: Terminal elimination half-life 
• λz: Terminal elimination rate constant 
• Cl/F: Apparent clearance 
• Vz/F: Apparent volume of distribution 
Part 2 PK parameters: 
For Day 1, the following PK parameters will be calculated: 
• AUC0-24: Area under the concentration-time curve from time zero to time 24 hours 
• Cmax: Maximal observed concentration 
• Tmax: Time when the maximal concentration is observed 
For Day 12, the following PK parameters will be calculated: 

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• AUC0-τ: Area under the concentration-time curve for one dosing interval (τ) at 
steady-state. In this study, τ = 24 hours (AUC0-24) 
• AUC0-t: Area under the concentration-time curve from time zero until the last observed 
concentration 
• AUC0-inf: Area under the concentration-time curve from time zero to infinity 
(extrapolated) 
• Cmax ss: Maximal observed concentration at steady-state 
• Tmax ss: Time when the maximal concentration is observed at steady-state 
• Cmin ss: Minimal observed concentration at steady-state 
• Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last 
observed concentration to infinity, calculated as [1 – (AUC0-t/AUC0-inf)] x 100 
• t½ el: Terminal elimination half-life 
• λz: Terminal elimination rate constant 
• Clss/F: Apparent clearance at steady-state 
• Vz ss/F: Apparent volume of distribution at steady-state 
• AR=accumulation ratio 
Blood PK sample collection will be performed at the timepoints in Table 6. 
Table 6: 
Pharmacokinetic Blood Sample Collection Timepoints 
Visit Day  
Timepoint 
Part 1a 
Part 1b 
Part 2 
Day 1 of each 
Period/Cohort 
Pre-dose (within 2 hours of dosing) 
X 
X 
X 
0.25 hours (±2 min) post-Day 1 dose 
X 
X 
X 
0.5 hours (±2 min) post-Day 1 dose 
X 
X 
X 
1 hour (±5 min) post-Day 1 dose 
X 
X 
X 
1.5 hour (±5 min) post-Day 1 dose 
X 
X 
X 
2 hours (±5 min) post-Day 1 dose 
X 
X 
X 
3 hours (±10 min) post-Day 1 dose 
X 
X 
X 
4 hours (±10 min) post-Day 1 dose 
X 
X 
X 
6 hours (±10 min) post-Day 1 dose 
X 
X 
X 
8 hours (±10 min) post-Day 1 dose 
X 
X 
X 
12 hours (±10 min) post-Day 1 dose 
X 
X 
X 
16 hours (±30 min) post-Day 1 dose 
X 
X 
X 
Day 2 of each 
Period/Cohort 
24 hours (±30 min) post-Day 1 dose 
X 
X 
X 
36 hours (±30 min) post-Day 1 dose 
X 
X 
X 
Day 3 of each 
Period/Cohort 
48 hours (±30 min) post-Day 1 dose 
X 
X 
 
Day 4 of each period 
72 hours (±1 hour) post-Day 1 dose 
(outpatient visit) 
X (Cohorts 4 
and 5 only) 
X 
 
Day 5 of each period 
96 hours (±1 hour) post-Day 1 dose 
(outpatient visit) 
X (Cohorts 4 
and 5 only) 
X 
 

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Visit Day  
Timepoint 
Part 1a 
Part 1b 
Part 2 
Day 9 of each Cohort 
Pre-dose (within 2 hours of dosing) 
 
 
X 
Day 10 of each Cohort
Pre-dose (within 2 hours of dosing) 
 
 
X 
Day 11 of each Cohort
Pre-dose (within 2 hours of dosing) 
 
 
X 
Day 12 of each Cohort 
Pre-dose (within 2 hours of dosing) 
 
 
X 
0.25 hours (±2 min) post-Day 12 dose 
 
 
X 
0.5 hours (±2 min) post-Day 12 dose 
 
 
X 
1 hour (±5 min) post-Day 12 dose 
 
 
X 
1.5 hour (±5 min) post-Day 12 dose 
 
 
X 
2 hours (±5 min) post-Day 12 dose 
 
 
X 
3 hours (±10 min) post-Day 12 dose 
 
 
X 
4 hours (±10 min) post-Day 12 dose 
 
 
X 
6 hours (±10 min) post-Day 12 dose 
 
 
X 
8 hours (±10 min) post-Day 12 dose 
 
 
X 
12 hours (±10 min) post-Day 12 dose 
 
 
X 
16 hours (±30 min) post-Day 12 dose 
 
 
X 
Day 13 of each Cohort
24 hours (±30 min) post-Day 12 dose 
 
 
X 
36 hours (±30 min) post-Day 12 dose 
 
 
X 
Day 15 of each Cohort
72 hours (±1 hour) post-Day 12 dose 
 
 
X 
Day 16 of each Cohort
96 hours (±1 hour) post-Day 12 dose 
 
 
X 
An additional aliquot may be collected at each time point and stored for future evaluation of 
ATH-399A metabolites. Any blood samples drawn beyond the specified window period will be 
noted as early or late draws and will be recorded appropriately as a protocol deviation. A 
comment and explanation should be provided in the source documents. The exact collection time 
will be recorded in the source documents. 
For Part 2: plasma concentration observed before treatment administrations (Ctrough) during 
repeated dosing (Day 9, Day 10, Day 11 and Day 12) will be presented. In the additional cohort 
of participants ˃55-80 years of age (inclusive), future research and analysis of biomarkers may 
be performed using the residual samples originally collected for PK analysis required in this 
study. These analyses will only be performed if participants provided specific additional consent. 
Refer to the Analytical Methodology Information Sheet (AMIS) for the collection, processing, 
and shipping of PK samples. 
11.8.2 
Urine Pharmacokinetics 
In Part 1a, urine samples will be collected for analysis of ATH-399A concentrations and 
identification of metabolites at pre-dose, and at the following time intervals: 0-4 hours, 4-8 
hours, 8-12 hours, 12-24 hours, and 24-48 hours post-dose. 

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If a participant cannot void their bladder within 30 minutes before dosing, a urine sample from 
an earlier morning urine collection may be used as the pre-dose sample. Voids that occur within 
the time interval will be pooled, and participants will be asked to void their bladder within 30 
minutes before the end of each collection interval, so that each new interval will begin with an 
empty bladder. Any urine voided by participants at the intersection (within 10 minutes) of two 
intervals will be included in the earlier sample. Any urine voided by participants but not 
collected will be documented. If a participant is unable to void at the end of a collection interval, 
the unsuccessful attempt will be documented. 
Refer to the AMIS for the collection, processing, and shipping of urine samples. 
For Part 1a, the following PK parameters will be calculated for [ATH-399A and metabolite(s), if 
applicable] urine concentrations: 
• Ae0-t: Cumulative urinary excretion from time zero to time t, calculated as the sum of the 
amounts excreted over each collection interval 
• Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug 
excreted in each collection interval by the time over which it was collected 
• TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection 
interval during which Rmax occurred 
• ClR: Renal clearance, calculated as Ae0-t /AUC0-t 
Additional PK parameters may be calculated. 

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12 
STATISTICAL CONSIDERATIONS 
The Statistical Analysis Plan (SAP) will be finalized prior to database lock, and it will include a 
more technical and detailed description of the statistical analyses described in this section. This 
section is a summary of the planned statistical analyses. 
12.1 
Analysis Sets 
For the purposes of analysis, the following analysis sets are defined: 
• The Safety Population includes all participants who received at least one dose of study 
medication, ATH-399A or placebo.  
• The Pharmacokinetic (PK) Population includes all participants who received at least one 
dose of ATH-399A, and provided at least one plasma or urine concentration measure. 
12.2 
General Considerations 
All collected data will be reported using summary tables and figures, as appropriate. Data 
summaries will be presented separately by part, dose, cohort, and overall.  Tabulations will be 
produced for appropriate disposition, demographic, baseline, safety, and PK parameters. 
Categorical variables will be summarized by frequency distributions (number and percentages of 
participants) and continuous variables will be summarized by descriptive statistics (mean, 
standard deviation, median, minimum, and maximum). As appropriate, a 95% confidence 
interval (CI) will be presented. Graphical displays will be presented, as appropriate. All data will 
be provided in by-participant listings. 
Baseline is defined as the last value prior to the first dose and will be flagged for all necessary 
analyses. 
12.3 
Disposition and Baseline Characteristics 
Participant disposition will be tabulated by part, cohort, treatment assignment, and dose. 
Disposition will include the number and percent of participants who are enrolled, those who 
receive treatment, discontinue early, with reasons for discontinuation, and completers. Summary 
statistics will be reported for baseline characteristics by cohort, part, treatment assignment, and 
dose.  
12.4 
Safety Analyses 
Safety and tolerability of ATH-399A will be evaluated through the assessment of AEs (i.e., 
seriousness, severity, relationship to the study drug, outcome, duration, and management), vital 
signs, 12-lead ECGs, clinical laboratory tests, and physical examinations. AEs will be coded 
using the latest version of the MedDRA dictionary. 
Demographic parameters will be summarized descriptively. 

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Safety and tolerability analysis will be performed for all participants in the safety population. No 
inferential statistical analysis of safety data is planned. 
AEs and SAEs, will be tabulated by treatment. Changes from baseline values in vital signs, 12-
lead ECGs, and clinical laboratory tests will be evaluated. Safety and tolerability data will be 
reported using descriptive statistics. 
12.5 
Pharmacokinetic Analyses 
Plasma and urine concentrations of ATH-399A will be tabulated descriptively by sampling time-
point. Plasma pharmacokinetic parameters will be calculated by non-compartmental methods. 
Descriptive statistics (n, arithmetic mean, SD, minimum, median, maximum, coefficient of 
variation [CV], geometric mean and geometric CV) of the plasma PK parameters will be 
provided by part, dose, and cohort. Individual and mean plasma concentration-time profiles will 
be presented graphically on both linear and semi-logarithmic scales for each dose level using 
nominal time points. 
For Part 1a, summary statistics will be used to describe the PK profile of [ATH-399A and 
metabolite(s), if applicable] for each dose level. The power model approach will be performed on 
AUC0-t, AUC0-inf, and Cmax data to assess the dose-proportionality. An ANOVA will also be 
performed on the untransformed Tmax, t½ el, and λz data. 
Part 1b (food effect) will be evaluated by analysis of variance, with terms for participant, 
sequence, period, treatment as fixed effects and participant within sequence as a random effect 
for the ATH-399A parameters Cmax and AUC0-t and AUC0-inf. The exposure measurements 
(AUCs and Cmax) will be log-transformed prior to analysis. The 90% CI for the ratio of 
population geometric means between test (fed) and reference products (fasting) will be provided 
for AUC0-t and AUC0-inf and Cmax. Intra- and inter-subject CV will also be estimated. 
For Part 2, summary statistics will be used to describe the PK profile of [ATH-399A and 
metabolite(s), if applicable] for each dose level. The power model approach will be performed on 
Cmax, AUC0-tau, Cmax ss, Cmin ss, AUC0-t, and AUC0-inf data to assess the dose-proportionality. An 
ANOVA will also be performed on the untransformed Tmax, Tmax ss, t½ el, and λz data. Repeated 
measures analysis will be carried out on ln transformed pre-dose concentrations (Days 9 to 12) to 
determine attainment of steady-state. Comparisons between Day 1 and Day 12 PK parameters: 
AUC0-24 versus AUC0-τ, Cmax versus Cmax ss, and Tmax versus Tmax ss will be done by ANOVA. 
Ratios (Day 12/Day1) and 90% geometric CI will be computed for AUC and Cmax. 
12.6 
Interim Analyses 
There are no planned interim analyses for this study. Safety and PK summaries will be available 
for SRC meetings. 

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12.7 
Sample Size Determination 
The sample size for each stage was determined based on standard practice in Phase 1 food effect, 
SAD and MAD studies empirically and was not powered for statistical significance. Cohort sizes 
were selected based on those commonly utilized in similar Phase 1 studies and thus generally 
considered sufficient to assess safety, tolerability, and estimate PK parameters.  
 

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13 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
13.1 
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
13.1.1 
Regulatory and Ethical Considerations 
• This study will be conducted in accordance with the protocol and with the following: 
o Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) international ethical guidelines 
o Applicable ICH GCP guidelines 
o Applicable laws and regulations 
• The protocol, protocol amendments, ICF, IB, and other relevant documents (eg, 
advertisements) must be submitted to an IRB/EC by the Investigator and reviewed and 
approved by the IRB/EC before the study is initiated. 
• Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study participants.  
• Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate 
hazard to study participants. 
• The Investigator will be responsible for the following, as applicable: 
o Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC 
o Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures 
o Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/EC, and all other applicable 
local regulations 
13.1.2 
Financial Disclosure 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information as requested to allow the Sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 

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13.1.3 
Informed Consent Process 
The Investigator agrees to provide the IEC with all appropriate documents, including a copy of 
the protocol/amendments, ICFs, advertising text (if any), IB, and any other written information 
provided to study participants. The trial will not begin until the Investigator have obtained the 
IEC favourable written approvals for the above-mentioned study documents. A properly 
executed written ICF shall be read, signed, and dated by each participant prior to entering the 
trial or prior to performing any study procedure. The original signed and dated ICF will be kept 
at the clinical site and a copy will be given to the participant. 
In the event that the protocol is amended, the revised protocol must be approved by the IEC prior 
to its implementation, unless the changes involve only logistical or administrative aspects of the 
trial. If a revised ICF is introduced during the study, each participant’s further consent must be 
obtained. The new version of the ICF must be approved by the IEC, prior to subsequently 
obtaining each participant’s consent. 
The Investigator and the Sponsor’s representative must sign the protocol and its amendments (if 
any) before initiating the study. 
It is the Sponsor’s responsibility to submit the protocol and its amendments (if any), and the 
ICFs to regulatory authorities when necessary. 
13.1.4 
Data Protection 
• Randomized participants will be assigned a unique identifier by the Sponsor. Any 
participant records or datasets that are transferred to the Sponsor will contain the 
identifier only; participant names or any information which would make the participant 
identifiable will not be transferred. 
• The participant must be informed that their personal study-related data will be used by 
the Sponsor in accordance with local data protection law. The level of disclosure must 
also be explained to the participant who will be required to give consent for their data to 
be used as described in the informed consent. 
• The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities. 
• The contract between Sponsor and study sites specifies responsibilities of the parties 
related to data protection, including handling of data security breaches and respective 
communication and cooperation of the parties. 
• Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access. 

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13.1.5 
Committees Structure 
13.1.5.1 Safety Review Committee 
An SRC will be established to review safety and any available PK data and to oversee the overall 
conduct of the study with the primary purpose of protecting the safety of participants participating 
in the study. Details concerning the specific objectives, roles, responsibilities, and data review 
procedures of the SRC are documented in a separate SRC Charter document. The SRC will be 
composed of at least the Investigator, one medically qualified Sponsor representative and an 
independent MM. 
The SRC may consult with or add members that include, but are not limited to, physician(s) 
scientists, biostatisticians, or other subject matter experts.  
The SRC will meet as soon as is feasible, upon the occurrence of safety signals and after 
completion of dosing a given cohort to recommend acceptability of continued dosing, as well as 
escalation, de-escalation, or whether to add additional participants at the current dose level.  
All data (reports) that are provided and reviewed by the SRC, including any minutes and decisions 
from the meetings, will be archived. The minutes will document clearly any questions posed and 
decisions reached and whether these decisions were unanimous. 
SRC meetings will be held after safety and tolerability data up to at least 48 hours post-dose 
(Day 3) are available for at least 6 evaluable dosed participants from a same cohort for the SAD 
part, and after safety and tolerability data up to at least 24 hours post-last dose (Day 12) are 
available for all dosed evaluable participants from a same cohort for the MAD part. PK data up 
to 24 hours post-dose (post-last dose for the MAD part) will also be reviewed to evaluate if PK 
parameters in humans are as anticipated. The SRC will consider the data on a cohort basis, but 
also on the basis of cumulative information across cohorts as the study progresses. 
The potential decisions of the SRC are: 
• Escalate to the next planned dose level; 
• Continue the study with a more conservative approach, such as decreasing to a dose-level 
lower than the planned next higher dose level, descending from a higher dose level to a 
lower dose level, repeating a dose level, or exploring an alternative dosing regimen in the 
MAD part (not exceeding the total daily dose planned in the protocol for that given 
cohort); 
• Suspend dose escalation until further review of study data can be made, allowing the SRC 
to determine whether predefined stopping rules have been met. Dose escalation may 
resume once the SRC concludes that no stopping rules have been met; 
• Stop dose escalation; 
• Terminate the study. 

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The SRC will conduct a blinded review of the data; however the blind may be broken for 
individual participants if judged necessary, prior to making a decision on dose escalation. Dose 
escalation may occur only following mutual agreement between the SRC members. The SRC 
may recommend to modify the PK sample collection schedule based on emerging data, including 
shortening or lengthening the total collection interval by up to 48 hours, and may add up to two 
additional PK samples, if necessary. Decisions taken by the SRC will be documented and 
submitted to the IEC overseeing the study, if required, along with supportive data. 
13.1.6 
Confidentiality and Retention of Study Records 
This document contains trade secrets and commercial information that is confidential and may 
not be disclosed to third parties. Persons to whom this study protocol is disclosed must be 
informed that all the information herein is confidential and may not be further divulged. These 
restrictions will apply as well to all future communications if deemed privileged or confidential. 
Publication of the study results may only be allowed with written permission from the Sponsor. 
All information on a participant obtained during the conduct of the study will be kept 
confidential. Participants will be identified by an anonymized identifier on all samples and study 
records provided to the Sponsor or designee. In compliance with ICH GCP, the Sponsor’s 
authorized representatives, monitor(s), auditor(s), IEC, and regulatory authority(ies) will be 
granted direct access to the participant’s original trial-related records for verification of clinical 
trial procedures and/or data, without violating the confidentiality of the participant, to the extent 
permitted by the applicable laws and regulations. Consent from the participant for disclosure of 
such information will be obtained in writing in the ICF. In addition, should a participant require 
medical care or hospitalization during the course of the study, the clinical site may contact the 
treating physician with the participant’s consent, except that consent may not be requested if 
there is an emergency situation. If the results of the study are published, the participant’s identity 
will remain confidential. 
The clinical sites will maintain adequate study records according to applicable regulatory 
requirements. The Sponsor will be notified prior to the destruction of study records. 
13.1.7 
Compliance 
This study will be conducted in compliance with the protocol, GCP, all applicable regulations, 
including the Federal Food, Drug and Cosmetic Act, U.S. applicable Code of Federal 
Regulations (title 21), and any IEC requirements relative to clinical studies. The study will also 
be conducted in compliance with the recommendations laid down in the most recent version of 
the Declaration of Helsinki, with the exception that registration of such Phase 1 trials in a 
publicly accessible database is not mandatory. As required by the Canadian regulatory agency, a 
Clinical Trial Application (CTA) will be submitted before the beginning of the study and a No 
Objection Letter (NOL) must be received prior to dosing. 

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13.1.8 
Data Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, security, and reliability of the 
study data presented to the Sponsor lies with the Investigator generating the data. When 
applicable, quality assurance procedures will be performed according to the site SOPs. 
The study will be monitored according to the site monitoring plan and SOP to ensure that it is 
conducted and documented properly according to the protocol, GCP, and all applicable 
regulatory requirements. The Sponsor is entitled to access information about the status of the 
study and to review the original documents of the study. 
The Sponsor may arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, SOPs, GCP, and all applicable 
regulatory requirements. In such case, audits will be independent of and separate from the 
routine monitoring and quality control functions. 
• All participant data relating to the study will be recorded on electronic CRFs unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The 
Investigator is responsible for verifying that data entries are accurate and correct by 
electronically signing the CRF. 
• Guidance on completion of CRFs will be provided in the CRF Completion Guidelines. 
• The Investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source documents. 
• Monitoring details describing strategy, including definition of study critical data items 
and processes (eg, risk-based initiatives in operations and quality such as risk 
management and mitigation strategies and analytical risk-based monitoring), methods, 
responsibilities, and requirements, including handling of noncompliance issues and 
monitoring techniques (central, remote, or on-site monitoring) are provided in the study 
monitoring plan. 
• The Sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals (eg, 
contract research organizations). 
• No records may be destroyed during the retention period without the written approval of 
the Sponsor. No records may be transferred to another location or party without written 
notification to the Sponsor. 
13.1.9 
Source Documents 
• Source documents provide evidence for the existence of the participant and substantiate 
the integrity of the data collected. Source documents are filed at the Investigator’s site. 

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• Data entered in the eCRF that are transcribed from source documents must be consistent 
with the source documents or the discrepancies must be explained.  
• The Investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
• The Sponsor or designee will perform monitoring to confirm that data entered into the 
CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the 
study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements. 
13.1.10 
Study and Site Start and Closure 
First Act of Recruitment 
The study start date is the date on which the first participant signs informed consent.  
Study/Site Termination 
The Sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
For study termination: 
• Discontinuation of further study treatment development 
For site termination: 
• Failure of the Investigator to comply with the protocol, the requirements of the IRB/EC 
or local health authorities, the Sponsor’s procedures, or GCP guidelines 
• Inadequate or no recruitment (evaluated after a reasonable amount of time) of participants 
by the Investigator 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the ECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The Investigator shall promptly inform the participant and should 
ensure appropriate participant follow-up. 
 

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13.2 
Appendix 2: Clinical Laboratory Tests 
• The tests detailed in Table 7 will be performed by the local laboratory at the time points 
specified in the SoAs.  
• Additional tests may be performed at any time during the study as determined necessary 
by the Investigator or required by local regulations. 
Table 7: 
Protocol-required Safety Laboratory Tests 
Serum or urine pregnancy: 
β-human chorionic gonadotropin (β-hCG); urine pregnancy test at screening 
and follow-up, and serum pregnancy test on Day -1 for WOCBP; in the 
absence of 12 months of amenorrhea, confirmation with at least one FSH 
measurement (≥40 IU/L or mIU/mL or per local threshold for defining 
postmenopausal state is required. 
Hematology: 
Hematocrit, hemoglobin, platelet count, RBC count, RBC distribution width, 
WBC count and differential: 
• 
Basophils 
• 
Eosinophils 
• 
Lymphocytes 
• 
Monocytes 
• 
Neutrophils 
Clinical Chemistry: 
Albumin, Alkaline phosphatase, ALT, AST, calcium, chloride, creatinine, 
creatine kinase, estimated glomerular filtration rate (eGFR, calculated using 
the MDRD equation), gamma-glutamyl transferase, glucose, phosphorus, 
potassium, sodium, total, direct and indirect bilirubin, total protein, urea 
(BUN). 
Thyroid Panel: 
TSH, FT3, FT4 
Coagulation: 
Prothrombin time (PT, unless not available due to local laboratory reporting 
standards), activated partial thromboplastin time (aPTT), and international 
normalized ratio (INR) 
Urinalysis: 
macroscopic examination, pH, specific gravity, protein, glucose, ketones, 
bilirubin, occult blood, nitrite, urobilinogen, and leukocytes. Unless 
otherwise specified, microscopic examination will be performed on abnormal 
findings. 
Serology: 
HIV antigen/antibody, HbsAg, HCV antibody, COVID-19 PCR 
Urine Drug Screen: 
Amphetamines, methamphetamines, methadone, barbiturates, 
benzodiazepines, cocaine, opiates, methyl-enedioxy methamphetamine 
(MDMA), methadone, phencyclidine, and tetrahydrocannabinol 
Breath Test: 
Alcohol  
Other: 
HbA1c (Only at screening) 
Investigators must document their review of each laboratory safety report. 
 
 

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13.3 
Appendix 3: AEs and SAEs: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting 
13.3.1 
Definition of AE 
AE Definition 
• An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study treatment, whether or not considered related to the study 
treatment. 
• NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study treatment.  
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, vital signs measurements), including those that 
worsen from baseline, considered clinically significant in the medical and scientific 
judgment of the Investigator. 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New condition detected or diagnosed after the informed consent is signed even though it 
may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
treatment or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
Events not Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 

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13.3.2 
Definition of SAE 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of 
the criteria listed: 
a. Results in death 
b. Is life-threatening 
The term life threatening in the definition of serious refers to an event in which the participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether hospitalization occurred or was necessary, the AE 
should be considered serious. 
• Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct normal 
life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) that may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 
f. 
Other situations: 
• Medical or scientific judgment should be exercised by the Investigator in deciding 
whether SAE reporting is appropriate in other situations such as important medical events 
that that may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to prevent 
one of the other outcomes listed in the above definition. These events should usually be 
considered serious. 
o Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 

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dyscrasias, convulsions not resulting in hospitalization, or development of 
treatment dependency or treatment abuse. 
13.3.3 
Recording and Follow-up of AE and/or SAE 
AE and SAE Recording 
• When an AE/SAE occurs, it is the responsibility of the Investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• The Investigator will then record all relevant AE/SAE information in the EDC tool. 
• The Investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The Investigator will make an assessment of intensity for each AE and SAE reported during the 
study per CTCAE v5.0 grading criteria:  
• Grade 1: Mild, asymptomatic or mild symptoms; clinical or diagnostic observations only; 
treatment not indicated.  
• Grade 2: Moderate, minimal, local or non-invasive treatment indicated; limiting 
age-appropriate instrumental activities of daily life.  
• Grade 3: Severe or medically significant but not immediately life-threatening: 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily life.  
• Grade 4: Life-threatening consequences; urgent treatment indicated.  
• Grade 5: Death related to AE. 
Assessment of Causality 
• The Investigator is obligated to assess the relationship between study treatment and each 
occurrence of each AE/SAE. The Investigator will use clinical judgment to determine the 
relationship. 
• All AEs will be assigned a causality attribution as follows: 
o Related: There is a reasonable likelihood of a causal relation between study drug 
and the AE. 

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o Not related: There is reasonable certainty that the cause of the AE is another 
etiology such as concomitant medication, disease progressions or other medical 
conditions and not related to study treatment. 
• For causality assessment, the Investigator will also consult the IB and/or product 
information for marketed products. 
• The Investigator must review and provide an assessment of causality for each AE/SAE 
and document this in the medical notes. There may be situations in which an SAE has 
occurred and the Investigator has minimal information to include in the initial report. 
However, it is very important that the Investigator always assesses causality for every 
event before the initial transmission of the SAE data. 
• The Investigator may change their opinion of causality based on follow-up information 
and send an SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AEs and SAEs 
• The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the Sponsor 
or designee to elucidate the nature and/or causality of the AE or SAE as fully as possible. 
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
• New or updated information will be recorded in the originally submitted documents. 
• The Investigator will submit any updated SAE data to the Sponsor (or designee) 
within 24 hours of investigator learning about the event. 
13.3.4 
Reporting of SAEs 
Serious Adverse Event Reporting to the Sponsor 
The site will enter the SAE data into the electronic system as soon as it becomes aware of the 
event. Any SAE will be reported to the Sponsor (or representative) within 24 hours of learning of 
the event, and then a written report will be completed and provided as soon as possible, but no 
later than 7 calendar days of first knowledge of the event. The notification must be directed to: 
 
  
  
Information on SAEs will be recorded on the SAE Report Form. Blank copies are included in the 
study Investigator’s file. It is not acceptable for the Investigator to send photocopies of the 
patient’s medical records to the Sponsor company or its representative in lieu of completion of 

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the appropriate AE eCRF page or SAE Report Form. However, there may be instances when 
copies of medical records for certain cases are requested by the Sponsor or its representative. In 
this instance, all subject identifiers will be blinded on the copies of the medical records before 
submission to the Sponsor or its representative. 
The completed SAE Form and SAE cover sheet should be sent via fax or e-mail immediately 
upon completion to 
. If the Investigator does not 
have all information regarding an SAE, he/she will not wait to receive additional information 
before completing and sending the form. 
Additional relevant information or clinical follow-up should be sent via fax or e-mail to 
 
 as soon as it becomes available. The Investigator should 
follow the subject with the event until resolution or stabilization of the condition. Follow-up 
reports (as many as required) should be completed and faxed/e-mailed following the same 
procedure above. 
A final report is required once the condition is resolved or stabilized and no more information 
about the event is expected. The final report should be completed and faxed/e-mailed following 
the same procedure above. 
The Investigator must keep a copy of all documentation related to the event in the clinical site 
files. 
If the Investigator learns of any SAE, including death, at any other time after a subject completes 
the study, and he/she considers the event reasonably related to the study drug, the Investigator 
will promptly notify the Sponsor/Medical Monitor. 
Serious Adverse Event Reporting to the IEC and Regulatory Agency(ies) 
It is the responsibility of the clinical site to report suspected, unexpected, serious adverse 
reactions (SUSARs) to the IEC responsible for the study per their policies. Report of fatal or life 
threatening SUSARs must be made as soon as possible, but no later than 7 calendar days after 
first knowledge of the event. Report of SUSARs that are neither fatal nor life threatening must be 
made as soon as possible, but no later than 15 calendar days after first knowledge of the event. 
The Sponsor (or representative) is responsible for notifying the regulatory agency(ies) of 
SUSARs observed during the study conduct per their regulations, as soon as possible but no later 
than 7 calendar days after becoming aware of the information when fatal or life-threatening, or 
15 calendar days when neither fatal nor life-threatening. The Sponsor (or representative) is 
responsible to comply with any other applicable regulatory requirement(s) related to the 
reporting of SAE to other regulatory authority(ies). 
 
 

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13.4 
Appendix 4: Contraceptive and Barrier Guidance 
Males 
1. Male participants, who agree to remain abstinent (when this is in line with the preferred 
and usual lifestyle of the participants) for the duration of the study (from first study 
treatment administration until 90 days following the last dose): 
CONTRACEPTION REQUIRED: Abstinence (sexual abstinence is considered a 
highly effective method only if defined as refraining from heterosexual intercourse 
during the entire period of risk associated with the study treatments. The reliability of 
sexual abstinence needs to be evaluated in relation to the duration of the clinical study 
and the preferred and usual lifestyle of the participant).  
If the situation changes post-dose during the study, participants must use an 
acceptable method of contraception (see Section 13.4).   
2. Male participants, who anticipate being sexually active during the study period (from first 
study treatment administration until 90 days following the last dose) with a woman who 
is either a woman of childbearing potential (WOCBP), a woman who is pregnant and/or 
breast feeding:  
CONTRACEPTION REQUIRED (see Section 13.4): From the first day of dosing 
until 90 days following the last dose. Documentation can be obtained from the site 
personnel’s review of the participant’s medical records or verbal confirmation at 
medical history interview. Acceptable methods are: 
▪ Surgical sterilisation (vasectomy with documentation of azoospermia) and 
a barrier method (condom). 
▪ The participant’s female partner uses oral contraceptives (combined 
hormonal contraception), injectable progesterone, or subdermal implants 
and a barrier method (condom). 
▪ The participant’s female partner uses medically prescribed topically-
applied transdermal contraceptive patch and a barrier method (condom). 
▪ The participant’s female partner has undergone documented tubal ligation 
(female sterilisation). In addition, a barrier method (condom) must be 
used. 
▪ The participant’s female partner has undergone documented placement of 
an intrauterine device (IUD) or intrauterine hormone-releasing system 
(IUS) and the use of a barrier method (condom). 
Male participants must use a condom when engaged in intercourse and should not donate 
sperm during the study and for 90 days after the last dose of study drug. 

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Females 
3. Female participants of non-childbearing potential: Defined as either postmenopausal 
(must have had ≥12 months of spontaneous amenorrhea with FSH ≥40 mIU/mL), or 
surgical sterilization (evidence of hysterectomy and/or bilateral oophorectomy). 
CONTRACEPTION REQUIRED: None. 
4. Female participants of childbearing potential (WOCBP) who anticipate being sexually 
active with a male during the study (from one complete menstrual cycle and at least 
30 days prior to the first study drug administration until at least 90 days following the 
final study drug administration): 
CONTRACEPTION REQUIRED: Highly effective double-barrier contraception must be 
used from screening (with at least 1 method that must have been started one complete 
menstrual cycle and at least 30 days prior to the first day of dosing) and continue until at 
least 90 days following the final study drug administration. A condom is required along 
with another form of highly effective contraception from the day of screening until at 
least 90 days following the final drug administration. Documentation can be obtained 
from the site personnel’s review of the participant’s medical records or verbal 
confirmation at medical history interview. Highly effective contraception methods for 
WOCBP include: 
• Progestogen-only hormonal contraception associated with inhibition of ovulation 
− oral 
− injectable 
− implantable 
• Combined hormonal contraception (ie, estrogen- and progestogen-containing) 
• IUS 
• IUD 
• Bilateral tubal occlusion 
• Infertile male partner (eg, vasectomized, permanently sterile following bilateral 
orchidectomy, or any other documented cause of infertility) 
5. Female participants of childbearing potential (WOCBP) who agree to remain abstinent 
(when this is in line with the preferred and usual lifestyle of the participant) is acceptable 
from 6 months prior to the first IMP administration until at least 90 days following the 
final study drug administration): 
CONTRACEPTION REQUIRED: Abstinence (sexual abstinence is considered a highly 
effective method only if defined as refraining from heterosexual intercourse, when this is 
in line with the preferred and usual lifestyle of the subject, for at least 6 months before 
screening and until at least 90 days following the last study drug administration). The 

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reliability of sexual abstinence needs to be evaluated in relation to the duration of the 
clinical study and the preferred and usual lifestyle of the participant. Calendar, 
symptothermal and postovulation methods of contraception are not considered to be 
equivalent to abstinence). 
No contraceptive methods are required for participants with same-sex partners. 

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14 
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