Clinical trial NCT04592549
Conditions: SARS-CoV-2
Sponsor: Resilience Government Services, Inc.
Start date: 2020-12-04; Completion date: 2023-10-06
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.

Detailed description:
The primary objective of this study is to assess the safety and tolerability of escalating IM doses of ADM03820 in healthy adults. Secondary objectives include assessing the pharmacokinetic characteristics and immunogenicity.

Arms: arm 1: Subjects in cohort 1 will receive a 150 mg dose IM injection of either active drug or placebo.

Cohort 1 will dose 8 subjects to active drug and 2 subject to placebo arm 2: Subjects in cohort 2 will receive 300 mg IM injection of either active drug or placebo.

Cohort 2 will dose 8 subjects to active drug and 2 subject to placebo. arm 3: Subjects in cohort 3 will receive 300 mg IM injection of either active drug or placebo.

Cohort 3 will dose 8 subjects to active drug and 2 subject to placebo arm 4: Subjects in cohort 4 will receive 300 mg IM injection of either active drug or placebo.

Cohort 4 will dose 8 subjects to active drug and 2 subject to placebo arm 5: Subjects in cohort 5 will receive 600 mg IM injection of either active drug or placebo.

Cohort 5 will dose 8 subjects to active drug and 2 subject to placebo
Interventions: intervention 1: ADM03820 intervention 2: Placebo
Intervention descriptions: intervention 1: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies intervention 2: Placebo

Protocol documents:
Prot_000.pdf: 
Resilience Government Services 
 
Proprietary 
 
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation 
Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of 
ADM03820 in Adults  
 
Resilience Government Services Protocol Number:  ADM03820-001 
 
IND Sponsor: Resilience Government Services, Inc. 
 
 
 
 
Version: 7.0 
 August 8, 2023 
 


Protocol: ADM03820-001 
Version 7.0 
 
August 8, 2023 
Resilience Government Services 
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STATEMENT OF COMPLIANCE 
The study will be carried out in accordance with Good Clinical Practices (GCP) as required by 
the following: 
• United States Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46; 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, and 21 CFR Part 
312); 
• International Conference on Harmonization (ICH) E6; 62 Federal Register 25691 
(1997); 
• Department of Defense (DOD) Clinical Terms of Award, as applicable. 
• Applicable Laws and Regulations 
Compliance with these standards provides public assurance that the rights, safety and well-being 
of study subjects are protected, consistent with the principles that have their origin in the 
Declaration of Helsinki. 
All key personnel (all individuals responsible for the design and conduct of this study) have 
completed Human Subjects Protection Training. 


Protocol: ADM03820-001 
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Signature Page 
The signature below constitutes the approval of this protocol and the attachments and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable United States of America (US) federal regulations and 
ICH guidelines. 
 
Site Investigator: ____________________________________       
 
 
Signature:     _______________________________________  
  
 
Date:               _____________________ 
 
 
   
 
Sponsor:          Wael El-Amin, MD / Medical Lead 
 
 
Signature:     _________________________________    
  
 
Date:               _____________________ 
 
8/21/2023


Protocol: ADM03820-001 
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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE .................................................................................................2 
TABLE OF CONTENTS .................................................................................................................4 
LIST OF ABBREVIATIONS ..........................................................................................................9 
SUMMARY OF CHANGES FOR VERSION 7.0 ........................................................................13 
SUMMARY OF CHANGES FOR VERSION 6.0 ........................................................................16 
SUMMARY OF CHANGES FOR VERSION 5.0 ........................................................................35 
SUMMARY OF CHANGES FOR VERSION 4.0 ........................................................................40 
SUMMARY OF CHANGES FOR VERSION 3.0 ........................................................................46 
SUMMARY OF CHANGES FOR VERSION 2.0 ........................................................................62 
PROTOCOL SUMMARY .............................................................................................................74 
1. 
KEY ROLES ..............................................................................................................81 
2. 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ...................83 
2.1. 
Background Information .............................................................................................83 
2.1.1. 
Introduction .................................................................................................................83 
2.1.2. 
Currently Available Treatments .................................................................................84 
2.1.3. 
ADM03820 Development ..........................................................................................85 
2.1.4. 
Public Readiness and Emergency Preparedness Act ..................................................85 
2.2. 
Rationale for Use of ADM03820 ...............................................................................86 
2.3. 
Potential Risks and Benefits .......................................................................................87 
2.3.1. 
Potential Risks ............................................................................................................87 
2.3.2. 
Known Potential Benefits ...........................................................................................88 
3. 
OBJECTIVES .............................................................................................................88 
3.1. 
Study Objectives .........................................................................................................88 
3.2. 
Study Outcome Measures ...........................................................................................88 
3.2.1. 
Primary Endpoints ......................................................................................................88 
3.2.2. 
Secondary Endpoints ..................................................................................................89 
4. 
STUDY DESIGN .......................................................................................................89 
5. 
STUDY ENROLLMENT AND WITHDRAWAL ....................................................91 
5.1. 
Subject Inclusion Criteria ...........................................................................................91 


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5.2. 
Subject Exclusion Criteria ..........................................................................................93 
5.3. 
Treatment Assignment Procedures .............................................................................94 
5.3.1. 
Randomization Procedures .........................................................................................94 
5.3.2. 
Masking Procedures ....................................................................................................95 
5.3.3. 
Reasons for Withdrawal .............................................................................................95 
5.3.4. 
Handling of Withdrawals ............................................................................................96 
5.3.5. 
Lost to Follow-up .......................................................................................................96 
5.3.6. 
Termination of Study ..................................................................................................96 
6. 
STUDY PRODUCTS .................................................................................................96 
6.1. 
Description of Study Products ....................................................................................96 
6.2. 
Acquisition ..................................................................................................................97 
6.3. 
Formulation, Packaging, and Labeling .......................................................................97 
6.4. 
Product Storage and Stability .....................................................................................97 
6.5. 
Dosage, Preparation and Administration ....................................................................98 
6.6. 
Accountability Procedures for the Study Products .....................................................98 
6.7. 
Assessment of Subject Compliance with Study Product ............................................99 
6.8. 
Concomitant Medications ...........................................................................................99 
7. 
STUDY PROCEDURES ............................................................................................99 
7.1. 
Medical History and COVID-19 Instruction ..............................................................99 
7.2. 
Physical Examination ...............................................................................................100 
7.3. 
Vital Signs ................................................................................................................100 
7.4. 
Electrocardiogram .....................................................................................................101 
7.5. 
Laboratory Evaluations .............................................................................................101 
7.5.1. 
Screening Laboratory Tests ......................................................................................101 
7.5.1.1. 
Viral Serology Testing ..............................................................................................101 
7.5.1.2. 
Drug Screen ..............................................................................................................101 
7.5.1.3. 
Pregnancy Testing ....................................................................................................101 
7.5.1.4. 
Screening Laboratory Tests ......................................................................................101 
7.5.2. 
Safety Laboratory Tests ............................................................................................102 
7.5.3. 
Hypersensitivity Panel ..............................................................................................102 


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7.6. 
Special Assays or Procedures ...................................................................................103 
7.6.1. 
Pharmacokinetic Assay .............................................................................................103 
7.6.2. 
Microneutralization Assay ........................................................................................103 
7.6.3. 
Immunogenicity / Anti-Drug Antibody Assay .........................................................103 
7.6.4. 
RT-PCR Testing for SARS-CoV-2 ..........................................................................103 
7.6.5. 
Future Use .................................................................................................................103 
7.6.6. 
Specimen Preparation, Handling, and Shipping .......................................................103 
8. 
STUDY SCHEDULE ...............................................................................................105 
8.1. 
Visit 1: Screening (Day -14 to Day -2) .....................................................................105 
8.2. 
Visit 2: Baseline / Day of Dosing (Day 1) ................................................................106 
8.3. 
Visit 3: Discharge from Unit (Day 2) .......................................................................108 
8.4. 
Visit 4: Out-patient Follow-up (Day 3) ....................................................................109 
8.5. 
Visit 5: Out-patient Follow-up (Day 4) ....................................................................109 
8.6. 
Visit 6: Out-patient Follow-up (Day 8± 2) ...............................................................109 
8.7. 
Visit 7: Out-patient Follow-up (Day 15± 2) .............................................................110 
8.8. 
Visit 8: Out-patient Follow-up (Day 30 ± 2) ............................................................110 
8.9. 
Visit 9: Out-patient Follow-up (Day 45± 3) .............................................................111 
8.10. 
Visit 10: Out-patient Follow-up (Day 60 ± 3) ..........................................................111 
8.11. 
Visit 11: Out-patient Follow-up (Day 90±3) ............................................................112 
8.12. 
Visit 12: Out-patient Follow-Up (Day 120±5) .........................................................112 
8.13. 
Visit 13: Out-patient Follow-Up (Day 150±5) .........................................................113 
8.14. 
Visit 14: Out-patient Follow-Up (Day 180±5) .........................................................113 
8.15. 
Visit 15: Day 365 ±5 /  Early Termination ...............................................................114 
8.16. 
Visit 16: Telephone Visit (Day 450 ±5) for Cohorts 1-4 ..........................................114 
8.17. 
Visit 17: Telephone Visit (Day 540 ±5) for Cohorts 1-4 ..........................................114 
8.18. 
Unscheduled Visit .....................................................................................................114 
9. 
ASSESSMENT OF SAFETY ...................................................................................115 
9.1. 
Specification of Safety Parameters ...........................................................................115 
9.2. 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters .................................................................................................................116 
9.2.1. 
Adverse Events .........................................................................................................116 


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9.2.2. 
Relationship to Study Product ..................................................................................116 
9.3. 
Reporting Procedures ................................................................................................117 
9.3.1. 
Adverse Events: ........................................................................................................117 
9.3.2. 
Serious Adverse Events ............................................................................................117 
9.3.3. 
Regulatory Reporting ................................................................................................118 
9.3.4. 
Reporting of Pregnancy ............................................................................................119 
9.4. 
Type and Duration of Follow-up of Subjects after Adverse Events .........................119 
9.5. 
Halting Rules ............................................................................................................119 
9.5.1. 
Halting Criteria for the Study ...................................................................................119 
9.5.2. 
Dose Escalation Halting Criteria ..............................................................................120 
9.5.3. 
Evaluation of Dose Escalation ..................................................................................120 
9.6. 
Safety Oversight .......................................................................................................120 
9.6.1. 
Independent Safety Monitor (ISM) ..........................................................................120 
9.6.2. 
ICON Medical Monitor ............................................................................................120 
9.6.3. 
Resilience Government Services Medical Lead .......................................................120 
9.6.4. 
Safety Review Committee (SRC) .............................................................................121 
10. 
CLINICAL MONITORING .....................................................................................121 
10.1. 
Site Monitoring Plan .................................................................................................121 
11. 
STATISTICAL CONSIDERATIONS .....................................................................122 
11.1. 
Sample Size Considerations .....................................................................................122 
11.2. 
Planned Interim Analyses .........................................................................................122 
11.3. 
Final Analysis Plan ...................................................................................................122 
11.3.1. 
Analysis Populations ................................................................................................122 
11.3.2. 
Demographics and Baseline Characteristics .............................................................123 
11.3.3. 
Safety Analysis Plan .................................................................................................123 
11.3.3.1. 
Adverse and Serious Adverse Events .......................................................................123 
11.3.3.2. 
Additional Safety Analyses ......................................................................................123 
11.3.4. 
PK Analysis Plan ......................................................................................................123 
11.3.5. 
Immunogenicity ........................................................................................................124 
11.3.6. 
Missing values and outliers ......................................................................................124 


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12. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS .............................................................................................125 
13. 
QUALITY CONTROL AND QUALITY ASSURANCE .......................................125 
14. 
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................125 
14.1. 
Ethical Standard ........................................................................................................125 
14.2. 
Institutional Review Board .......................................................................................126 
14.3. 
Informed Consent Process ........................................................................................126 
14.3.1. 
Informed Consent .....................................................................................................126 
14.4. 
Exclusion of Women, Minorities, and Children (Special Populations) ....................127 
14.5. 
Subject Confidentiality .............................................................................................127 
14.6. 
Study Discontinuation ..............................................................................................128 
14.7. 
Future Use of Stored Specimens ...............................................................................128 
15. 
DATA HANDLING AND RECORD KEEPING ....................................................128 
15.1. 
Data Management Responsibilities ..........................................................................129 
15.2. 
Data Capture Methods ..............................................................................................129 
15.3. 
Types of Data ............................................................................................................129 
15.4. 
Timing/Reports .........................................................................................................129 
15.5. 
Study Records Retention ..........................................................................................129 
15.6. 
Protocol Deviations ..................................................................................................129 
16. 
PUBLICATION POLICY ........................................................................................130 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................132 
APPENDIX B: CTCAE V5.0 ......................................................................................................135 
APPENDIX C: INTRAMUSCULAR (IM) ADMINISTRATION .............................................136 
 
 
 


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LIST OF ABBREVIATIONS 
ADA 
Anti-Drug Antibody 
ADE 
Antibody-dependent enhancement 
AE 
Adverse Event/Adverse Experience 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC 
Area Under the Curve 
BMI 
Body Mass Index 
BP 
Blood Pressure 
Bpm 
Beats per Minute 
BUN 
Blood Urea Nitrogen 
CAR 
Clinical Agents Repository 
CBC 
Complete Blood Count 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CHO 
Chinese hamster ovary 
Cmax 
Maximum Plasma Titer/Concentration 
CPM  
Clinical Project Manager 
CROMS 
Clinical Research Operations and Management Support 
CTCAE 
Common Terminology Criteria for Adverse Events version 5.0 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DMP 
Data Management Plan 
DOD 
Department of Defense 
eCRF 
Electronic Case Report Form 
ECG  
Electrocardiogram 
EDC 
Electronic Data Capture 
ECLA 
Electrochemiluminescence Assay 
ELISA 
Enzyme-Linked Immunosorbent Assay 


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FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act 
FESAP 
Federal Experts Advisory Panel 
FWA 
Federal Wide Assurance 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
Gm 
Gram 
gm/dL 
Grams per Deciliter 
HBsAg 
Hepatitis B Surface Antigen 
HCG 
Human Chorionic Gonadotropic Hormone 
HCV 
Hepatitis C Virus 
HED 
Human Equivalent Dose 
HEENT 
Head, Eyes, Ears, Nose and Throat 
HIV 
Human Immunodeficiency Virus 
HR 
Heart Rate 
Hr/hr 
Hour 
HRPO 
Human Research Protections Office 
HRSA 
Health Resources and Services Administration 
ICH 
International Conference on Harmonisation 
IDES 
Internet Data Entry System 
IEC 
Independent or Institutional Ethics Committee 
IgG 
Immunoglobulin G 
IHC 
Immunohistochemistry 
IM 
Intramuscular 
IND 
Investigational New Drug  
IP 
Intraperitoneal  
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 


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IUDs 
Intrauterine Contraceptive Device 
IV 
Intravenous 
IVIG 
Intravenous Immune Globulin 
KG 
Kilogram 
LLN 
Lower Limit of Normal 
mAbs/mAb 
Monoclonal Antibodies 
MedDRA 
Medical Dictionary for Regulatory Activities 
mEq/L 
Milliequivalent per Liter 
Mg/mg 
Milligram/milligram 
mg/dl 
Milligram per Deciliter 
ML 
Medical Lead 
Ml/mL 
Milliliter 
Mm/mm 
Millimeter 
mmHg 
Millimeters of Mercury 
MN 
Microneutralization 
MOP 
Manual of Procedures 
MPA 
Mouse Potency Assay 
MRSD 
Maximum Recommended Starting Dose 
N 
Number  
NIAID 
National Institute of Allergy and Infectious Diseases 
NIH 
National Institutes of Health 
NLM 
National Library of Medicine 
NOAEL 
No-Observed-Adverse-Effect-Level 
NSAIDS 
Nonsteroidal Anti-Inflammatory Drugs 
OHRP 
Office for Human Research Protections 
OTC 
Over the Counter 
PE 
Physical Examination 
PI 
Principal Investigator 
PK 
Pharmacokinetic(s) 


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PR 
PR Interval-Standard ECG Terminology 
PREP 
Public Readiness and Emergency Preparedness 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
PVG 
Pharmacovigilance Group 
PVSS 
Pharmacovigilance Safety System 
RBC/HPF 
Red Blood Cells per High-Power Field 
SAE 
Serious Adverse Event 
SRC 
Safety Review Committee 
SOP 
Standard Operating Procedure 
TIG 
Tetanus Immune Globulin 
Tmax 
Time to Maximum Concentration 
TTD 
Time to Death 
µg 
Microgram 
ULN 
Upper Limit of Normal 
VZIG 
Varicella Zoster Immune Globulin 
WBC 
White Blood Count 
 
 


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SUMMARY OF CHANGES FOR VERSION 7.0 
Version 6.0 
06 Jul 2022 
Version 7.0 
08 Aug 2023 
Reason for Change 
Ology Bioservices, Inc./Ology 
Bioservices/Ology Bio 
Resilience Government 
Services, Inc./Resilience 
Government Services/RGS 
Administrative change due to 
acquisition of Ology 
Bioservices, Inc. by Resilience 
Government Services, Inc. 
Page 71: Protocol Summary: 
Study Duration 
Approximately 18 months 
Page 74: Protocol Summary: 
Study Duration 
Approximately 18 months for 
cohorts 1-4 and 12 months for 
cohort 5 
Reduction in study follow-up 
from 18-months to 12-months 
for cohort 5 
Page 71: Protocol Summary: 
Subject Participation  
Subjects in all cohorts will 
participate approximately 554 
days (up to a 14-day screening, 
overnight stay, up to 12-month 
outpatient follow-up visits and 
telephone visits at 15-months 
and 18-months.) 
Page 74: Protocol Summary: 
Subject Participation  
Subjects in cohorts 1-4 will 
participate approximately 554 
days (up to a 14-day screening, 
overnight stay, up to 12-month 
outpatient follow-up visits and 
telephone visits at 15-months 
and 18-months.) 
 
Subjects in cohort 5 will 
participate approximately 379 
days (up to a 14-day screening, 
overnight stay, and up to 12-
month outpatient follow-up 
visits.) 
Reduction in study follow-up 
from 18-months to 12-months 
for cohort 5 


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Version 6.0 
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Reason for Change 
Page 73: Protocol Summary: 
Study Design 
Cohort 5 (600 mg IM injection) 
will enroll two sentinel subjects 
(one ADM03820 and one 
placebo) and each will be 
administered two 3 mL IM 
injections.  Dosing for the 
remaining subjects in Cohort 5 
will be initiated after at least 48 
hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.  
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 365.  
Subjects will have follow-up 
telephone visits at Days 450 and 
540. 
 
The study will consist of a 
fourteen-day screening period.  
The end of the study is defined 
as the date of the last visit of the 
last subject in the study (day 
540) 
 
Page 76-77: Protocol Summary: 
Study Design 
Cohort 5 (600 mg IM injection) 
will enroll two sentinel subjects 
(one ADM03820 and one 
placebo) and each will be 
administered two 3 mL IM 
injections.  Dosing for the 
remaining subjects in Cohort 5 
will be initiated after at least 48 
hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.  
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 365.   
 
The study will consist of a 
fourteen-day screening period.  
The end of the study is defined 
as the date of the last visit of the 
last subject in the study (day 540 
for cohorts 1-4 and day 365 for 
cohort 5) 
 
Reduction in study follow-up 
from 18-months to 12-months 
for cohort 5 


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Reason for Change 
Page 87: Study Design 
Subjects in all cohorts will 
participate in the study for 
approximately 554 days, 
including a 14-day screening 
period.  All subjects in the study 
will have a 24-hour stay in the 
clinic after dosing is complete to 
ensure that no hypersensitivities 
or safety signals occur.  Follow-
up outpatient visits will occur on 
Days 3, 4, 8, 15, 30, 45, 60, 
90,120, 150, 180, and 365 with 
telephone visits on Days 450 
and 540. The last outpatient 
follow up visit is scheduled at 
Day 365.  The end of the study 
is defined as the date of the last 
visit of the last subject in the 
study. 
 
Page 90: Study Design 
Subjects in cohorts 1-4 will 
participate in the study for 
approximately 554 days, 
including a 14-day screening 
period. Subjects in cohort 5 will 
participate in the study for 
approximately 379 days, 
including a 14-day screening 
period. All subjects in the study 
will have a 24-hour stay in the 
clinic after dosing is complete to 
ensure that no hypersensitivities 
or safety signals occur.  Follow-
up outpatient visits for all 
cohorts will occur on Days 3, 4, 
8, 15, 30, 45, 60, 90,120, 150, 
180, and 365 with cohorts 1-4 
having additional telephone 
visits on Days 450 and 540. The 
last outpatient follow up visit is 
scheduled at Day 365.  The end 
of the study is defined as the 
date of the last visit of the last 
subject in the study. 
 
Reduction in study follow-up 
from 18-months to 12-months 
for cohort 5 
Page 129-131: Schedule of 
Events 
Visit 16 & 17 TC 
Page 132-134: Schedule of 
Events 
Visit 16 & 17 TC for only 
Cohorts 1-4 
Reduction in study follow-up 
from 18-months to 12-months 
for cohort 5 


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SUMMARY OF CHANGES FOR VERSION 6.0 
Version 5.0 
22 Jun 2022 
Version 6.0 
06 Jul 2022 
Reason for Change 
Page 3: Signature Page 
 
Page 3: Signature Page 
 
Sponsor: Wael El-Amin, MD / 
Medical Lead 
Updated Medical Lead 
Page 12: List of Abbreviations 
Page 11: List of Abbreviations 
 
ML: Medical Lead 
Added Medical Lead 
abbreviation 
Page 56: Protocol Summary 
 
A total of 40 healthy male and 
female subjects between 18 – 55 
years of age 
Page 70: Protocol Summary 
 
A total of 50 healthy male and 
female subjects between 18 – 55 
years of age 
Addition of Cohort 5 
Page 57: Protocol Summary: 
Study Endpoints: Secondary 
Endpoints  
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for each of the 
monoclonal antibodies  of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) for samples from 
Cohort 3 and Cohort 4. 
 
 
 
Page 71: Protocol Summary: 
Study Endpoints: Secondary 
Endpoints 
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for each of the 
monoclonal antibodies  of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) for samples from 
Cohort 3, Cohort 4, and 
Cohort 5. 
 
Addition of Cohort 5 


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Page 57: Protocol Summary: 
Study Design 
 
This study is a phase 1, 
randomized, double-blind, 
placebo-controlled study of four 
dose cohorts.  The study will 
randomize a total of 40 healthy 
subjects to receive an 
intramuscular (IM) injection of 
either ADM03820 or placebo.   
 
Dosing Cohorts: 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 4 – 300 mg IM 
injection (8 active, 2 
placebo) 
 
Page 71: Protocol Summary: 
Study Design 
 
This study is a phase 1, 
randomized, double-blind, 
placebo-controlled study of five 
dose cohorts.  The study will 
randomize a total of 50 healthy 
subjects to receive an 
intramuscular (IM) injection of 
either ADM03820 or placebo.   
 
Dosing Cohorts: 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 4 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 5 – 600 mg IM 
Injection (8 active, 2 
placebo) 
 
Addition of Cohort 5 
Page 58: Protocol Summary: 
Study Design 
 
Dose escalation to Cohort 2 will 
not occur until safety data 
through day 8 for Cohort 1 is 
reviewed by the Safety Review 
Committee (SRC), which is 
composed of the Principal 
Investigator (PI), RGS Medical 
Monitor, and ICON Medical 
Monitor.  Objective dose 
escalation criteria and safety 
evaluations will be utilized. 
 
Page 72: Protocol Summary: 
Study Design 
 
Dose escalation to Cohort 2 will 
not occur until safety data 
through day 8 for Cohort 1 is 
reviewed by the Safety Review 
Committee (SRC), which is 
composed of the Principal 
Investigator (PI), RGS Medical 
Lead (ML), and ICON Medical 
Monitor.  Objective dose 
escalation criteria and safety 
evaluations will be utilized. 
Updated to include Medical 
Lead 


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Page 58: Protocol Summary: 
Study Design 
 
Page 72: Protocol Summary: 
Study Design 
 
Cohort 5 (600 mg IM injection) 
will enroll two sentinel subjects 
(one ADM03820 and one 
placebo) and each will be 
administered two 3 mL IM 
injections.  Dosing for the 
remaining subjects in Cohort 5 
will be initiated after at least 48 
hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.  
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 365.  
Subjects will have follow-up 
telephone visits at Days 450 and 
540. 
Addition of Cohort 5 


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Page 58: Protocol Summary: 
Study Design 
 
There are several blinded 
interim analyses planned for this 
study.   
• 
A blinded interim 
analysis is planned to 
analyze all PK samples 
through Day 30 for all 
subjects in Cohorts 1 
and 2.   
• 
A second blinded 
interim analysis is 
planned to analyze all 
PK samples after all 
subjects in Cohorts 1-3 
complete Day 60. 
There is also an interim clinical 
study report (CSR) planned after 
all subjects in all cohorts 
complete Day 90. 
Page 73: Protocol Summary: 
Study Design 
 
There are several blinded 
interim analyses planned for this 
study.   
• 
A blinded interim 
analysis is planned to 
analyze all PK samples 
through Day 30 for all 
subjects in Cohorts 1 
and 2.   
• 
A second blinded 
interim analysis is 
planned to analyze all 
PK samples after all 
subjects in Cohorts 1-3 
complete Day 60. 
• 
A third interim analysis 
is planned to analyze 
safety and PK after all 
subjects in cohort 5 
complete Day 60. 
There is also an interim clinical 
study report (CSR) planned after 
all subjects in Cohorts 1 through 
4 complete Day 90. 
Addition of third interim 
analysis and updated interim 
CSR to include Cohorts 1-4 
Page 60: Protocol Summary: 
Exclusion Criteria 
15. Positive serology results for 
SARS-CoV-2 antibodies 
 
Page 74-75: Protocol Summary: 
Exclusion Criteria 
15. Positive serology results for 
SARS-CoV-2 antibodies (Not 
applicable for Cohort 5). 
 
Updated exclusion criteria to not 
applicable to Cohort 5 


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Page 61: Protocol Summary: 
Exclusion Criteria 
 
24. Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit). 
Page 75: Protocol Summary: 
Exclusion Criteria 
 
24. Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit). 
For Cohort 5, subjects who 
received a COVID-19 vaccine 
within 14 days prior to 
enrollment are excluded. 
Updated exclusion criteria to not 
applicable to Cohort 5 
Page 62: Assess Eligibility 
Figure 
Page 76: Assess Eligibility 
Figure 
 
Cohort 5 N=10 (600 mg dose) 
Two 3 mL IM injection of 
ADM03820 (8 subjects) or 
Placebo (2 subjects) 
Addition of Cohort 5 to figure 
Page 63: Key Roles 
 
RGS Medical Monitor:  
John Abernethy, MD 
RGS, Inc. 
13200 NW Nano Court 
Alachua, FL 32615 
Telephone:  352-213-5757 
Email:  
john.abernethy@resilience.com 
Page 77: Key Roles 
 
RGS Medical Lead: Wael El-
Amin, MD 
RGS, Inc. 
13200 NW Nano Court 
Alachua, FL 32615 
Telephone:   240-885-1221 
Email:   wael.el-
amin@resilience.com 
Updated Medical Lead 
Page 65: Introduction 
 
As of August 10, 2020, 19.9 
million cases and 6.3 million 
deaths attributed to COVID-19 
have been reported globally, 
with 13 million cases and 
65,000 deaths in the US. 
Page 79: Introduction 
 
As of June 24, 2022, 539 million 
cases and 6.3 million deaths 
attributed to COVID-19 have 
been reported globally, with 
85.5 million cases and 1 million 
deaths in the US. 
Updated introduction 


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Page 66-67: Currently Available 
Treatments 
There are currently no FDA-
approved treatments for or 
vaccines against COVID-19, nor 
are there any for SARS or 
MERS. On May 1, 2020 the 
FDA issued an Emergency Use 
Authorization (EUA) for the 
investigational antiviral drug 
remdesivir for the treatment of 
suspected or laboratory 
confirmed COVID-19 in adults 
and children hospitalized with 
severe disease. While there is 
limited information known 
about the safety and 
effectiveness of using 
remdesivir to treat people in the 
hospital with COVID-19, the 
investigational drug was shown 
in a clinical trial to shorten the 
time to recovery in some 
patients.  
On December 11, 2020 the FDA 
issued the first EUA for a 
vaccine for the prevention of 
COVID-19 caused by SARS-
CoV-2. The EUA allows the 
Pfizer-BioNTech COVID-19 
Vaccine to be distributed in the 
U.S. for use in individuals 16 
years of age and older as a series 
of two doses that are given three 
weeks apart.  The most 
commonly reported side effects, 
which typically lasted several 
days were pain at the injection 
site, tiredness, headache, muscle 
pain, joint pain, and fever. 
On December 18, 2020 the FDA 
issued an EUA for the second 
vaccine for the prevention of 
COVID-19 caused by SARS-
CoV-2.  The EUA allows the 
Moderna COVID-19 Vaccine to 
Page 81: Currently Available 
Treatments 
 
At the initiation of this protocol, 
there were no FDA-approved 
treatments for or vaccines 
against COVID-19, nor were 
there any for SARS or MERS. 
On May 1, 2020 the FDA issued 
an Emergency Use 
Authorization (EUA) for the 
investigational antiviral drug 
remdesivir for the treatment of 
suspected or laboratory 
confirmed COVID-19 in adults 
and children hospitalized with 
severe disease. While there is 
limited information known 
about the safety and 
effectiveness of using 
remdesivir to treat people in the 
hospital with COVID-19, the 
investigational drug was shown 
in a clinical trial to shorten the 
time to recovery in some 
patients.  
Currently, there are multiple 
vaccines for the protection 
against and several mAbs 
available for the treatment and 
prophylaxis of COVID-19 that 
are available under emergency 
use authorization. 
Updated currently available 
treatment  


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be distributed in the U.S for use 
in individuals 18 years of age 
and older administered as a 
series of two doses that are 
given one month apart.  The 
most commonly reported side 
effects, which typically lasted 
several days were pain at the 
injection site, tiredness, 
headache, muscle pain, chills, 
joint pain, swollen lymph nodes 
in the same arm as the injection, 
nausea and vomiting, and fever. 
A global push to identify 
potential treatments has resulted 
in registration of a significant 
number of clinical trials for 
COVID-19 worldwide. Per 
ClinicalTrials.gov, there are 
currently 1645 interventional 
studies, including chloroquine 
and hydroxychloroquine; 
antivirals (e.g., remdesivir); 
antibiotics (e.g., azithromycin); 
steroids (e.g., dexamethasone); 
non-steroidal anti-inflammatory 
drugs (e.g., naproxen); 
angiotensin II receptor blockers 
(e.g., losartan); small molecule 
inhibitors (e.g., baricitinib); 
dietary supplements (e.g., 
vitamin D); biological products, 
including various monoclonal 
antibodies, cell therapies, and 
blood products; other drugs 
(e.g., colchicine); and medical 
devices (e.g., hyperbaric oxygen 
therapy). 


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Page 68: ADM03820 
Development 
 
A GLP repeat dose toxicity 
study is being performed to 
evaluate the safety of 
ADM03820 in rats when 
administered by intramuscular 
injection or intravenous infusion 
once weekly for three weeks and 
to evaluate toxicity and 
reversibility of effects after a 72-
day recovery period.   
Page 82: ADM03820 
Development 
 
A GLP repeat dose toxicity 
study was performed to evaluate 
the safety of ADM03820 in rats 
when administered by 
intramuscular injection or 
intravenous infusion once 
weekly for three weeks and to 
evaluate toxicity and 
reversibility of effects after a 72-
day recovery period.   
Updated ADM03820 
development 
Page 69: Rationale for Use of 
ADM03820 
 
The proposed starting dose for 
ADM03820 dose escalation 
(150 mg IM) is based on 
previous toxicology studies, 
known safety profile of mAbs, 
and the expected potency of 
ADM03820. Based on the 
expected potency of 
ADM03820, the doses proposed 
for evaluation are anticipated to 
support PK analysis with 
microneutralization values 
(TCID50) in therapeutic window 
for a prophylactic.  Provided 
there are no safety concerns, 
dosing will escalate to 300 mg 
IM. 
Page 84: Rationale for Use of 
ADM03820 
 
The proposed starting dose for 
ADM03820 dose escalation 
(150 mg IM) is based on 
previous toxicology studies, 
known safety profile of mAbs, 
and the expected potency of 
ADM03820. Based on the 
expected potency of 
ADM03820, the doses proposed 
for evaluation are anticipated to 
support PK analysis with 
microneutralization values 
(TCID50) in therapeutic window 
for a prophylactic.  Provided 
there are no safety concerns, 
dosing will escalate to 300 mg 
and 600 mg IM. 
Updated rationale for use of 
ADM03820 


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Page 71: Secondary Endpoints 
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for each of the 
monoclonal antibodies  of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) for samples from 
Cohort 3 and Cohort 4. 
 
 
 
Page 84-85: Secondary 
Endpoints 
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for each of the 
monoclonal antibodies  of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) for samples from 
Cohort 3, Cohort 4, and 
Cohort 5. 
 
Addition of Cohort 5 


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Page 72: Study Design 
 
This is a Phase 1, randomized, 
double-blind, placebo-controlled 
study of four dose cohorts to 
evaluate the safety, tolerability, 
and immunogenicity of 
ADM03820 in healthy adults. 
This is a first-in-human study 
and each subject will receive a 
single dose of ADM03820 or 
placebo.   
 
The study will randomize a total 
of 40 healthy subjects to receive 
an intramuscular (IM) injection 
of either ADM03820 or placebo.   
Table 1: Cohorts 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 4 – 300 mg IM 
injection (8 active, 2 
placebo) 
 
Page 86: Study Design 
 
This is a Phase 1, randomized, 
double-blind, placebo-controlled 
study of five dose cohorts to 
evaluate the safety, tolerability, 
and immunogenicity of 
ADM03820 in healthy adults. 
This is a first-in-human study 
and each subject will receive a 
single dose of ADM03820 or 
placebo.   
 
The study will randomize a total 
of 50 healthy subjects to receive 
an intramuscular (IM) injection 
of either ADM03820 or placebo.   
Table 1: Cohorts 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 4 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 5 – 600 mg IM 
Injection (8 active, 2 
placebo) 
 
Addition of Cohort 5 


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Page 72: Study Design 
 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK samples through Day 30 for 
all subjects in Cohorts 1 – 2.  A 
second blinded interim analysis 
is planned to analyze all PK 
samples after all subjects in 
Cohorts 1-3 complete Day 60. 
There is also an interim clinical 
study report (CSR) planned after 
all subjects complete Day 90. 
Page 87: Study Design 
 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK samples through Day 30 for 
all subjects in Cohorts 1 – 2.  A 
second blinded interim analysis 
is planned to analyze all PK 
samples after all subjects in 
Cohorts 1-3 complete Day 60. A 
third interim analysis is planned 
to analyze safety and PK after 
all subjects in cohort 5 complete 
Day 60. 
There is also an interim clinical 
study report (CSR) planned after 
subjects in Cohorts 1 through 4 
complete Day 90. 
Addition of third interim 
analysis and updated interim 
CSR to include Cohorts 1-4 


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Page 72-73: Study Design: 
Schedule for Cohorts 
 
Since this is a first-in-human 
study, administration of the 
study products to subjects in 
cohorts 1 and 2 will occur to 
allow careful observation of 
individuals for adverse events.  
Two sentinel subjects within 
each cohort will be admitted and 
administered a dose on Day 1 to 
remain in the clinic until Day 2.  
The randomization scheme will 
be designed to ensure that one 
subject will receive ADM03820 
and the other will receive 
placebo.  The IM dosing of the 
remaining subjects within 
cohorts 1 and 2 will not be 
initiated until at least 48 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria, and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.   
The remaining subjects in 
cohorts 1 and 2 will be dosed at 
least four hours apart until all 
subjects in the cohort have been 
dosed.   An alternate subject will 
be admitted to the unit for each 
two-subject group. Dose 
escalation will not occur until 
safety data through Day 8 is 
reviewed by the SRC. 
Page 87: Study Design: 
Schedule for Cohorts 
 
Since this is a first-in-human 
study, administration of the 
study products to subjects in 
cohorts 1, 2 and 5 will occur to 
allow careful observation of 
individuals for adverse events.  
Two sentinel subjects within 
each cohort will be admitted and 
administered a dose on Day 1 to 
remain in the clinic until Day 2.  
The randomization scheme will 
be designed to ensure that one 
subject will receive ADM03820 
and the other will receive 
placebo.  The IM dosing of the 
remaining subjects within 
cohorts 1, 2, and 5 will not be 
initiated until at least 48 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria, and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.   
The remaining subjects within 
each specific cohort will be 
dosed at least four hours apart 
until all subjects in the cohort 
have been dosed.   An alternate 
subject will be admitted to the 
unit for each two-subject group. 
Dose escalation will not occur 
until safety data through Day 8 
is reviewed by the SRC. 
Addition of Cohort 5 


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Page 73: Study Design: 
Schedule for Cohorts 
 
Page 88: Study Design: 
Schedule for Cohorts 
 
In Cohort 5 (600 mg IM 
injection of drug product 
concentrated at 100mg/mL), two 
sentinel subjects (one 
ADM03820 and one placebo) 
will each be administered two 3 
mL IM injections.  Dosing for 
the remaining subjects in Cohort 
5 will be initiated after at least 
48 hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.   
The SRC will review safety data 
through day 8 for subjects in 
cohort 5 prior to the initiation of 
the phase 2 protocol. 
Addition of Cohort 5 
Page 73: Site Enrollment 
 
This study will enroll forty 
healthy male and female 
subjects ages 18 to 55 years old 
in four cohorts. 
Page 88: Site Enrollment 
 
This study will enroll fifty 
healthy male and female 
subjects ages 18 to 55 years old 
in five cohorts.   
Addition of Cohort 5 
Page 73: Site Enrollment 
Exemptions may be granted on 
Inclusion/Exclusion Criteria 
pending Medical Director 
Approval. 
Page 88: Site Enrollment 
Exemptions may be granted on 
Inclusion/Exclusion Criteria 
pending Medical Lead 
Approval. 
Updated to Medical Lead 


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Page 76: Protocol Summary: 
Exclusion Criteria 
 
15. Positive serology results for 
SARS-CoV-2 antibodies 
Page 90: Protocol Summary: 
Exclusion Criteria 
 
15. Positive serology results for 
SARS-CoV-2 antibodies (Not 
applicable for Cohort 5). 
 
Updated exclusion criteria to not 
applicable to Cohort 5 
Page 77: Protocol Summary: 
Exclusion Criteria 
 
24. Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit). 
Page 91: Protocol Summary: 
Exclusion Criteria 
 
24. Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit). 
For Cohort 5, subjects who 
received a COVID-19 vaccine 
within 14 days prior to 
enrollment are excluded. 
Updated exclusion criteria to not 
applicable to Cohort 5 
Page 77: Randomization 
Procedures 
 
This is a Phase 1 double-
blinded, placebo-controlled trial 
that will randomize subjects 
within four dosing cohorts to 
either active or placebo.  
Cohorts 1 and 2 
For cohorts 1 and 2, the first two 
subjects will be randomized in a 
1:1 fashion to active and placebo 
to ensure that one of the first 
two subjects receives active 
treatment and the other control.   
Page 91: Randomization 
Procedures 
 
This is a Phase 1 double-
blinded, placebo-controlled trial 
that will randomize subjects 
within five dosing cohorts to 
either active or placebo. 
Cohorts 1, 2, and 5 
For cohorts 1, 2, and 5, the first 
two subjects will be randomized 
in a 1:1 fashion to active and 
placebo to ensure that one of the 
first two subjects receives active 
treatment and the other control.   
Addition of Cohort 5 


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Page 77: Masking Procedures 
 
Whenever possible, the 
Investigator should first discuss 
the options with the ICON 
GPHS Medical Monitor and the 
RGS Medical Monitor or 
appropriately designated RGS 
personnel before unblinding the 
subject’s treatment assignment. 
Page 92: Masking Procedures 
 
Whenever possible, the 
Investigator should first discuss 
the options with the ICON 
GPHS Medical Monitor and the 
RGS ML or appropriately 
designated RGS personnel 
before unblinding the subject’s 
treatment assignment. 
Updated to include Medical 
Lead 
Page 79: Formulation, 
Packaging, and Labeling: 
ADM03820 
 
ADM03820 will be 
administered by intramuscular 
(IM) injection as follows: 150 
mg (1 x 3 mL IM injection) or 
300 mg (Group 3 as 2 x 3 mL 
IM injections or Group 4 as 1 x 
3mL IM injection). 
Page 94: Formulation, 
Packaging, and Labeling: 
ADM03820 
 
ADM03820 will be 
administered by intramuscular 
(IM) injection as follows: 150 
mg (Cohort 1 as 1 x 3 mL IM 
injection) or 300 mg (Cohorts 2 
and 3 as 2 x 3 mL IM injections 
or Cohort 4 as 1 x 3mL IM 
injection) or 600 mg (Cohort 5 
as 2 x 3 mL IM injections). 
Addition of Cohort 5 
Page 80: Formulation, 
Packaging, and Labeling: 
Placebo 
 
Placebo will be administered by 
intramuscular (IM) injection as 
follows: 150 mg (1 x 3 mL IM 
injection) or 300 mg (Group 3 as 
2 x 3 mL IM injections or Group 
4 as 1 x 3mL IM injection). 
Page 95: Formulation, 
Packaging, and Labeling: 
Placebo 
 
Placebo will be administered by 
intramuscular (IM) injection as 
follows: 150 mg (Cohort 1 as 1 
x 3 mL IM injection) or 300 mg 
(Cohorts 2 and 3 as 2 x 3 mL IM 
injections or Cohort 4 as 1 x 
3mL IM injection) or 600 mg 
(Cohort 5 as 2 x 3 mL IM 
injections). 
Addition of Cohort 5 
Page 80: Product Storage and 
Stability 
 
Cohorts 4 Only 
Page 95: Product Storage and 
Stability 
 
Cohorts 4 and 5 Only 
Addition of Cohort 5 


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Page 82: Concomitant 
Medications 
• 
H1 antihistamines (PRN 
use of H1 antihistamines 
may be acceptable after 
Medical 
Director/Medical 
Monitor approval) 
Page 96: Concomitant 
Medications 
• 
H1 antihistamines (PRN 
use of H1 antihistamines 
may be acceptable after 
Medical Lead/Medical 
Monitor approval) 
Updated to Medical Lead 
Page 88: Visit 1: Screening (Day 
-14 to Day -2) 
• 
Documentation that the 
subject has not received 
an FDA approved 
vaccine for COVID-19 
(Subjects may receive 
an approved COVID-19 
vaccine after completing 
their Day 90 visit). 
Page 103: Visit 1: Screening 
(Day -14 to Day -2) 
• 
Documentation that the 
subject has not received 
an FDA approved 
vaccine for COVID-19 
(Subjects may receive 
an approved COVID-19 
vaccine after completing 
their Day 90 visit). For 
Cohort 5, subjects who 
received a COVID-19 
vaccine within 14 days 
prior to enrollment are 
excluded. 
Addition of Cohort 5 
Page 96: Visit 14: Out-patient 
Follow-up (Day 180±5) 
• 
Counsel both men and 
women of childbearing 
potential on the 
avoidance of pregnancy 
(for subjects who 
withdraw from the study 
early) 
Page 111: Visit 14: Out-patient 
Follow-up (Day 180±5) 
• 
Counsel both men and 
women of childbearing 
potential on the 
avoidance of pregnancy 
 
 
Removed for subjects who 
withdraw from the study early 
Page 100: Serious Adverse 
Events 
SAE Hotline: 352-213-5757 
Page 115: Serious Adverse 
Events 
SAE Hotline: 240-885-1221 
Updated SAE Hotline phone 
number 


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Page 103: ICON Medical 
Monitor 
 
The ICON MM is responsible 
for liaising with RGS Medical 
Monitor to ensure that all 
medical concerns are 
communicated and will provide 
any potential pertinent medical 
communication update to the 
project team as needed. 
Page 118: ICON Medical 
Monitor 
 
The ICON MM is responsible 
for liaising with RGS ML to 
ensure that all medical concerns 
are communicated and will 
provide any potential pertinent 
medical communication update 
to the project team as needed. 
Updated to include Medical 
Lead 
Page 103: RGS Medical 
Monitor  
 
The RGS Medical Monitor will 
be the main point of contact for 
the ICON MM and the DOD for 
any safety-related questions or 
concerns.  The RGS MM will 
escalate any medical or safety 
concerns to the DOD as needed. 
The RGS MM will participate in 
the planned SRC meetings and 
can make a recommendation 
that the SRC be convened to 
review any safety concerns. 
Page 118: RGS Medical Lead 
 
The RGS ML will be the main 
point of contact for the ICON 
MM and the DOD for any 
safety-related questions or 
concerns.  The RGS ML will 
escalate any medical or safety 
concerns to the DOD as needed. 
The RGS ML will participate in 
the planned SRC meetings and 
can make a recommendation 
that the SRC be convened to 
review any safety concerns. 
Updated to include Medical 
Lead 
Page 103: Safety Review 
Committee (SRC) 
 
The SRC will be composed of:  
• 
PI, or designee  
• 
RGS ML  
• 
ICON Medical Monitor 
or designee; 
Page 118: Safety Review 
Committee (SRC) 
 
The SRC will be composed of:  
• 
PI, or designee  
• 
RGS Medical Monitor  
• 
ICON Medical Monitor 
or designee; 
Updated to include Medical 
Lead 


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Page 104: Sample Size 
Consideration 
 
This is a Phase 1 study first in 
humans with four dosing cohorts 
and no formal sample size 
calculations based on testing a 
statistical hypothesis were 
constructed. Sample sizes are 
consistent with this type of early 
phase study. Dosing groups of 
ten participants each, eight 
participants assigned the active 
group and two assigned to the 
control group for each cohort are 
practical and provide sufficient 
information for a total sample 
size of 40 for a Phase 1 trial 
primarily designed to assess 
safety. 
Page 119: Sample Size 
Consideration 
 
This is a Phase 1 study first in 
humans with five dosing cohorts 
and no formal sample size 
calculations based on testing a 
statistical hypothesis were 
constructed. Sample sizes are 
consistent with this type of early 
phase study. Dosing groups of 
ten participants each, eight 
participants assigned the active 
group and two assigned to the 
control group for each cohort are 
practical and provide sufficient 
information for a total sample 
size of 50 for a Phase 1 trial 
primarily designed to assess 
safety. 
Addition of Cohort 5 
Page 105: Planned Interim 
Analyses 
 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK samples through Day 30 for 
all subjects in Cohorts 1 and 2.  
A second blinded interim 
analysis is planned to analyze all 
PK samples after all subjects in 
cohorts 1-3 complete Day 60. 
 
There is also an interim clinical 
study report (CSR) planned after 
all subjects complete Day 90. 
Page 119: Planned Interim 
Analyses 
 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK samples through Day 30 for 
all subjects in Cohorts 1 and 2.  
A second blinded interim 
analysis is planned to analyze all 
PK samples after all subjects in 
cohorts 1-3 complete Day 60. A 
third interim analysis is planned 
to analyze safety and PK after 
all subjects in cohort 5 complete 
Day 60. 
 
There is also an interim clinical 
study report (CSR) planned after 
subjects in Cohorts 1 through 4 
complete Day 90. 
Addition of third interim 
analysis and updated interim 
CSR to include Cohorts 1-4 


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Version 6.0 
06 Jul 2022 
Reason for Change 
Page 116-117: Appendix A: 
Schedule of Events 
 
SARS-CoV-2 Antibodies 
Page 131-132: Appendix A: 
Schedule of Events 
 
SARS-CoV-2 Antibodies18 
. 18. SARS-CoV-2 antibodies will 
only be tested in Cohorts 1-4 
(Not applicable for Cohort 5).   
 
Updated to not applicable to 
Cohort 5 
Page 119: Appendix C: 
Intramuscular (IM) 
Administration  
Page 134: Appendix C: 
Intramuscular (IM) 
Administration 
 
Cohort 5 Only: IP is 
administered as two 3mL 
(600mg dose) IM injection 
within 30 minutes of removing 
from refrigerator. 
Addition of Cohort 5 
 


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Reason for Change 
Page 51 Protocol Summary 
Study Population = 30 
 
Page 56 Protocol Summary and 
Page 70 Study Design 
 
Study Population = 40 
Increased number of subjects by 
adding a cohort 
Page 51 Protocol Summary and 
Page 65 Study Outcome 
Measures  
 
Secondary Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total antibodies 
of ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) for samples from 
Cohorts 1 and 2. The assessment 
of Cmax, Tmax and AUC(0-t) for 
each of the monoclonal 
antibodies  of ADM03820 as 
measured by enzyme-linked 
immunosorbent assay (ELISA) 
for samples from Cohort 3. 
Page 56 Protocol Summary and 
Page 70 Study Outcome 
Measures  
 
Secondary Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total antibodies 
of ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) for samples from 
Cohorts 1 and 2. The assessment 
of Cmax, Tmax and AUC(0-t) for 
each of the monoclonal 
antibodies  of ADM03820 as 
measured by enzyme-linked 
immunosorbent assay (ELISA) 
for samples from Cohort 3 and 
Cohort 4. 
Performing testing on each of 
the monoclonal antibodies  of 
ADM03820 for cohort 3 and 
cohort 4 
Page 53 Protocol Summary 
Study Design and Page 66 Study 
Design 
 
Page 57 Protocol Summary 
Study Design and Page 71 Study 
Design 
 
Cohort 4 –300 mg IM injection 
(8 active, 2 placebo) 
 
Cohort  4 (300 mg IM injection) 
will enroll ten subjects without 
delay using 100 mg/mL drug 
product. 
Added cohort for 100mg/mL 
drug product 


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Page 53 Protocol Summary  
Study Design 
 
There are several blinded 
interim analyses planned for this 
study.   
• 
A blinded interim 
analysis is planned to 
analyze all PK samples 
through Day 30 for all 
subjects in Cohorts 1 
and 2.   
• 
A second blinded 
interim analysis is 
planned to analyze all 
PK samples after all 
subjects in all cohorts 
complete Day 60. 
 
Page 58 Protocol Summary 
Study Design and Page 71 Study 
Design 
 
There are several blinded 
interim analyses planned for this 
study.   
• 
A blinded interim 
analysis is planned to 
analyze all PK samples 
through Day 30 for all 
subjects in Cohorts 1 
and 2.   
• 
A second blinded 
interim analysis is 
planned to analyze all 
PK samples after all 
subjects in Cohorts 1-3 
complete Day 60. 
 
Specified the Day 60 interim 
analysis will analyze data for 
cohorts 1-3 
Page 57 Key Roles 
ICON Medical Monitor 
Kelly Struble, DO 
 
Page 62 Key Roles 
ICON Medical Monitor 
 
Change in ICON MM 


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Page 73 Study Products 
Description of Study Products 
 
ADM03820 is a 1:1 mixture of 
two human IgG1 non-
competitive anti-SARS-CoV-2 
antibodies  [mAb2130 
(YTE+LALA) and mAb2381 
(YTE+LALA)] formulated in 
141 mM L-arginine, 10 mM 
sodium succinate buffer, with 
0.25% v/v Polysorbate 80, and 
filled as 1.2 mL at 50 mg/mL in 
a 2 mL vial. The drug product is 
a clear, colorless, sterile aqueous 
solution at pH 6. 
Page 78 Study Products 
Description of Study Products 
 
ADM03820 is a 1:1 mixture of 
two human IgG1 non-
competitive anti-SARS-CoV-2 
antibodies formulated as 50 
mg/mL or 100 mg/mL strength 
solutions in a 2 mL vial for IM 
administration. The drug 
product is a clear to opalescent, 
slightly colored, sterile aqueous 
solution at pH 6. ADM03820 is 
formulated in 141 mM L-
arginine, 10 mM sodium 
succinate buffer, with 0.25% v/v 
Polysorbate 80 and is filled as 
1.2 mL in a 2 mL vial (50 
mg/mL) or 1.7 mL in a 2 mL 
vial (100 mg/mL).  
 
Added a 100mg/mL formulation 


Protocol: ADM03820-001 
Version 7.0 
 
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Page 74 Product Storage and 
Stability  
 
ADM03820 drug product will 
be shipped frozen and should be 
stored at -90°C to -70°C until 
time of preparation.  If a vial is 
removed from the freezer it must 
be used within 1 hour of 
thawing.  If not used, it must be 
quarantined and maintained for 
study product accountability as 
per Section 6.6. ADM03820 
should be protected from direct 
sunlight. ADM03820 is not light 
sensitive under normal shipping 
and storage conditions.  Avoid 
vigorous shaking or agitation. 
 
Page 78 Product Storage and 
Stability 
 
Cohorts 1-3 
ADM03820 drug product 
(50mg/mL) will be shipped 
frozen and should be stored at -
90°C to -70°C until time of 
preparation.  If a vial is removed 
from the freezer it must be used 
within 1 hour of thawing.  If not 
used, it must be quarantined and 
maintained for study product 
accountability as per Section 
6.6. ADM03820 should be 
protected from direct sunlight. 
ADM03820 is not light sensitive 
under normal shipping and 
storage conditions.  Avoid 
vigorous shaking or agitation. 
Cohort 4 Only 
ADM03820 (100mg/mL) drug 
product will be shipped and 
should be stored at 2°C to 8°C 
until time of preparation.  If a vial 
is removed from the refrigerator 
it must be used within 30 
minutes.  If not used, it must be 
quarantined and maintained for 
study product accountability as 
per Section 10.5. ADM03820 
should be protected from direct 
sunlight. ADM03820 is not light 
sensitive under normal shipping 
and storage conditions.  Avoid 
vigorous shaking or agitation. 
 
Added 100mg/mL drug product 
information 


Protocol: ADM03820-001 
Version 7.0 
 
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Page 78 Drug Screen 
 
A urine toxicology screen will 
be performed to detect for the 
presence of the following: 
cocaine (and metabolite), 
barbiturates, benzodiazepines, 
opiates, THC, 
methamphetamine/amphetamine
, methadone and PCP. The 
results must be negative for 
eligibility into the study.  A 
breathalyzer test or blood 
alcohol test will also be 
performed, and results must be 
negative for eligibility into the 
study. 
 
Page 83 Drug Screen  
A urine toxicology screen will 
be performed to detect for the 
presence of the following: 
cocaine (and metabolite), 
barbiturates, benzodiazepines, 
opiates, THC, 
methamphetamine/amphetamine
, methadone and PCP. The 
results must be negative for 
eligibility into the study.  A 
blood/saliva alcohol test will 
also be performed, and results 
must be negative for eligibility 
into the study. 
 
Allowing for blood/saliva 
alcohol test 


Protocol: ADM03820-001 
Version 7.0 
 
August 8, 2023 
Resilience Government Services 
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SUMMARY OF CHANGES FOR VERSION 4.0 
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Version 4.0 
02 Mar 2021 
Reason for Change 
Page 45 Protocol Summary 
Study Population = 185 
 
Page 51 Protocol Summary 
Study Population = 30 
 
Decrease number of subjects in 
the study 
Page 45 Protocol Summary  
Number of Site = 10 
Study Duration = 12 months 
Subject Participation = 379 days 
Page 51 Protocol Summary  
Number of Site = 5 
Study Duration = 18 months 
Subject Participation = 554 days 
Increase study participation 
duration to 18-months (554 
days) 
Page 45 Protocol Summary 
Secondary Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total antibodies 
of ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) methods 
designed for total monoclonal 
antibody in the Drug Product. 
 
Page 51 Protocol Summary 
Secondary Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total antibodies 
of ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) for samples from 
Cohorts 1 and 2. The assessment 
of Cmax, Tmax and AUC(0-t) for 
each of the monoclonal 
antibodies  of ADM03820 as 
measured by enzyme-linked 
immunosorbent assay (ELISA) 
for samples from Cohort 3. 
Performing testing on each of 
the monoclonal antibodies  of 
ADM03820 for cohort 3 only 
Page 46 Protocol Summary 
Study Design 
Cohort 3 –300 mg IM injection 
(110 active, 55 placebo) 
 
Page 48 Protocol Summary 
Study Design 
Cohort 3 –300 mg IM injection 
(8 active, 2 placebo) 
 
Decreased the number of 
subjects in cohort 3 
Page 47 Protocol Summary 
Study Design 
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 365.    
 
Page 48 Protocol Summary 
Study Design 
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 365.  
Subjects will have follow-up 
telephone visits at Days 450 and 
540.  
 
Increase study participation 
duration to 18-months (554 
days) 


Protocol: ADM03820-001 
Version 7.0 
 
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Page 47 Protocol Summary 
Study Design 
• 
There are several 
blinded interim analyses 
planned for this study.  
A blinded interim 
analysis is planned to 
analyze all PK and MN 
samples through Day 8 
for all subjects in 
Cohorts 1 – 3.  A second 
blinded interim analysis 
is planned to analyze all 
PK and MN samples 
after all subjects in all 
cohorts complete Day 
30. 
 
Page 49 Protocol Summary 
Study Design 
There are several blinded 
interim analyses planned for this 
study.   
• 
A blinded interim 
analysis is planned to 
analyze all PK and MN 
samples through Day 30 
for all subjects in 
Cohorts 1 and 2.   
• 
A second blinded 
interim analysis is 
planned to analyze all 
PK and MN samples 
after all subjects in all 
cohorts complete Day 
60. 
 
Revised plan for interim 
analysis 
Page 48 Protocol Summary 
Inclusion Criteria 
13. Breathalyzer test is negative 
and subject agrees to abstain 
from alcohol consumption 
for a period of 2 days prior 
to dosing and 2 days prior to 
any study visit. 
 
Page 50 Protocol Summary 
Inclusion Criteria 
13. Breathalyzer test or blood 
alcohol test is negative and 
subject agrees to abstain 
from alcohol consumption 
for a period of 2 days prior 
to dosing and 2 days prior to 
any study visit. 
Added blood alcohol test as an 
option for testing alcohol 
consumption  


Protocol: ADM03820-001 
Version 7.0 
 
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Reason for Change 
Page 59 Section 3.2.2 Secondary 
Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total 
monoclonal antibodies of 
ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) methods 
designed for total monoclonal 
antibody in the Drug Product. 
 
Page 61 Section 3.2.2 Secondary 
Endpoints 
The assessment of Cmax, Tmax 
and AUC(0-t) for total antibodies 
of ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) for samples from 
Cohorts 1 and 2. The assessment 
of Cmax, Tmax and AUC(0-t) for 
each of the monoclonal 
antibodies  of ADM03820 as 
measured by enzyme-linked 
immunosorbent assay (ELISA) 
for samples from Cohort 3. 
 
Performing testing on each of 
the monoclonal antibodies  of 
ADM03820 for cohort 3 only 
Page 60, Section 4 Study Design 
The study will randomize a total 
of 185 healthy subjects to 
receive an intramuscular (IM) 
injection of either ADM03820 
or placebo.   
 
Page 62, Section 4 Study Design 
The study will randomize a total 
of 30 healthy subjects to receive 
an intramuscular (IM) injection 
of either ADM03820 or placebo.   
 
Decreased the number of 
subjects in cohort 3 
Page 60 Schedule for Subjects 
Follow-up visits will occur on 
Days 3, 4, 8, 15, 30, 45, 60, 
90,120, 150, 180, and 365.The 
last follow up visit is scheduled 
at Day 365. 
Page 62 Schedule for Subjects 
Follow-up outpatient visits will 
occur on Days 3, 4, 8, 15, 30, 
45, 60, 90,120, 150, 180, and 
365 with telephone visits on 
Days 450 and 540. The last 
outpatient follow-up visit is 
scheduled at Day 365. 
Added telephone visits 


Protocol: ADM03820-001 
Version 7.0 
 
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Reason for Change 
Page 60 Schedule for Subjects 
A blinded interim analysis is 
planned to analyze all PK and 
MN samples through Day 8 for 
all subjects in Cohorts 1 – 3.  A 
second blinded interim analysis 
is planned to analyze all PK and 
MN samples after the first 100 
subjects complete Day 30.  A 
third blinded interim analysis is 
planned to analyze all PK and 
MD samples after all subjects in 
all cohorts complete Day 30. 
Page 62 Schedule for Subjects 
A blinded interim analysis is 
planned to analyze all PK and 
MN samples through Day 30 for 
all subjects in Cohorts 1 – 2.  A 
second blinded interim analysis 
is planned to analyze all PK and 
MN samples after all subjects in 
all cohorts complete Day 60. 
 
Revised plan for interim 
analysis 
Page 61 Section 5 Study 
Enrollment and Withdrawal 
No exemptions are granted on 
Inclusion/Exclusion Criteria. 
Page 63 Section 5 Study 
Enrollment and Withdrawal 
Exemptions may be granted on 
Inclusion/Exclusion Criteria 
pending Medical Director 
Approval. 
Allowed exceptions with 
approval 
Page 66 Section 5.3.4 Handling 
of Withdrawals 
Subjects that withdraw from 
cohort 3 after dosing will not be 
replaced. Subjects who withdraw 
or are withdrawn from the study 
who received any amount of the 
study product will be encouraged 
to continue follow-up (with 
subjects’ consent) for safety.  
Subjects withdrawing will be 
asked to complete a final 
termination visit if they do not 
wish to be followed per protocol. 
 
Page 68 Section 5.3.4 Handling 
of Withdrawals 
 
Removed language specific to 
cohort 3 
Withdrawal of subjects will be 
handled the same for all cohorts 
Page 68 Section 6.5 Dosage, 
Preparation and Administration 
 
The subjects will be admitted to 
the Phase 1 unit the day before 
the planned dosing.   
Page 70 Section 6.5 Dosage, 
Preparation and Administration 
 
The subjects will be admitted to 
the Phase 1 unit the day of the 
planned dosing.   
Admittance to the Phase 1 unit 
prior to day of dosing is not 
necessary 


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Page 69 Section 6.8 
Concomitant Medications 
• 
H1 antihistamines 
 
Page 71 Section 6.8 
Concomitant Medications 
• 
H1 antihistamines (PRN use 
of H1 antihistamines may be 
acceptable after Medical 
Director/Medical Monitor 
approval) 
 
Will allow PRN use of H1 
antihistamines upon approval 
No visit 16 
Page 86 Section 8.16 Visit 16 
Added telephone visit 
 
No visit 17 
Page 86 Section 8.17 Visit 17 
Added telephone visit 
Page 87 Section 9.2.1 Adverse 
Events 
Severity of adverse events will 
be graded as follows based on 
the Investigator’s assessment 
unless otherwise specified by 
CTCAE v5.0 (Appendix B).: 
Mild:  Events require minimal 
or no treatment and do not 
interfere with the subject’s daily 
activities. 
Moderate:  Events result in a 
low level of inconvenience or 
concern with therapeutic 
measures. Moderate events may 
cause some interference with 
functioning. 
Severe:  Events interrupt a 
subject’s usual daily activity and 
may require systemic drug 
therapy or other treatment.  
Severe events are usually 
incapacitating. 
 
Page 88 Section 9.2.1 Adverse 
Events 
Severity of adverse events will 
be graded using CTCAE v5.0 
(Appendix B). 
 
Removed mild, moderate, severe 
rating for AEs and added the use 
of CTCAE v5.0 for grading AEs 


Protocol: ADM03820-001 
Version 7.0 
 
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Page 93 Section 11.1 Sample 
Size Considerations 
Dosing groups of ten 
participants each, eight 
participants assigned the active 
group and two assigned to the 
control group for cohorts 1 and 
2, and a dosing group of one 
hundred sixty-five participants 
in cohort 3, one hundred ten 
participants assigned to the 
active group and fifty-five 
assigned to the control group are 
practical and provide sufficient 
information for a total sample 
size of 185 for a Phase 1 trial 
primarily designed to assess 
safety. 
 
Page 93 Section 11.1 Sample 
Size Considerations 
Dosing groups of ten 
participants each, eight 
participants assigned the active 
group and two assigned to the 
control group for each cohort are 
practical and provide sufficient 
information for a total sample 
size of 30 for a Phase 1 trial 
primarily designed to assess 
safety. 
 
Decreased the number of 
subjects in cohort 3 
Page 94 Section 11.3.4 PK 
Analysis Plan 
 
PK parameters will be estimated 
for total monoclonal antibodies 
using noncompartmental 
methods in WinNonlin or a 
similar software package. 
Page 95 Section 11.3.4 PK 
Analysis Plan 
 
PK parameters will be estimated 
for total antibodies of 
ADM03820 as measured by 
enzyme-linked immunosorbent 
assay (ELISA) for samples from 
Cohorts 1 and 2. PK parameters 
for each of the monoclonal 
antibodies  of ADM03820 as 
measured by enzyme-linked 
immunosorbent assay (ELISA) 
for samples from Cohort 3 using 
noncompartmental methods in 
WinNonlin or a similar software 
package. 
Performing testing on each of 
the monoclonal antibodies  of 
ADM03820 for cohort 3 only 
Page 103 Appendix A Schedule 
of Events 
 
Page 104 Appendix A Schedule 
of Events 
 
Added telephone visits 16 and 
17 
 


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Version 7.0 
 
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Version 3.0 
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Reason for Change 
Page 9 List of abbreviations 
Page 9 List of abbreviations – 
added CTCAE 
Protocol is using the CTCAE to 
replace the toxicity grading 
scale 
Page 25 Protocol Summary –  
Study Population = 40 subjects 
Page 41 Protocol Summary – 
Study Population = 185 subjects 
 Increased number of subjects 
Page 25 Protocol Summary –  
Number of Sites = 2 
Page 41 Protocol Summary - 
Number of Site = 10 
Increased number of sites to 
expedite enrollment 
Page 25 Protocol Summary –  
Study Duration = 18 months 
Page 41 Protocol Summary – 
Study Duration = 12 months 
Reduced the subject 
participation from 18-months to 
12-months 
Page 25 Protocol Summary –  
Subject Participation Duration =  
Subjects in all cohorts will 
participate approximately 554 
days (14 to a 14-day screening, 
overnight stay, up to 18-month 
outpatient follow) 
Page 41 Protocol Summary –  
Subject Participation Duration  
Subjects in all cohorts will 
participate approximately 379 
days (14 to a 14-day screening, 
overnight stay, up to 12-month 
outpatient follow) 
Reduced the subject 
participation from 18-months to 
12-months 
Page 25 Protocol Summary –  
Route of Delivery = Subjects 
will receive IM injections in the 
buttocks or an IV infusion over 
1 hour 
Page 41 Protocol Summary –  
Route of Delivery = Subjects 
will receive IM injections in the 
buttocks 
Removed IV infusion cohorts 
from this protocol 
Page 25 Protocol Summary –  
Study Endpoints 
o Secondary Endpoints = 
Pharmacokinetic 
samples will be tested 
by ELISA at pre-dose, 
2, 4, 8, and 24 hours 
post dose, and on Days 
3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, 360, 
and 540 for all cohorts 
Page 41 Protocol Summary –  
Study Endpoints 
o Secondary Endpoints = 
Pharmacokinetic 
samples will be tested 
by ELISA at pre-dose, 
2, 4, 8, and 24 hours 
post dose, and on Days 
3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, and 
365 for all cohorts 
 
Reduced the subject 
participation from 18-months to 
12-months 


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Page 25 Protocol Summary –  
Study Endpoints 
• 
Samples will be tested by 
Electrochemiluminescence 
Assay (ECLA)  to evaluate 
presence of anti-drug 
antibodies (ADA) collected 
for all cohorts. 
o ADA samples will be 
tested at pre-dose, and 
Day 15, 30, 45, 60, 90, 
120, 150, 180, 360 and 
540 for all cohorts 
Page 41 Protocol Summary –  
Study Endpoints 
• 
Samples will be tested by 
Electrochemiluminescence 
Assay (ECLA)  to evaluate 
presence of anti-drug 
antibodies (ADA) collected 
for all cohorts. 
o ADA samples will be 
tested at pre-dose, and 
Day 15, 30, 45, 60, 90, 
120, 150, 180, and 365 
for all cohorts 
Reduced subject participation 
from 18-months to 12-months 
Page 25 Protocol Summary –  
Study Endpoints 
Page 42 Protocol Summary –  
Study Endpoints 
 
• 
Incidence of the first case of 
SARS-CoV-2 RT-PCR 
positive symptomatic illness 
occurring after dosing 
through Day 365 
 
• 
Incidence of SARS-CoV-2 
RT-PCR positive severe or 
critical symptomatic illness 
occurring after dosing 
through Day 365 
 
• 
Incidence of COVID-19 
related Emergency 
Department visits occurring 
after dosing through Day 
365 
 
Added secondary endpoints 


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Page 26 Protocol Summary –  
Study Design –  
The study will randomize a total 
of 40 healthy subjects to receive 
either an intramuscular (IM) 
injection or intravenous (IV) 
infusion of either ADM03820 or 
placebo.   
Dosing Cohorts: 
 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –10 mg/kg IV 
infusion (8 active, 2 
placebo) 
• 
Cohort 4 – 20 mg/kg IV 
infusion (8 active, 2 
placebo) 
 
Page 42 Protocol Summary –  
Study Design -  
The study will randomize a total 
of 185 healthy subjects to 
receive an intramuscular (IM) 
injection of either ADM03820 
or placebo.   
Dosing Cohorts: 
 
• 
Cohort 1 –150 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 2 – 300 mg IM 
injection (8 active, 2 
placebo) 
• 
Cohort 3 –300 mg IM 
injection (110 active, 55 
placebo) 
 
Dosing for Cohort 3 (300 mg IM 
injection) will not occur until 
safety data through day 8 for 
Cohort 2 is reviewed by the 
SRC.  Objective safety 
evaluations will be utilized.  
Subjects in Cohort 3 will be 
scheduled based on the SRC 
recommendation and will each 
be administered two 3 mL IM 
injections without delay. 
Removed IV cohorts and revised 
cohort 3 to be IM injection 
cohort and dosing for cohort 3 
will not have the four-hour 
dosing restrictions that cohorts 1 
and 2 have. 


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Page 27 Protocol Summary –  
Study Design –  
A blinded interim safety and PK 
analysis is planned for this study 
to analyze all PK and MN 
samples through Day 30.  This 
will include all subjects in all 
cohorts through Day 30. 
 
Page 43 Protocol Summary –  
Study Design –  
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK and MN samples through 
Day 8 for all subjects in Cohorts 
1 – 3.  A second blinded interim 
analysis is planned to analyze all 
PK and MN samples after all 
subjects in all cohorts complete 
Day 30. 
There is also an interim clinical 
study report (CSR) planned after 
all subjects complete Day 90. 
Additional interim analysis 
added as well as an interim CSR 
Page 28 Protocol Summary –  
Exclusion Criteria –  
11.Donated blood within 56 
days of enrollment  
Page 45 Protocol Summary –  
Exclusion Criteria –  
11.Donated blood or plasma 
within 56 days of enrollment  
Added or plasma 
Page 28 Protocol Summary –  
Exclusion Criteria –  
 
Page 45 Protocol Summary –  
Exclusion Criteria –  
24.  Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit) 
Added exclusion  
Page 30 Schematic of Study 
Design 
Page 46 Schematic of Study 
Design 
Revised to three cohorts and 
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Page 34 Section 2.1.2 Currently 
Available Treatments 
Page 50 Section 2.1.2 Currently 
Available Treatments 
On December 11, 2020 the FDA 
issued the first EUA for a 
vaccine for the prevention of 
COVID-19 caused by SARS-
CoV-2. The EUA allows the 
Pfizer-BioNTech COVID-19 
Vaccine to be distributed in the 
U.S. for use in individuals 16 
years of age and older as a series 
of two doses that are given three 
weeks apart.  The most 
commonly reported side effects, 
which typically lasted several 
days were pain at the injection 
site, tiredness, headache, muscle 
pain, joint pain, and fever. 
On December 18, 2020 the FDA 
issued an EUA for the second 
vaccine for the prevention of 
COVID-19 caused by SARS-
CoV-2.  The EUA allows the 
Moderna COVID-19 Vaccine to 
be distributed in the U.S for use 
in individuals 18 years of age 
and older administered as a 
series of two doses that are 
given one month apart.  The 
most commonly reported side 
effects, which typically lasted 
several days were pain at the 
injection site, tiredness, 
headache, muscle pain, chills, 
joint pain, swollen lymph nodes 
in the same arm as the injection, 
nausea and vomiting, and fever. 
Added language to cover the 
approved Pfizer and Moderna 
COVID-19 vaccines 


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Page 36 Section 2.2 Rationale 
for Use of ADM03820 –  
The proposed starting dose for 
ADM03820 dose escalation 
(150 mg IM) is based on 
previous toxicology studies, 
known safety profile of mAbs, 
and the expected potency of 
ADM03820. Based on the 
expected potency of 
ADM03820, the doses proposed 
for evaluation are anticipated to 
support PK analysis with 
microneutralization values 
(TCID50) in therapeutic window 
for a prophylactic.  Provided 
there are no safety concerns, 
dosing will escalate to 300 mg 
IM. Provided there are no safety 
concerns with the 300 mg IM 
dosing, dosing will then escalate 
to 10 mg/kg IV infusion. 
Provided there are no safety 
concerns, dosing will escalate to 
20 mg/kg IV infusion.  
Page 53 Section 2.2 Rationale 
for Use of ADM03820 –  
The proposed starting dose for 
ADM03820 dose escalation 
(150 mg IM) is based on 
previous toxicology studies, 
known safety profile of mAbs, 
and the expected potency of 
ADM03820. Based on the 
expected potency of 
ADM03820, the doses proposed 
for evaluation are anticipated to 
support PK analysis with 
microneutralization values 
(TCID50) in therapeutic window 
for a prophylactic.  Provided 
there are no safety concerns, 
dosing will escalate to 300 mg 
IM.  
 
Removed IV dosing 


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Page 37 Section 2.3.1 Potential 
Risks 
IV Infusion of mAbs 
An indwelling catheter may 
cause phlebitis with signs of 
redness and warmth at or near 
the IV insertion site. 
Thrombophlebitis is also a 
potential risk with a hard area 
palpable near the IV insertion 
site. These risks are minimal as 
the infusion time is around one 
hour. There is the potential for 
infiltration of the study product 
into the tissues surrounding the 
IV site. Careful inspection of the 
site, including visualization of 
blood return at the catheter site 
will minimize this risk. There is 
a risk of infection; however, this 
is a small risk as aseptic 
technique will be employed. 
Infusions of mAbs may be 
associated with infusion 
reactions, including anaphylaxis/ 
anaphylactoid type reaction, 
especially during a first 
exposure, and when 
administered rapidly. Fever, 
chills, and rigors, typically 
occurring within the first 2 hours 
following infusion, characterize 
these reactions. Other risks 
sometimes associated with 
infusion reactions include 
nausea, vomiting, rash, pruritus, 
bronchospasm or other acute 
pulmonary response, 
angioedema, hypotension, 
hypertension, cardiac 
arrhythmias, dizziness, dyspnea, 
headache, and malaise. 
Page 54 Section 2.3.1 Potential 
Risks 
Removed risks associated with 
IV infusion 


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Page 39 Section 3.2.2 Secondary 
Endpoints 
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for total 
monoclonal antibodies of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) methods designed 
for total monoclonal 
antibody in the Drug 
Product. 
o Pharmacokinetic samples 
will be tested by ELISA 
at pre-dose, 2, 4, 8, and 
24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 
45, 60, 90, 120, 150, 180, 
360 and 540 for all 
cohorts 
o Samples will be tested by 
Microneutralization at 
pre-dose and Days 2, 15, 
30, 60, 90, 120, 150, and 
180 for all cohorts 
• 
Samples will be tested by 
Electrochemiluminescence 
Assay (ECLA) to evaluate 
presence of anti-drug 
antibodies (ADA) collected 
for all cohorts. 
o ADA samples will be 
tested at pre-dose, and 
Day 15, 30, 45, 60, 90, 
120, 150, 180, 360, and 
540 for all cohorts 
Page 55 Section 3.2.2 Secondary 
Endpoints 
• 
The assessment of Cmax, Tmax 
and AUC(0-t) for total 
monoclonal antibodies of 
ADM03820 as measured by 
enzyme-linked 
immunosorbent assay 
(ELISA) methods designed 
for total monoclonal 
antibody in the Drug 
Product. 
o Pharmacokinetic samples 
will be tested by ELISA 
at pre-dose, 2, 4, 8, and 
24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 
45, 60, 90, 120, 150, 180, 
and 365 for all cohorts 
o Samples will be tested by 
Microneutralization at 
pre-dose and Days 2, 15, 
30, 60, 90, 120, 150, and 
180 for all cohorts 
• 
Samples will be tested by 
Electrochemiluminescence 
Assay (ECLA) to evaluate 
presence of anti-drug 
antibodies (ADA) collected 
for all cohorts. 
o ADA samples will be 
tested at pre-dose, and 
Day 15, 30, 45, 60, 90, 
120, 150, 180, 365 for all 
cohorts 
• 
Incidence of the first case of 
SARS-SoV-2 RT-PCR 
positive symptomatic illness 
occurring after dosing 
through Day 365 
• 
Incidence of SARS-CoV-2 
RT-PCR positive severe or 
critical symptomatic illness 
occurring after dosing 
through Day 365 
• 
Incidence of COVID-19 
related Emergency 
Revised timepoints that samples 
will be tested based on reducing 
the subject follow-up from 18-
months to 12-months and added 
three secondary endpoints 


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Department visits occurring 
after dosing through Day 
365 
Page 40 Section 4 Study Design 
This is a Phase 1, randomized, 
double-blind, placebo-controlled 
study of four dose cohorts to 
evaluate the safety, tolerability, 
and immunogenicity of 
ADM03820 in healthy adults. 
 
The study will randomize a total 
of 40 healthy subjects to receive 
either an intramuscular (IM) 
injection or intravenous (IV) 
infusion of either ADM03820 or 
placebo.   
Page 56 Section 4 Study Design 
This is a Phase 1, randomized, 
double-blind, placebo-controlled 
study of three dose cohorts to 
evaluate the safety, tolerability, 
and immunogenicity of 
ADM03820 in healthy adults. 
The study will randomize a total 
of 185 healthy subjects to 
receive an intramuscular (IM) 
injection of either ADM03820 
or placebo.   
Revised number of cohorts from 
four to three. 
Revised number of total subjects 
from 40 to 185 
Removed reference to IV 
cohorts 
Page 40 Section 4 Study Design 
Schedule for Subjects 
 
A blinded interim safety and PK 
analysis is planned for this study 
to analyze all PK and MN 
sample through Day 30.  This 
will include all subjects in all 
cohorts through Day 30.     
 
Page 56 Section 4 Study Design 
Schedule for Subjects 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK and MN samples through 
Day 8 for all subjects in Cohorts 
1 – 3.  A second blinded interim 
analysis is planned to analyze all 
PK and MN samples after the 
first 100 subjects complete Day 
30.  A third blinded interim 
analysis is planned to analyze all 
PK and MN samples after all 
subjects in all cohorts complete 
Day 30. 
There is also an interim clinical 
study report (CSR) planned after 
all subjects complete Day 90. 
Added additional interim 
analysis 


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Page 40 Section 4 Study Design 
Schedule for Cohorts 
 
Page 56 Section 4 Study Design 
Schedule for Cohorts 
Cohort 1 (150 mg IM injection) 
will be dosed first. Two sentinel 
subjects (one ADM03820 and 
one placebo) will each be 
administered a single 3 mL IM 
injection. The dosing of the next 
subjects within Cohort 1 will not 
be initiated until at least 48 
hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.   
 
Dose escalation to Cohort 2 will 
not occur until safety data 
through day 8 for Cohort 1 is 
reviewed by the SRC.  Objective 
dose escalation criteria and 
safety evaluations will be 
utilized.   
 
In Cohort 2 (300 mg IM 
injection), two sentinel subjects 
(one ADM03820 and one 
placebo) will each be 
administered two 3 mL IM 
injections.  Dosing for the 
remaining subjects in Cohort 2 
will be initiated after at least 48 
hours have passed and no 
adverse events have occurred 
that meet halting criteria and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.   
Added language to explain IM 
dosing for each cohort.  
Removed IV Dosing 


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Dosing for Cohort 3 (300 mg IM 
injection) will not occur until 
safety data through day 8 for 
Cohort 2 is reviewed by the 
SRC.  Objective safety 
evaluations will be utilized.  
Subjects in Cohort 3 will be 
scheduled based on the SRC 
recommendation and will each 
be administered two 3 mL IM 
injections without delay. 
Page 41 Section 5 Study 
Enrollment and Withdrawal 
This study will enroll forty 
healthy male and female 
subjects ages 18 to 55 years old 
in four cohorts.   
Alternates who meet all 
eligibility criteria for IM dosing 
cohorts may effectively have 
their check-in at the same time 
as the lead two subjects and be 
rolled over into the next group 
within that cohort but will not be 
dosed until 48 hours after the 
initial two subjects are dosed.   
Alternates who meet all 
eligibility criteria for IV dosing 
cohorts may effectively have 
their check-in at the same time 
as the lead two subjects and be 
rolled over into the next group 
within that cohort but will not be 
dosed until 24 hours after the 
initial two subjects are dosed. 
Alternates not enrolled into a 
dosing group within a cohort are 
eligible for enrollment into the 
next group for that cohort. 
Page 57 Section 5 Study 
Enrollment and Withdrawal 
This study will enroll one 
hundred and eight-five healthy 
male and female subjects ages 
18 to 55 years old in three 
cohorts.   
 
Alternates who meet all 
eligibility criteria may 
effectively have their check-in at 
the same time as the lead two 
subjects and be rolled over into 
the next group within that cohort 
but will not be dosed until 
dosing for that cohort begins.   
Alternates not enrolled into the 
cohort are eligible for 
enrollment in subsequent 
cohorts but would have to 
undergo re-screening if more 
than 14 days have passed since 
their initial screening visit. 
 
Revised number of subjects 
from 40 to 185 
Clarified language for alternate 
subjects 
Page 43 Section 5.2 Exclusion 
Criteria 
11. Donated blood within 56 
days of enrollment. 
Page 59 Section 5.2 Exclusion 
Criteria 
11. Donated blood or plasma 
within 56 days of enrollment. 
Added or plasma 


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Page 43 Section 5.2 Exclusion 
Criteria 
 
 
Page 60 Section 5.2 Exclusion 
Criteria 
24. Received an approved 
COVID-19 vaccine (subjects 
can receive an approved 
COVID-19 vaccine after 
completing their Day 90 visit. 
Added exclusion for receiving 
the COVID-19 vaccine 


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Page 44 Section 5.3 Treatment 
Assignment Procedures 
For each dosing cohort the first 
two subjects will be randomized 
in a 1:1 fashion to active and 
placebo to ensure that one of the 
first two subjects receives active 
treatment and the other 
control.  An alternate subject 
will be admitted to the unit for 
each two-subject group.  If one 
of the first two subjects is not 
randomized for any reason, then 
the alternate subject will receive 
the next consecutive 
randomization number. The 
product assignment of the 
remaining subjects in each 
cohort will follow a 7:1 
randomization of active to 
placebo, respectively.  The 
randomization list will be 
generated by the unblinded 
study biostatistician and 
transferred to the unblinded 
study pharmacist prior to start of 
the study.   
 
Page 60 Section 5.3 Treatment 
Assignment Procedures 
For cohorts 1 and 2 the first two 
subjects will be randomized in a 
1:1 fashion to active and placebo 
to ensure that one of the first 
two subjects receives active 
treatment and the other 
control.  An alternate subject 
will be admitted to the unit for 
each two-subject group.  If one 
of the first two subjects is not 
randomized for any reason, then 
the alternate subject will receive 
the next consecutive 
randomization number. The 
product assignment of the 
remaining subjects in each 
cohort will follow a 7:1 
randomization of active to 
placebo, respectively.  The 
randomization list will be 
generated by the unblinded 
study biostatistician and 
uploaded to IRT system by 
vendor (4G Clinical). Upon 
confirming eligibility of 
subjects, site research personnel 
will randomize subjects then the 
unblinded study pharmacist will 
be notified of treatment 
allocation via system-generated 
email. 
Subjects in cohort 3 will be 
randomized in a 2:1 ratio of 
active to placebo.  The 
randomization list will be 
generated by the unblinded 
study biostatistician and 
uploaded to IRT system by 
vendor (4G Clinical). Upon 
confirming eligibility of 
subjects, site research personnel 
will randomize subjects then the 
unblinded study pharmacist will 
be notified of treatment 
Clarified language for 
randomization within each 
cohort 


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allocation via system-generated 
email.   
Page 46 Section 5.3.4 Handling 
of Withdrawals 
Subjects who are withdrawn 
prior to dosing must be replaced.  
Following dosing one subject 
per cohort may withdraw prior 
to the completion of Visit 11 
(day 60) or was noncompliant 
with all PK draws through Visit 
6 (day 4) without being 
replaced.   
Page 62 Section 5.3.4 Handling 
of Withdrawals 
Subjects who are withdrawn 
prior to dosing must be replaced.  
Following dosing in cohorts 1 
and 2, one subject per cohort 
may withdraw prior to the 
completion of Visit 11 (day 60) 
or was noncompliant with all PK 
draws through Visit 6 (day 4) 
without being replaced.   
If 4 or more subjects withdraw, 
are lost to follow up or terminate 
prior to Day 8 within a cohort, at 
least one of those subjects need 
to be replaced to ensure that data 
for at least 7 subjects are 
available for review. 
If 4 or more subjects withdraw, 
are lost to follow up or terminate 
on or after Day 8 but prior to 
Day 60 or are not compliant 
with all PK draws through Day 
15 within a cohort, they should 
be replaced.   
If more than 4 subjects 
withdraw, are lost to follow up 
or terminate following the Day 8 
SRC review of safety data 
within a cohort, the site will 
attempt to replace those subjects 
in that dose group at the time of 
the next planned cohort. 
All replaced subjects will be 
assigned to the same treatment 
assignment as the subject they 
are replacing. This will be 
documented in the source 
documents and eCRFs. 
Subjects that withdraw from 
cohort 3 after dosing will not be 
replaced. 
Added language to clarify 
replacement of subjects that 
withdraw from the study. 


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Page 47 Section 6.3 
Formulation, Packaging, and 
Labeling 
ADM03820 will be 
administered by intramuscular 
(IM) injection  or intravenous 
(IV) infusion as follows: 150 mg 
(1 x 3 mL IM injection) or 300 
mg (2 x 3 mL IM injections), 
10mg/kg (~15 mL IV infusion), 
and 20 mg/kg (~30 mL IV 
infusion). 
Page 63 Section 6.3 
Formulation, Packaging, and 
Labeling 
ADM03820 will be 
administered by intramuscular 
(IM) injection as follows: 150 
mg (1 x 3 mL IM injection) or 
300 mg (2 x 3 mL IM 
injections). 
Removed IV infusion 
Page 48 Section 6.5 Dosage, 
Preparation, and Administration 
Administration of the IV dose of 
ADM03820 or placebo must be 
started within 30 minutes of 
preparation.  
Page 64 Section 6.5 Dosage, 
Preparation, and Administration 
 
Removed IV dosing preparation 
 
Page 50 Section 7.3 Vital Signs 
During screening and follow-up, 
a measurement that is Grade 1 
(as referenced in Appendix B 
Toxicity Grading ) may be 
repeated once if the PI believes 
a transient condition led to the 
aberrant value. 
Page 66 Section 7.3 Vital Signs 
During screening and follow-up, 
a measurement that is Grade 1 
(as referenced in Appendix B 
CTCAE version 5.0) may be 
repeated once if the PI believes 
a transient condition led to the 
aberrant value. 
Changed toxicity grading to use 
CTCAE version 5.0 
Page 51 Section 7.5.1.4 
Screening Laboratory Tests 
Page 68 Section 7.5.1.4 
Screening Laboratory Tests 
o FSH to confirm post-
menopausal status for 
women ≥ 1 year without 
menses 
Added FSH test 
Page 54 Table 2 Laboratory 
Samples and Estimated Total 
Blood Volume 
Page 70 Table 2 Laboratory 
Samples and Estimated Total 
Blood Volume 
Revised table for reducing 
subject participation from 18-
months to 12-months 
Page 55 Section 8 Study 
Schedule 
Page 71 Section 8 Study 
Schedule 
Revised visit schedule for 
reducing the subject 
participation from 18-months to 
12-months 
Page 56 Section 8.2 Visit 2: 
Baseline / Admission to Unit 
(Day -1) 
Page 72 Section 8.2 Visit 2: 
Baseline / Day of Dosing 
Revised to remove the Day -1 
visit and make baseline visit the 
day of dosing 
Removed reference to IV dosing 
Page 71 Section 9.5.1 Halting 
Criteria for Infusion Dosing 
Page 85 Section 9.5.1 Halting 
Criteria for Infusion Dosing 
Removed IV dosing halting 
criteria 


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Page 74Section 11.1 Sample 
Size Considerations  
Dosing groups of ten 
participants each, eight 
participants assigned the active 
group and two assigned to the 
control group practical and 
provide sufficient information 
for a total sample size of 40 for 
a Phase 1 trial primarily 
designed to assess safety. 
Page 87 Section 11.1 Sample 
Size Considerations  
Dosing groups of ten 
participants each, eight 
participants assigned the active 
group and two assigned to the 
control group for cohorts 1 and 
2, and a dosing group of one 
hundred sixty-five participants 
in cohort 3, one hundred ten 
participants assigned to the 
active group and fifty-five 
assigned to the control group are 
practical and provide sufficient 
information for a total sample 
size of 185 for a Phase 1 trial 
primarily designed to assess 
safety. 
Revised to reflect three cohorts 
and 185 subjects 
Page 74 Section 11.2 Planned 
Interim Analysis 
A blinded interim safety and PK 
analysis is planned for this study 
to analyze all PK and MN 
samples through Day 30.  This 
will include all subjects in all 
cohorts.   
Page 87 Section 11.2 Planned 
Interim Analysis 
There are several blinded 
interim analyses planned for this 
study.  A blinded interim 
analysis is planned to analyze all 
PK and MN samples through 
Day 8 for all subjects in Cohorts 
1 – 3.  A second blinded interim 
analysis is planned to analyze all 
PK and MN samples after all 
subjects in all cohorts complete 
Day 30. 
 
There is also an interim clinical 
study report (CSR) planned after 
all subjects complete Day 90. 
Added interim analysis and 
interim CSR 
Page 84 Appendix A Schedule 
of Events 
Page 97 Appendix A Schedule 
of Events 
Revised to reduce subject 
participation from 18-months to 
12-months 
Page 86 Appendix B Toxicity 
Grading 
Page 99 Appendix B CTCAE 
v5.0 
Revised to use CTCAE v5.0 
 
 


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Page 13 Protocol 
Summary/Study Duration – 
Approximately 10 months 
 
Page 25 Protocol Summary 
Study Duration – Approximately 
18 months 
 
Extended the length of subject 
follow-up to 18-months 
Page 13 Protocol 
Summary/Subject Participation 
Duration 
Subjects in all cohorts will 
participate approximately 208 
days (up to a 14-day screening, 
overnight stay, up to 180 days 
outpatient follow-up) 
Page 25 Protocol 
Summary/Subject Participation 
Duration 
Subjects in all cohorts will 
participate approximately 554 
days (up to a 14-day screening, 
overnight stay, up to 18-month 
outpatient follow-up) 
Extended the length of subject 
follow-up to 18-months 
Page 13 Protocol 
Summary/Secondary Endpoints 
Pharmacokinetic samples will be 
tested by ELISA at pre-dose, 2, 
4, 8, and 24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150 and 180, for all 
cohorts 
 
Page 25 Protocol 
Summary/Secondary Endpoints 
Pharmacokinetic samples will be 
tested by ELISA at pre-dose, 2, 
4, 8, and 24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, 360, and 540 
for all cohorts 
 
Extended the length of subject 
follow-up to 18-months 
Page 14 Protocol 
Summary/Secondary Endpoints 
ADA samples will be tested at 
pre-dose, and Day 15, 30, 45, 
60, 90, 120, 150, and 180 for all 
cohorts 
Page 26 Protocol 
Summary/Secondary Endpoints 
ADA samples will be tested at 
pre-dose, and Day 15, 30, 45, 
60, 90, 120, 150, 180, 360, and 
540 for all cohorts 
Extended the length of subject 
follow-up to 18-months 


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Page 14 Protocol Summary/ 
Study Design 
The dosing of the next subjects 
within Cohort 1 will not be 
initiated until at least 24 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed as 
scheduled without delay. 
Page 26 Protocol Summary/ 
Study Design 
The dosing of the next subjects 
within Cohort 1 will not be 
initiated until at least 48 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.   
Added a longer delay of 
subsequent enrollment (48 
hours) following sentinel cohort 
in subjects receiving the IM 
dose. 
Page 14 Protocol Summary/ 
Study Design 
The dosing of the next subjects 
within Cohort 2 will not be 
initiated until at least 24 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed as 
scheduled without delay. 
 
Page 26 Protocol Summary/ 
Study Design 
The dosing of the next subjects 
within Cohort 2 will not be 
initiated until at least 48 hours 
have passed and no adverse 
events have occurred that meet 
halting criteria and no safety 
signals have occurred that in the 
opinion of the investigator 
warrant further investigation.  
The remaining subjects in the 
cohort will be dosed at least four 
hours apart until all subjects in 
the cohort have been dosed.   
Added a longer delay of 
subsequent enrollment (48 
hours) following sentinel cohort 
in subjects receiving the IM 
dose. 
Page 15 Protocol 
Summary/Study Design 
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, and 180.   
Page 27 Protocol 
Summary/Study Design 
Follow-up visits will occur on 
Days 2, 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, 360, and 540 
with telephone visits at Days 
270 and 450.   
Extended the length of subject 
follow-up to 18-months 


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Page 17 Protocol 
Summary/Exclusion Criteria 
20. Use of any prohibited 
medication within 28 days prior 
to screening  or planned use 
during the study period 
• 
Note: Prohibited 
medications include 
immunosuppressives (except 
Nonsteroidal Anti-
Inflammatory Drugs 
[NSAIDS]); immune 
modulators; oral 
corticosteroids 
(topical/intranasal steroids 
are acceptable); anti-
neoplastic agents; any 
vaccine (licenses or 
investigational) 
 
Page 29 Protocol 
Summary/Exclusion Criteria 
20. Use of any prohibited 
medication within 28 days prior 
to screening  or planned use 
during the study period 
• 
Note: Prohibited 
medications include 
immunosuppressives (except 
Nonsteroidal Anti-
Inflammatory Drugs 
[NSAIDS]); immune 
modulators; oral 
corticosteroids 
(topical/intranasal steroids 
are acceptable); anti-
neoplastic agents 
 
Removed vaccine exclusion to 
allow subject to receive 
necessary vaccinations  
Page 26 Section 2.3.1 Potential 
Risks/IM Injection 
An IM injection may cause 
some discomfort at the injection 
site.  Other risks may include 
pain, redness, swelling, or 
warmth at the injection 
Page 38 Potential Risks/IM 
Injection 
An IM injection may cause 
some discomfort at the injection 
site.  Other risks may include 
pain, redness, swelling, or 
warmth at the injection site.  
These risks are minimal. 
An IM injection into the gluteus 
medius may cause sciatic nerve 
damage, bleeding, hematoma, or 
infection.  
 
Revised location of the IM dose 
to the gluteus medius 


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Page 27 Section 3.2.2 Study 
Outcome Measures/Secondary 
Endpoints 
Pharmacokinetic samples will be 
tested by ELISA at pre-dose, 2, 
4, 8, and 24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150 and 180, for all 
cohorts 
 
Page 39 Study Outcome 
Measures/Secondary Endpoints 
Pharmacokinetic samples will be 
tested by ELISA at pre-dose, 2, 
4, 8, and 24 hours post dose, and 
on Days 3, 4, 8, 15, 30, 45, 60, 
90, 120, 150, 180, 360, and 540 
for all cohorts 
 
Extended the length of subject 
follow-up to 18-months 
Page 27 Section 3.2.2 Study 
Outcome Measures/Secondary 
Endpoints 
ADA samples will be tested at 
pre-dose, and Day 15, 30, 45, 
60, 90, 120, 150, and 180 for all 
cohorts 
Page 40 Study Outcome 
Measures/Secondary Endpoints 
ADA samples will be tested at 
pre-dose, and Day 15, 30, 45, 
60, 90, 120, 150, 180, 360, and 
540 for all cohorts 
Extended the length of subject 
follow-up to 18-months 
Page 28 Section 4 Study 
Design/Schedule for Subjects 
Subjects in all cohorts will 
participate in the study for 
approximately 180 days, 
including a 14-day screening 
period.  All subjects in the study 
will have a 24-hour stay in the 
clinic after dosing is complete to 
ensure that no hypersensitivities 
or safety signals occur.  Follow-
up visits will occur on Days 3, 4, 
8, 15, 30, 45, 60, 90,120, 150 
and 180.  The last follow up 
visit is scheduled at Day 180.   
Page 40 Study Design/Schedule 
for Subjects 
Subjects in all cohorts will 
participate in the study for 
approximately 554 days, 
including a 14-day screening 
period.  All subjects in the study 
will have a 24-hour stay in the 
clinic after dosing is complete to 
ensure that no hypersensitivities 
or safety signals occur.  Follow-
up visits will occur on Days 3, 4, 
8, 15, 30, 45, 60, 90,120, 150, 
180, 360, and 540 with 
telephone visits at Days 270 and 
450.  The last follow up visit is 
scheduled at Day 540.   
Extended the length of subject 
follow-up to 18-months 
 
 
 
 
 
 


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Page 28 Section 4 Study 
Design/Schedule for Cohorts 
The dosing of the remaining 
subjects within that cohort will 
not be initiated until at least 24 
hours have passed and no 
adverse events have occurred 
that meet halting criteria, and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.   
The remaining subjects in the 
cohort  will be dosed without 
delay.   
Page 41 Study Design/Schedule 
for Cohorts 
The IM dosing of the remaining 
subjects within cohorts 1 and 2 
will not be initiated until at least 
48 hours have passed and no 
adverse events have occurred 
that meet halting criteria, and no 
safety signals have occurred that 
in the opinion of the investigator 
warrant further investigation.   
The remaining subjects in 
cohorts 1 and 2 will be dosed at 
least four hours apart until all 
subjects in the cohort have been 
dosed.     The IV dosing of the 
remaining subjects in cohort 3 
and 4 will not be initiated until 
at least 24  hours have passed 
and no adverse events have 
occurred that meet halting 
criteria, and no safety signals 
have occurred in the opinion of 
the investigator warrant further 
investigation.  The remaining 
subjects in cohorts 3 and 4 will 
be dosed as scheduled without 
delay.   
Added a longer delay of 
subsequent enrollment (48 
hours) following sentinel cohort 
in subjects receiving the IM 
dose. 


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Page 29 Section 5 Study 
Enrollment and Withdrawal 
Alternates who meet all 
eligibility criteria may 
effectively have their check-in at 
the same time as the lead two 
subjects and be rolled over into 
the next group within that cohort 
but will not be dosed until 24 
hours after the initial two 
subjects are dosed.    
Page 41 Study Enrollment and 
Withdrawal 
Alternates who meet all 
eligibility criteria for IM dosing 
cohorts may effectively have 
their check-in at the same time 
as the lead two subjects and be 
rolled over into the next group 
within that cohort but will not be 
dosed until 48 hours after the 
initial two subjects are dosed.   
Alternates who meet all 
eligibility criteria for IV dosing 
cohorts may effectively have 
their check-in at the same time 
as the lead two subjects and be 
rolled over into the next group 
within that cohort but will not be 
dosed until 24 hours after the 
initial two subjects are dosed. 
Added a longer delay of 
subsequent enrollment (48 
hours) following sentinel cohort 
in subjects receiving the IM 
dose. 
Page 31 Section 5.2 Subject 
Exclusion Criteria 
20. Use of any prohibited 
medication within 28 days prior 
to screening or planned use 
during the study period 
• 
Note: Prohibited 
medications include 
immunosuppressives (except 
Nonsteroidal Anti-
Inflammatory Drugs 
[NSAIDS]); immune 
modulators; oral 
corticosteroids 
(topical/intranasal steroids 
are acceptable); anti-
neoplastic agents; any 
vaccine (licenses or 
investigational) 
Page 44 Section 5.2 Subject 
Exclusion Criteria 
20. Use of any prohibited 
medication within 28 days prior 
to screening or planned use 
during the study period 
Note: Prohibited medications 
include immunosuppressives 
(except Nonsteroidal Anti-
Inflammatory Drugs 
[NSAIDS]); immune 
modulators; oral corticosteroids 
(topical/intranasal steroids are 
acceptable); anti-neoplastic 
agents 
Removed vaccine exclusion to 
allow subject to receive 
necessary vaccinations 


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Page 36 Section 6.5 Dosage, 
Preparation and Administration 
Administration of the IM dose 
of ADM03820 or placebo 
should be injected into the 
gluteus maximus and must be 
completed within 30 minutes of 
preparation.    
Page 48 Section 6.5 Dosage, 
Preparation and Administration 
Administration of the IM dose 
of ADM03820 or placebo 
should be injected into the 
gluteus medius (see Appendix 
C) and must be completed 
within 30 minutes of 
preparation.    
Revised location of IM dose to 
the gluteus medius 
Page 37 Section 6.8 
Concomitant Medications 
Subjects will be instructed to 
refrain from the receipt of any of 
the following during study 
participation unless medically 
indicated and deemed 
immediately necessary by their 
private physician: 
• Blood or blood products, 
• Any antibody (e.g. TIG, 
VZIG, IVIG, IM gamma 
globulin) 
• Any vaccine (licensed or 
investigational) 
• Monoclonal antibody 
• H1 antihistamines 
• Beta-blockers 
• Immunosuppressives (except 
NSAIDS) 
• Oral corticosteroids 
(topical/intranasal steroids 
are acceptable) 
• Anti-neoplastic agents 
 
Page 49 Section 6.8 
Concomitant Medications 
Subjects will be instructed to 
refrain from the receipt of any of 
the following during study 
participation unless medically 
indicated and deemed 
immediately necessary by their 
private physician: 
• Blood or blood products, 
• Any antibody (e.g. TIG, 
VZIG, IVIG, IM gamma 
globulin) 
• Monoclonal antibody 
• H1 antihistamines 
• Beta-blockers 
• Immunosuppressives (except 
NSAIDS) 
• Oral corticosteroids 
(topical/intranasal steroids 
are acceptable) 
• Anti-neoplastic agents 
 
Removed vaccinations as an 
excluded medication to allow 
subject to receive necessary 
vaccinations 


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Page 37 Section 7.1 Medical 
History and COVID-19 
Instruction 
Page 50 Section 7.1 Medical 
History and COVID-19 
Instruction 
 If a subject acquires COVID-19 
during their participation in the 
study, they should seek and 
obtain the appropriate treatment.   
Added language to ensure that 
subjects are permitted to seek 
and obtain treatment of COVID-
19, if acquired 
Page 39 Section 7.5.1.3 
Pregnancy Testing 
A urine pregnancy test will be 
repeated on Day 4, Day 45, Day 
120, 150, and Day 180 (end of 
study). 
Page 51 Section 7.5.1.3 
Pregnancy Testing 
A urine pregnancy test will be 
repeated on Day 4, Day 45, Day 
120, 150, Day 180, 360, and 540 
(end of study). 
Extended the length of subject 
follow-up to 18-months 
Page 39 Section 7.5.2 Safety 
Laboratory Tests 
The following laboratory tests 
will be performed at Days 8, 15, 
30, 90, and end of study.   
Page 52 Section 7.5.2 Safety 
Laboratory Tests 
The following laboratory tests 
will be performed at Days 8, 15, 
30, 90, and 180, 360 and end of 
study.   
Extended the length of subject 
follow-up to 18-months 
Page 40 Section 7.6.1 
Pharmacokinetic Assay 
PK samples will be tested by 
ELISA at pre-dose, 2, 4, 8, and 
24 hours post dose and on Days 
3, 4, 8, 15, 30, 45, 60, 90, 120, 
150 and 180. 
Page 52 Section 7.6.1 
Pharmacokinetic Assay 
PK samples will be tested by 
ELISA at pre-dose, 2, 4, 8, and 
24 hours post dose and on Days 
3, 4, 8, 15, 30, 45, 60, 90, 120, 
150, 180, 360, and 540. 
Extended the length of subject 
follow-up to 18-months 
Page 40 Section 7.6.3 
Immunogenicity / Anti-Drug 
Antibody Assay 
Six-mL samples of blood will be 
drawn at pre-dose and on Days 
15, 30,45,60, 90, 120, 150, and 
180 
Page 53 Section 7.6.3 
Immunogenicity / Anti-Drug 
Antibody Assay 
Six-mL samples of blood will be 
drawn at pre-dose and on Days 
15, 30,45,60, 90, 120, 150, 180, 
360, and 540 
Extended the length of subject 
follow-up to 18-months 


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Page 41 Section 7.6.4  RT-PCR 
Testing for SARS-CoV-2 
 
Page 53 Section 7.6.4 RT-PCR 
Testing for SARS-CoV-2 
If a subject acquires COVID-19 
during their participation in the 
study, they should seek and 
obtain the appropriate treatment.   
Added language 
Page 42 Table 2 Laboratory 
Samples and Estimated Total 
Blood Volume (mL) 
Page 54 Table 2 Laboratory 
Samples and Estimated Total 
Blood Volume (mL) 
Updated table to include 
additional blood volumes for 
additional visits 
Page 45 Section 8.3 Visit 3: Day 
of Dosing (Day 1) 
IM Cohorts-During Dosing 
Study product should be injected 
into the gluteus maximus.   
Page 57 Section 8.3 Visit 3: Day 
of Dosing (Day 1) 
IM Cohorts-During Dosing 
Study product should be injected 
into the gluteus medius (see 
Appendix C).   
Revised location of IM dosing to 
the gluteus medius 
Page 47 Section 8.4 Visit 4: 
Discharge from Unit (Day 2) 
Remind the subject not to 
receive any routine vaccines or 
drugs listed in section 6.8 for the 
duration of the study unless 
clinically indicated.   If subjects 
receive vaccines that are 
clinically indicated (e.g. tetanus 
after an open wound injury), 
they will be instructed to contact 
study staff immediately.  If 
study activities overlap with 
influenza season, subjects will 
be instructed to delay influenza 
vaccination until after Day 60 
(Visit 11). 
Page 60 Section 8.4 Visit 4: 
Discharge from Unit (Day 2) 
Remind the subject not to 
receive any drugs listed in 
section 6.8 for the duration of 
the study unless clinically 
indicated.   If subjects receive 
necessary vaccines that are 
clinically indicated (e.g. tetanus 
after an open wound injury, 
influenza), they will be 
instructed to contact study staff 
immediately.  
 
Removed vaccinations as an 
excluded medication to allow 
subject to receive necessary 
vaccinations 
Page 52 Section 8.15 Visit 15: 
Final Visit / Early Termination 
Visit (day 180±3) 
Page 64 Section 8.15 Visit 15: 
Out-Patient Follow-Up Visit 
(day 180±3) 
Day 180 is no longer the end of 
study 
N/A 
Page 64 Section 8.16 Visit 16: 
Telephone Visit (Day 270±3) 
Added visits to extend length of 
subject follow up 


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N/A 
Page 64 Section 8.17 Visit 17: 
Out-Patient Follow-Up (Day 
360±3) 
Added visits to extend length of 
subject follow up 
N/A 
Page 65 Section 8.18 Visit 18: 
Telephone Visit (Day 450±3) 
Added visits to extend length of 
subject follow up 
N/A 
Page 65 Section 8.19 Visit 19: 
Final Visit / Early Termination 
(Day 540±3) 
Added visit to extend length of 
subject follow up 
Page 52 Section 8.16 
Unscheduled Visit 
Page 66 Section 8.20 
Unscheduled Visit 
Added visits to extend length of 
subject follow up 
Page 53 Section 9 Assessment 
of Safety 
Page 66 Section 9 Assessment 
of Safety 
have emergency staff and 
medications such as 
epinephrine, corticosteroids, 
bronchodilators, and emergency 
tool kits for emergent intubation 
and initial acute 
cardiopulmonary resuscitative 
care are available at all clinical 
sites in the event they are 
needed during and immediately 
after IM injections or IV 
infusions. 
Additional safety language 
added 
Page 57 Section 9.4 Type and 
Duration of Follow-up of 
Subjects after Adverse Events 
Subjects who experience AEs 
consistent with COVID-19 
through Day 180 will be 
evaluated either by the site or by 
a health care provider to which 
the subject may be referred. 
Page 70 Section 9.4 Type and 
Duration of Follow-up of 
Subjects after Adverse Events 
Subjects who experience AEs 
consistent with COVID-19 
through Day 540 will be 
evaluated either by the site or by 
a health care provider to which 
the subject may be referred. 
Extended the length of subject 
follow-up to 18-months 


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Page 57 Section 9.5.1 Halting 
Criteria for the Study 
Page 71 Section 9.5.1 Halting 
Criteria for Infusion Dosing 
Study dosing can be halted at 
any time if medically indicated.   
Intravenous infusion dosing 
should be immediately stopped 
should any of the following 
occur: 
• 
Profound hypotension 
(systolic blood pressure < 85 
mmHg) 
• 
Tachycardia with an 
increase in resting heart rate 
to > 130 beats per minute 
(bpm); or development of a 
ventricular dysrhythmia; or 
bradycardia <45 bpm (or 
<40 bpm in subjects with a 
baseline of <60bpm) that is 
associated with complaints 
of dizziness, nausea or 
feeling faint 
• 
Shortness of breath, 
wheezing, or sustained (i.e. 
≥10 seconds) oxygen 
saturation < 92% on room 
air 
• 
Severe (Grade ≥3) local 
infusion site reactions, 
including pain, tenderness, 
erythema, or swelling as 
defined in the toxicity 
grading scale (Appendix B) 
• 
Body core temperature 
exceeding 1.5°C above 
baseline 
• 
Suspected sepsis 
• 
Severe chest pain 
Added language for halting 
criteria for IV dosing 


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Reason for Change 
• 
Suspected anaphylaxis  
 
Page 70 Appendix A: Schedule 
of Events 
 
Page 84 Appendix A: Schedule 
of Events 
Added visits to extend length of 
subject follow up 
N/A 
Page 89 Appendix C: 
Intramuscular (IM) 
Administration  
Added appendix for IM 
injection instructions  
 
 


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PROTOCOL SUMMARY 
Protocol 
Element 
Description 
Study Title 
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation 
Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of 
ADM03820 in Adults. 
Clinical Phase 
Phase 1 
Study 
Population  
A total of 50 healthy male and female subjects between 18 – 55 years of age 
Number of 
Sites 
Approximately 5 
Study Duration  Approximately 18 months for cohorts 1-4 and 12 months for cohort 5 
Subject 
Participation 
Duration 
Subjects in cohorts 1-4 will participate approximately 554 days (up to a 14-
day screening, overnight stay, up to 12-month outpatient follow-up visits and 
telephone visits at 15-months and 18-months.) 
 
Subjects in cohort 5 will participate approximately 379 days (up to a 14-day 
screening, overnight stay, and up to 12-month outpatient follow-up visits.) 
Description of 
Study Product 
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding 
anti-SARS-CoV-2 antibodies, mAb2130 (YTE+LALA) and mAb2381 
(YTE+LALA), individually expressed in a Chinese hamster ovary (CHO) 
cell line. 
Route of 
Delivery 
Subjects will receive IM injections in the buttocks  
Study 
Objectives 
Primary Objective 
• To assess the safety and tolerability of different doses of ADM03820 in 
healthy adult subjects 
 
Secondary Objective 
• To assess the pharmacokinetics (PK) and immunogenicity (ADA) of 
different doses of ADM03820 in healthy adult subjects 
 
Study 
Endpoints 
Primary Endpoints 
• The occurrence of Serious Adverse Events following administration of 
ADM03820 to the final visit 
• The occurrence of AEs from administration of ADM03820 to the final 
visit 
• The occurrence of changes from baseline in physical examination, vital 
signs, and clinical safety laboratory values following administration of 
ADM03820 to the final follow up visit 
 
Secondary Endpoints 


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• The assessment of Cmax, Tmax and AUC(0-t) for total antibodies of 
ADM03820 as measured by enzyme-linked immunosorbent assay 
(ELISA) for samples from Cohorts 1 and 2. The assessment of Cmax, Tmax 
and AUC(0-t) for each of the monoclonal antibodies  of ADM03820 as 
measured by enzyme-linked immunosorbent assay (ELISA) for samples 
from Cohort 3, Cohort 4, and Cohort 5. 
o Pharmacokinetic samples will be tested by ELISA at pre-dose, 2, 4, 
8, and 24 hours post dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 
120, 150, 180, and 365 for all cohorts 
o Samples will be tested by Microneutralization at pre-dose and Days 
2, 15, 30, 60, 90, 120, 150, and 180 for all cohorts 
 
• Samples will be tested by Electrochemiluminescence Assay (ECLA)  to 
evaluate presence of anti-drug antibodies (ADA) collected for all cohorts. 
o ADA samples will be tested at pre-dose, and Day 15, 30, 45, 60, 90, 
120, 150, 180, and 365 for all cohorts 
 
• Incidence of the first case of SARS-CoV-2 RT-PCR positive 
symptomatic illness occurring after dosing through Day 365 
 
• Incidence of SARS-CoV-2 RT-PCR positive severe or critical 
symptomatic illness occurring after dosing through Day 365 
 
• Incidence of COVID-19 related Emergency Department visits occurring 
after dosing through Day 365 
 
Study Design  
This study is a phase 1, randomized, double-blind, placebo-controlled study 
of five dose cohorts.  The study will randomize a total of 50 healthy subjects 
to receive an intramuscular (IM) injection of either ADM03820 or placebo.   
 
Dosing Cohorts: 
• Cohort 1 –150 mg IM injection (8 active, 2 placebo) 
• Cohort 2 – 300 mg IM injection (8 active, 2 placebo) 
• Cohort 3 –300 mg IM injection (8 active, 2 placebo) 
• Cohort 4 – 300 mg IM injection (8 active, 2 placebo) 
• Cohort 5 – 600 mg IM Injection (8 active, 2 placebo) 
 
Cohort 1 (150 mg IM injection) will be dosed first. Two sentinel subjects 
(one ADM03820 and one placebo) will each be administered a single 3 mL 
IM injection. The dosing of the next subjects within Cohort 1 will not be 
initiated until at least 48 hours have passed and no adverse events have 
occurred that meet halting criteria and no safety signals have occurred that in 


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the opinion of the investigator warrant further investigation.  The remaining 
subjects in the cohort will be dosed at least four hours apart until all subjects 
in the cohort have been dosed.   
 
Dose escalation to Cohort 2 will not occur until safety data through day 8 for 
Cohort 1 is reviewed by the Safety Review Committee (SRC), which is 
composed of the Principal Investigator (PI), Resilience Government Services 
(RGS) Medical Lead (ML), and ICON Medical Monitor.  Objective dose 
escalation criteria and safety evaluations will be utilized.   
 
In Cohort 2 (300 mg IM injection), two sentinel subjects (one ADM03820 
and one placebo) will each be administered two 3 mL IM injections.  Dosing 
for the remaining subjects in Cohort 2 will be initiated after at least 48 hours 
have passed and no adverse events have occurred that meet halting criteria 
and no safety signals have occurred that in the opinion of the investigator 
warrant further investigation.  The remaining subjects in the cohort will be 
dosed at least four hours apart until all subjects in the cohort have been 
dosed.   
 
Dosing for Cohort 3 (300 mg IM injection) will not occur until safety data 
through day 8 for Cohort 2 is reviewed by the SRC.  Objective safety 
evaluations will be utilized.  Subjects in Cohort 3 will be scheduled based on 
the SRC recommendation and will each be administered two 3 mL IM 
injections without delay. 
 
Cohort  4 (300 mg IM injection) will enroll ten subjects without delay using 
100 mg/mL drug product. All subjects in the study will have a 24-hour stay 
in the clinic after dosing is complete to ensure that no hypersensitivities or 
safety signals occur.  Follow-up visits will occur on Days 2, 3, 4, 8, 15, 30, 
45, 60, 90, 120, 150, 180, and 365.  Subjects will have follow-up telephone 
visits at Days 450 and 540.  
 
Cohort 5 (600 mg IM injection) will enroll two sentinel subjects (one 
ADM03820 and one placebo) and each will be administered two 3 mL IM 
injections.  Dosing for the remaining subjects in Cohort 5 will be initiated 
after at least 48 hours have passed and no adverse events have occurred that 
meet halting criteria and no safety signals have occurred that in the opinion 
of the investigator warrant further investigation.  The remaining subjects in 
the cohort will be dosed at least four hours apart until all subjects in the 
cohort have been dosed.  Follow-up visits will occur on Days 2, 3, 4, 8, 15, 
30, 45, 60, 90, 120, 150, 180, and 365.   
 


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The study will consist of a fourteen-day screening period.  The end of the 
study is defined as the date of the last visit of the last subject in the study 
(day 540 for cohorts 1-4 and day 365 for cohort 5) 
 
There are several blinded interim analyses planned for this study.   
• A blinded interim analysis is planned to analyze all PK samples 
through Day 30 for all subjects in Cohorts 1 and 2.   
• A second blinded interim analysis is planned to analyze all PK 
samples after all subjects in Cohorts 1-3 complete Day 60. 
• A third interim analysis is planned to analyze safety and PK after all 
subjects in cohort 5 complete Day 60. 
 
There is also an interim clinical study report (CSR) planned after subjects in 
Cohorts 1 through 4 complete Day 90. 
Inclusion 
Criteria 
1. Informed consent understood and signed 
2. Healthy male or healthy, non-pregnant, non-lactating female 
3. Willingness to comply and be available for all protocol procedures for 
the duration of the study 
4. Between the ages of 18 and 55, inclusive on the day of dosing 
5. Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2 
6. Female subjects of childbearing potential must have a negative serum 
pregnancy test at screening and negative urine pregnancy test on Day 1 
prior to dosing.   
• Note: A woman is considered of childbearing potential unless post-
menopausal  (≥ 1 year without menses without other known or 
suspected cause and appropriately elevated FSH) or surgically 
sterilized via bilateral oophorectomy or hysterectomy 
7. Females of childbearing potential and males agree to use acceptable 
contraception for the duration of the study  
• Note: These include progestin implants, intrauterine devices (IUDs), 
surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. 
Use of methods such as progestin injectables, combined oral 
hormonal contraceptives, condoms, and diaphragms will not be 
acceptable when used alone, but they could be considered, if used in 
combination with another method (for example, a female using 
combined oral contraceptives if her male partner is sterile, or if she 
and her non-sterile male partner use a double-barrier method), after 
consultation with the RGS ML. All males will be required to use a 
barrier method (condoms) for the duration of the study 
8. Screening laboratory tests are within normal ranges or outside the normal 
ranges and considered not clinically significant by the Principal 
Investigator 
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microscopic evaluation will be performed and the results will supersede 
the results of the dipstick for blood, glucose, and protein. 
10. Menstruating females failing inclusion criteria due to a positive blood on 
urine test may be retested following cessation of menses.   
11. Other laboratory values that are outside the range of eligibility but are 
thought to be due to an acute condition or collection or laboratory error 
may be repeated once. 
12. The urine drug screen is negative 
13. Breathalyzer test or blood/saliva alcohol test is negative and subject 
agrees to abstain from alcohol consumption for a period of 2 days prior to 
dosing and 2 days prior to any study visit. 
14. Agree to minimize risk of SARS-CoV-2 infection. 
Exclusion 
Criteria 
1. History of chronic medical condition that would either interfere with the 
accurate assessment of the objectives of the study or increase the risk 
profile of the subject. 
2. Subjects with cardiovascular disease 
3. Subjects with diabetes 
4. Subjects with pulmonary diseases such as COPD or asthma 
5. History of severe allergic reactions of any type to medications, bee 
stings, food, or environmental factors or hypersensitivity or reaction to 
immunoglobins.  
6. A marked baseline prolongation of QT/QTc interval (e.g., repeated 
demonstration of a QTc interval >450 milliseconds) 
7. Clinically significant abnormal electrocardiogram at screening. 
• Note: Clinically significant abnormal ECG results include but not 
limited to: complete left or right bundle branch block; other 
ventricular conduction block; 2nd degree or 3rd degree 
atrioventricular (AV) block; sustained ventricular arrhythmia; 
sustained atrial arrhythmia; two Premature Ventricular Contractions 
in a row; pattern of ST elevation felt consistent with cardiac 
ischemia; or any condition deemed clinically significant by a study 
investigator 
• Incomplete right bundle branch block is not exclusionary if there are 
no abnormal ECG findings and there is no clinical history or 
evidence on physical examination to indicate cardiac disease. 
8. Positive serology results for HIV, HBsAg, or HCV antibodies 
9. Febrile illness with temperature ≥38°C within 7 days of dosing 
10. Female subject who is pregnant or breastfeeding 
11. Donated blood or plasma within 56 days of enrollment  
12. Known allergic reactions to any of the study product components present 
in the formulation or in the processing, as listed in the Investigator 
Brochure  
13. Treatment with another investigational drug within 28 days of dosing 


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14. Treatment with a monoclonal antibody within 3 months of enrollment 
15. Positive serology results for SARS-CoV-2 antibodies (Not applicable for 
Cohort 5). 
16. Positive results from a reverse transcriptase polymerase chain reaction 
(RT-PCR) test for SARS-CoV-2  
17. Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood 
transfusion within 6 months or within 5 half-lives of the specific product 
given 
18. Active drug or alcohol use disorder or dependence that, in the opinion of 
the investigator, would interfere with adherence to study requirements 
19. Use of H1 antihistamines or beta-blockers within 5 days of dosing 
20. Use of any prohibited medication within 28 days prior to screening or 
planned use during the study period 
• Note: Prohibited medications include immunosuppressives (except 
Nonsteroidal Anti-Inflammatory Drugs [NSAIDS]); immune 
modulators; oral corticosteroids (topical/intranasal steroids are 
acceptable); anti-neoplastic agents 
21. Any specific condition that in the judgment of the investigator precludes 
participation because it could affect subject safety 
22. Plans to enroll or is already enrolled in another clinical trial that could 
interfere with safety assessment of the investigational product at any time 
during the study period 
• Note: Includes trials that have a study intervention such as a drug, 
biologic, or device 
23. Is a study site employee or staff 
• Note: Site employees or staff include the PIs and sub-investigators 
or staff who are supervised by the PI or Sub-Investigators 
24. Received an approved COVID-19 vaccine (subjects can receive an 
approved COVID-19 vaccine after completing their Day 90 visit). For 
Cohort 5, subjects who received a COVID-19 vaccine within 14 days 
prior to enrollment are excluded. 


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1. 
KEY ROLES 
ICON Medical Monitor: 
 
 
Priyumvada Naik, MD  
ICON, Plc. 
320 Seven Springs Way 
Suite 500 
Brentwood, TN 
Telephone:  616-309-3831 
Email: priyumvada.naik@iconplc.com  
 
Resilience Government Services 
Medical Lead: 
 
 
 
Wael El-Amin, MD 
Resilience Government Services, Inc. 
13200 NW Nano Court 
Alachua, FL 32615 
Telephone:   240-885-1221 
Email:   wael.el-amin@resilience.com   
 
CRO Safety and 
Pharmacovigilance Contractor: 
 
 
ICON Pharmacovigilance & Safety Services 
Unit 2, Globeside Business Park 
Marlow 
SL7 1HZ 
United Kingdom 
PV email:  ICON-Safety-CentralReceipt@iconplc.com  
 


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Laboratory for Safety Testing: 
 
COVID-19 Testing 
 
Research Laboratory for PK and 
ADA Samples: 
 
 
Laboratory for 
Microneutralization  Samples: 
Local laboratories to be used for safety testing 
 
Local laboratories to be used for safety testing 
 
Resilience Government Services, Inc. 
2061 Challenger Drive, Suite 101 
Alameda, CA 94501 
 
Battelle Biomedical Research Center 
1425 State Route 142 
West Jefferson, OH 43162 
 


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2. 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
2.1. 
Background Information 
2.1.1. 
  Introduction 
Coronavirus disease 2019 (COVID-19) is caused by infection with a novel coronavirus, severe 
acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was first detected in Wuhan 
city, Hubei province, China in 2019. As of June 24, 2022, 539 million cases and 6.3 million 
deaths attributed to COVID-19 have been reported globally, with 85.5 million cases and 1 
million deaths in the US. SARS-CoV-2 is transmitted primarily via respiratory droplets and 
contact with infectious individuals or fomites1. COVID-19 commonly manifests with fever, 
cough, or fatigue, and illness severity ranges from mild (including mild pneumonia) to critical 
(including acute respiratory distress syndrome [ARDS] and multiorgan dysfunction), with older 
adults and patients with serious chronic medical conditions at higher risk of adverse outcomes2. 
The mean incubation time from exposure to onset of symptoms is approximately 5 days3. Viral 
load in posterior oropharyngeal saliva samples is highest in the first week after symptom onset, 
declining gradually thereafter and remaining detectable for at least 20 days in some patients4. It 
has been observed that the viral load can increase for up to 12 days in naïve patients5. SARS-
CoV-2 transmission may occur from asymptomatic or pre-symptomatic individuals and is 
associated with younger age2. In addition, high SARS-CoV-2 titers have been detected in 
oropharyngeal samples early in the disease course5,6. The current estimated basic reproduction 
number is 2.2, so SARS-CoV-2 is expected to continue spreading.7  
 
1 WHO, 2020. Modes of transmission of virus causing COVID-19: implications for IPC precaution 
recommendations. Accessed 2022 June 24. https://www.who.int/news-room/commentaries/detail/modes-
of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations. 
2 CDC, 2020. Interim clinical guidance for management of patients with confirmed coronavirus 
disease (COVID-19). Accessed 2020 April 3. https://www.cdc.gov/coronavirus/2019-
ncov/hcp/clinical-guidance-management-patients.html 
3 Zhang et al. Evolving epidemiology and transmission dynamics of coronavirus disease 2019 
outside Hubei province, China: a descriptive and modelling study. Lancet Infect Dis. 2020 Apr 2. 
[Epub ahead of print] 
4 To et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum 
antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet 
Infect Dis. 2020 Mar 23. [Epub ahead of print] 
5 Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, et al. First case of 2019 novel 
coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. 
6 Zou L, Ruan F, Huang M, Liang L, Huang H, et al. SARS-CoV-2 viral load in upper respiratory 
specimens of infected patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. 
7 Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 
Mar 26;382(13):1268-1269. 
 


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SARS-CoV-2 belongs to the Betacoronavirus genus of single-stranded RNA viruses along with 
SARS-CoV, which caused the global epidemic of SARS that originated in Guangdong province, 
China in 2002; Middle East respiratory syndrome coronavirus (MERS-CoV), which has been 
recognized as causing outbreaks in and near the Arabian peninsula since 2012; and various 
SARS-related coronaviruses (SARSr-CoV) in humans, bats, and other animals8,9,10. 
Betacoronaviruses are subdivided into A, B, C, and D lineages. SARS-CoV and SARS-CoV-2 
belong to the B lineage and MERS-CoV to the C lineage11. The natural reservoir for SARS-CoV 
is the horseshoe bat, with civets and racoon dogs acting as intermediate hosts12. For MERS-CoV, 
the dromedary camel is the reservoir host, although bats may have been the original reservoir13. 
For SARS-CoV-2, the bat is a likely natural reservoir, with pangolins potentially serving as 
intermediate hosts14. Horseshoe bat coronavirus (RaTG13) found in Yunnan province, China 
bears 96.2% sequence identity to SARS-CoV-2 isolated from patients in Wuhan city based on 
genome-wide comparison11; however, pangolin coronaviruses found in Guangdong are more 
similar in their receptor-binding domains14. Thus, while wet markets were implicated in the 
SARS epidemic10 and suspected in the current pandemic14the illegal market for pangolins may 
be the proximal origin of COVID-1915,14. 
2.1.2. 
  Currently Available Treatments 
At the initiation of this protocol, there were no FDA-approved treatments for or vaccines against 
COVID-19, nor were there any for SARS or MERS. On May 1, 2020 the FDA issued an 
Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir for the 
treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized 
 
8 Lan J, Ge J, Yu J, Shan S, Zhou H, et al. Structure of the SARS-CoV-2 spike receptor-binding 
domain bound to the ACE2 receptor. Nature. 2020 Mar 30. doi: 10.1038/s41586-020-2180-5. 
[Epub ahead of print] 
9 WHO, 2020. Middle East respiratory syndrome coronavirus (MERS-CoV). Accessed 2020 
April 3. https://www.who.int/emergencies/mers-cov/en/ 
10 Xu RH, He JF, Evans MR, Peng GW, Field HE, et al. Epidemiologic clues to SARS origin in 
China. Emerg Infect Dis. 2004 Jun;10(6):1030-7. 
11 Zhou P, Yang XL, Wang XG, Hu B1, Zhang L. A pneumonia outbreak associated with a new 
coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. 
12 Guan Y, Zheng BJ, He YQ, Liu XL, Zhuang ZX et al. Isolation and characterization of viruses 
related to the SARS coronavirus from animals in southern China. Science. 2003 Oct 
10;302(5643):276-8. 
13 Kandeil A, Gomaa M, Nageh A, Shehata MM, Kayed AE, et al. Middle East Respiratory 
Syndrome Coronavirus (MERS-CoV) in dromedary camels in Africa and Middle East. Viruses. 
2019 Aug 5;11(8). pii: E717. 
14 Lam TT, Shum MH, Zhu HC, Tong YG, Ni XB, et al. Identifying SARS-CoV-2 related 
coronaviruses in Malayan pangolins. Nature. 2020 Mar 26. doi: 10.1038/s41586-020-2169-0. 
[Epub ahead of print] 
15 Andersen KG, Rambaut A, Liplin WI, Holmes EC, Garry RF. The proximal origin of SARS-
CoV-2. Nat Med. 2020 Mar 17. https://doi.org/10.1038/s41591-020-0820-9. [Epub ahead of print] 


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with severe disease. While there is limited information known about the safety and effectiveness 
of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was 
shown in a clinical trial to shorten the time to recovery in some patients.  
Currently, there are multiple vaccines for the protection against and several mAbs available for 
the treatment and prophylaxis of COVID-19 that are available under emergency use 
authorization. 
2.1.3. 
  ADM03820 Development 
ADM03820 drug product is being investigated for the treatment and prevention of COVID-19 in 
adults.  ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-
CoV-2 antibodies, mAb2130 (YTE+LALA) and mAb2381 (YTE+LALA), individually 
expressed in a Chinese hamster ovary (CHO) cell line. Several amino acid changes in the Fc 
region have been incorporated into mAb2130 (YTE+LALA)and mAb2381 (YTE+LALA) to 
silence or reduce the effector function of antibodies. The LALA variant eliminates complement 
binding and fixation as well as Fc-γ dependent antibody-dependent cell-mediated cytotoxicity 
(ADCC) in both murine IgG2a and human IgG116. The YTE mutation was also incorporated to 
extend circulating half-life of the antibodies17. RGS worked with Vanderbilt University Medical 
Center (VUMC), Just-Evotec, ATUM, and Seromyx to develop the ADM03820 anti-SARS-
CoV-2 mAbs. 
A GLP repeat dose toxicity study was performed to evaluate the safety of ADM03820 in rats 
when administered by intramuscular injection or intravenous infusion once weekly for three 
weeks and to evaluate toxicity and reversibility of effects after a 72-day recovery period.   
2.1.4. 
  Public Readiness and Emergency Preparedness Act 
This protocol and the study product tested are covered under the Public Readiness and 
Emergency Preparedness (PREP) act.  The PREP Act provides compensation to participants in 
the event of serious physical injury or death caused by covered drugs and vaccines, and liability 
protection for persons conducting the clinical trial and the manufacturer of the drug or vaccine. 
The PREP act provides immunity for covered persons (such as Manufacturers, Distributers, 
Program planners and other qualified persons who prescribe, administer or dispense the study 
product) from tort liability, unless the injury was caused by willful misconduct. 
 
16 Lo M, Kim HS, Tong RK, Bainbridge TW, Vernes J-M, Zhang Y, Lin YL, Chung S, Dennis 
MS, Zuchero YJY, Watts RJ, Couch JA, Meng YG, Atwal JK, Brezski RJ, Spiess C, Ernst JA. 
2017. Effector-attenuating substitutions that maintain antibody stability and reduce toxicity in 
mice. J Biol Chem 292:3900 –3908. https://doi.org/10.1074/jbc.M116.767749. 
 
17 Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, et al. Safety, tolerability, and 
pharmacokinetics of MEDI4893, an investigational, extended-half-life, anti-staphylococcus 
aureus alpha-toxin human monoclonal antibody, in healthy adults. Antimicrob Agents 
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The PREP Act also authorized a “Covered Countermeasures Process Fund” to provide 
compensation to eligible individuals who suffer specified injuries from administration or use of a 
countermeasure pursuant to the declaration.  Any requests for compensation must be filed within 
one year of administration or use of the countermeasure.  Requests would go to the HRSA 
Preparedness Countermeasures Injury Compensation Program (http://www.hrsa.gov/cicp).  
Compensation may then be available for medical benefits, lost wages and death benefits to 
eligible individuals for specified injuries in accordance with regulations published by the 
Secretary.  Eligibility for compensation and the injuries for which compensation may be 
available are further defined by regulation. 
An individual who suffers a serious physical injury or death from the administration and use of 
the study product must first seek compensation from the Covered Countermeasures Process 
Fund.  A serious physical injury means an injury that is life threatening, results in, or requires 
medical or surgical intervention to prevent, permanent impairment of a body function or 
permanent damage to body structure.  Any compensation will be reduced by public or private 
insurance or worker’s compensation available to the injured individual. 
If no funds have been appropriated to the compensation program, the Secretary does not make a 
final determination on the individual’s request within 240 days, or if the individual decides not to 
accept the compensation, the injured individual or his representative may pursue a tort claim in 
the US District Court for the District of Columbia, but only if the claim involves willful 
misconduct, is pled with particularity required under the PREP Act, verified, and accompanied 
by an affidavit by a physician who did not treat the individual and certified medical records.  
Any award is reduced by any public or private insurance or worker’s compensation available to 
the injured individual.  Awards for non-economic damages, such as pain, suffering, physical 
impairment, mental anguish, and loss of consortium are also limited.  If the individual accepts 
compensation, or if there is no willful misconduct, the individual does not have a tort claim that 
can be filed in a US Federal or a State court. 
2.2. 
Rationale for Use of ADM03820  
Antibodies from convalescent patients have been shown to lower or mediate the infectivity of the 
virus18, and their presence in respiratory mucosa may also protect ACE2 receptor-presenting 
cells. Studies performed at VUMC showed that antibodies that block attachment of the virus to 
Hace2-presenting host cells by binding to the region of the receptor-binding domain of the S 
protein (SRBD) demonstrated neutralizing activity in a rapid screening assay with authentic 
SARS-CoV-219. Further analysis demonstrated that the SARS-CoV-2 SRBD contained three 
major antigenic sites. By utilizing antibodies non-competitively binding to different antigenic 
 
18 Ou et al. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-
reactivity with SARS-CoV. Nat Commun. 2020 Mar 27;11(1):1620. 
19 Crowe JE, Carnahan RH, Zost SJ, Gilchuk P, et al. Potently neutralizing human antibodies that 
block SARS-CoV-2 receptor binding and protect animals. bioRxiv. 2020 May 22. 
https://doi.org/10.1101/2020.05.22.111005. [Epub ahead of print] 
 


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sites the researchers were able to demonstrate synergistic response potentially lowering the dose 
of each mAb three-fold19. The long mean incubation time of the disease also provides a 
prolonged time for inactivation by circulating systemic antibodies. Therefore, there is a strong 
rationale for developing monoclonal antibodies (mAbs) derived from convalescent COVID-19 
patient sera directed against S proteins, and perhaps a combination of multiple antibodies, some 
directed to the S1/S2 site. 
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 
antibodies, mAb2130 (YTE+LALA) and mAb2381 (YTE+LALA), individually expressed in a 
Chinese hamster ovary (CHO) cell line. Several amino acid changes in the Fc region have been 
incorporated into mAb2130 (YTE+LALA) and mAb2381 (YTE+LALA) to silence or reduce the 
effector function of antibodies. The LALA variant eliminates complement binding and fixation 
as well as Fc-γ dependent antibody-dependent cell-mediated cytotoxicity (ADCC) in both 
murine IgG2a and human IgG1.16 The YTE mutation was also incorporated to extend circulating 
half-life of the antibodies.17 
The proposed starting dose for ADM03820 dose escalation (150 mg IM) is based on previous 
toxicology studies, known safety profile of mAbs, and the expected potency of ADM03820. 
Based on the expected potency of ADM03820, the doses proposed for evaluation are anticipated 
to support PK analysis with microneutralization values (TCID50) in therapeutic window for a 
prophylactic.  Provided there are no safety concerns, dosing will escalate to 300 mg and 600 mg 
IM.  
2.3. 
Potential Risks and Benefits 
2.3.1. 
  Potential Risks 
The potential risks to the subjects due to participation in the study are those related to 
venipuncture, the IM injection, the administration of ADM03820, and a theoretical possibility of 
enhanced disease by antibody-dependent enhancement (ADE). 
Venipuncture 
Venipuncture causes transient discomfort and may cause fainting.  Bruising at the site of the 
venipuncture may occur but can be prevented or lessened by applying pressure for several 
minutes. Infection at the site is possible but highly unlikely as aseptic technique must be 
employed. 
IM Injection 
An IM injection may cause some discomfort at the injection site.  Other risks may include pain, 
redness, swelling, or warmth at the injection site.  These risks are minimal. 
An IM injection into the gluteus medius may cause sciatic nerve damage, bleeding, hematoma, 
or infection.  
Effects of ADM03820 


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As ADM03820 has not been administered to humans, the potential risks are primarily based on 
adverse events associated with administration of other antibody products, especially infusion 
reactions. 
Immunogenicity, the elicitation of antibodies directed against ADM03820 may occur following 
injection. ADM03820 is a combination of two human IgG1 antibodies, which based on 
experience with other humanized or chimeric mAbs, reduces the immunogenic potential. 
ADE of virus infection of cells or disease in animal models occurs with other coronaviruses. 
Low levels of antibody directed against SARS-CoV-2 may increase virus infection of human 
cells cultured in the laboratory. Some studies have shown that administration of antibodies 
directed against SARS-CoV-2 can increase the severity of disease or levels of the virus in 
challenged animals.   Although ADE of SARS-CoV-2 infection or COVID-19 has not been 
shown to occur in humans, the LALA mutation in ADM03820, by reducing potential Fc-receptor 
binding of ADM03820-SARS-CoV-2 complexes, may mitigate this potential risk.20 
2.3.2. 
Known Potential Benefits 
This trial has no benefit for the subjects participating in the trial.  The knowledge gained in this 
trial may help society, especially those exposed to, or at risk of being exposed to COVID-19. 
3. 
OBJECTIVES 
3.1. 
Study Objectives 
Primary Objective:   
• To assess the safety and tolerability of different doses of ADM03820 in healthy adult 
subjects. 
Secondary Objective: 
• To assess the pharmacokinetic (PK) and immunogenicity of different doses of 
ADM03820 in healthy adult subjects. 
3.2. 
Study Outcome Measures 
3.2.1. 
Primary Endpoints 
• The occurrence of Serious Adverse Events following administration of ADM03820 to 
the final follow-up visit. 
• The occurrence of Adverse Events from administration of ADM03820 to the final 
follow-up visit. 
 
20 Eroshenko, N., Gill, T., Keaveney, M. Church, et al. , Implications of Antibody-Dependent 
Enhancement of Infection for SARA-CoV-2 Countermeasures.  Nature biotechnology. 05 June 2020. 
https://www.nature.com/articles/s41587-020-0577-1  
 


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• The occurrence of changes from baseline in physical examination, vital signs and 
clinical safety laboratory values following administration of ADM03820 to the final 
follow-up visit. 
3.2.2. 
Secondary Endpoints 
• The assessment of Cmax, Tmax and AUC(0-t) for total antibodies of ADM03820 as 
measured by enzyme-linked immunosorbent assay (ELISA) for samples from Cohorts 
1 and 2. The assessment of Cmax, Tmax and AUC(0-t) for each of the monoclonal 
antibodies  of ADM03820 as measured by enzyme-linked immunosorbent assay 
(ELISA) for samples from Cohort 3, Cohort 4, and Cohort 5. 
− Pharmacokinetic samples will be tested by ELISA at pre-dose, 2, 4, 8, and 24 
hours post dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365 
for all cohorts 
− Samples will be tested by Microneutralization at pre-dose and Days 2, 15, 30, 60, 
90, 120, 150, and 180 for all cohorts 
• Samples will be tested by Electrochemiluminescence Assay (ECLA) to evaluate 
presence of anti-drug antibodies (ADA) collected for all cohorts. 
− ADA samples will be tested at pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, 
180, 365 for all cohorts 
• Incidence of the first case of SARS-SoV-2 RT-PCR positive symptomatic illness 
occurring after dosing through Day 365 
• Incidence of SARS-CoV-2 RT-PCR positive severe or critical symptomatic illness 
occurring after dosing through Day 365 
• Incidence of COVID-19 related Emergency Department visits occurring after dosing 
through Day 365 
4. 
STUDY DESIGN 
This is a Phase 1, randomized, double-blind, placebo-controlled study of five dose cohorts to 
evaluate the safety, tolerability, and immunogenicity of ADM03820 in healthy adults. This is a 
first-in-human study and each subject will receive a single dose of ADM03820 or placebo.   
The study will randomize a total of 50 healthy subjects to receive an intramuscular (IM) injection 
of either ADM03820 or placebo.   
Table 1: 
Cohorts 
Cohort 
Dose of ADM03820  
Number of Subjects 
1 
150 mg IM injection 
10 subjects (8 active, 2 placebo) 
2 
300 mg IM injection 
10 subjects (8 active, 2 placebo) 


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3 
300 mg IM injection 
10 subjects (8 active, 2 placebo) 
4 
300 mg IM injection 
10 subjects (8 active, 2 placebo) 
5 
600 mg IM injection 
10 subjects (8 active, 2 placebo) 
 
Schedule for Subjects 
Subjects in cohorts 1-4 will participate in the study for approximately 554 days, including a 14-
day screening period. Subjects in cohort 5 will participate in the study for approximately 379 
days, including a 14-day screening period. All subjects in the study will have a 24-hour stay in 
the clinic after dosing is complete to ensure that no hypersensitivities or safety signals occur.  
Follow-up outpatient visits for all cohorts will occur on Days 3, 4, 8, 15, 30, 45, 60, 90,120, 150, 
180, and 365 with cohorts 1-4 having additional telephone visits on Days 450 and 540. The last 
outpatient follow up visit is scheduled at Day 365.  The end of the study is defined as the date of 
the last visit of the last subject in the study. 
There are several blinded interim analyses planned for this study.  A blinded interim analysis is 
planned to analyze all PK samples through Day 30 for all subjects in Cohorts 1 – 2.  A second 
blinded interim analysis is planned to analyze all PK samples after all subjects in Cohorts 1-3 
complete Day 60. A third interim analysis is planned to analyze safety and PK after all subjects 
in cohort 5 complete Day 60. 
There is also an interim clinical study report (CSR) planned after subjects in Cohorts 1 through 4 
complete Day 90. 
Schedule for Cohorts 
Since this is a first-in-human study, administration of the study products to subjects in cohorts 1, 
2 and 5 will occur to allow careful observation of individuals for adverse events.  Two sentinel 
subjects within each cohort will be admitted and administered a dose on Day 1 to remain in the 
clinic until Day 2.  The randomization scheme will be designed to ensure that one subject will 
receive ADM03820 and the other will receive placebo.  The IM dosing of the remaining subjects 
within cohorts 1, 2, and 5 will not be initiated until at least 48 hours have passed and no adverse 
events have occurred that meet halting criteria, and no safety signals have occurred that in the 
opinion of the investigator warrant further investigation.   The remaining subjects within each 
specific cohort will be dosed at least four hours apart until all subjects in the cohort have been 
dosed.   An alternate subject will be admitted to the unit for each two-subject group. Dose 
escalation will not occur until safety data through Day 8 is reviewed by the SRC. 
Cohort 1 (150 mg IM injection) will be dosed first. Two sentinel subjects (one ADM03820 and 
one placebo) will each be administered a single 3 mL IM injection. The dosing of the next 
subjects within Cohort 1 will not be initiated until at least 48 hours have passed and no adverse 
events have occurred that meet halting criteria and no safety signals have occurred that in the 


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opinion of the investigator warrant further investigation.  The remaining subjects in the cohort 
will be dosed at least four hours apart until all subjects in the cohort have been dosed.   
Dose escalation to Cohort 2 will not occur until safety data through day 8 for Cohort 1 is 
reviewed by the SRC.  Objective dose escalation criteria and safety evaluations will be utilized.   
In Cohort 2 (300 mg IM injection), two sentinel subjects (one ADM03820 and one placebo) will 
each be administered two 3 mL IM injections.  Dosing for the remaining subjects in Cohort 2 
will be initiated after at least 48 hours have passed and no adverse events have occurred that 
meet halting criteria and no safety signals have occurred that in the opinion of the investigator 
warrant further investigation.  The remaining subjects in the cohort will be dosed at least four 
hours apart until all subjects in the cohort have been dosed.   
Dosing for Cohort 3 (300 mg IM injection) will not occur until safety data through day 8 for 
Cohort 2 is reviewed by the SRC.  Objective safety evaluations will be utilized.  Subjects in 
Cohort 3 will be scheduled based on the SRC recommendation and will each be administered 
two 3 mL IM injections without delay. 
Dosing for Cohort 4 (300mg IM injection of drug product concentrated at 100mg/mL) will occur 
without delay.  Subjects in Cohort 4 will be administered a single 3mL IM injection.  
In Cohort 5 (600 mg IM injection of drug product concentrated at 100mg/mL), two sentinel 
subjects (one ADM03820 and one placebo) will each be administered two 3 mL IM injections.  
Dosing for the remaining subjects in Cohort 5 will be initiated after at least 48 hours have passed 
and no adverse events have occurred that meet halting criteria and no safety signals have 
occurred that in the opinion of the investigator warrant further investigation.  The remaining 
subjects in the cohort will be dosed at least four hours apart until all subjects in the cohort have 
been dosed.   The SRC will review safety data through day 8 for subjects in cohort 5 prior to the 
initiation of the phase 2 protocol. 
5. 
STUDY ENROLLMENT AND WITHDRAWAL 
Only subjects who meet all of the inclusion and none of the exclusion criteria will be eligible for 
enrollment into this study.  Exemptions may be granted on Inclusion/Exclusion Criteria pending 
Medical Lead Approval.  
This study will enroll fifty healthy male and female subjects ages 18 to 55 years old in five 
cohorts.   
Alternates who meet all eligibility criteria may effectively have their check-in at the same time 
as the lead two subjects and be rolled over into the next group within that cohort but will not be 
dosed until dosing for that cohort begins.   Alternates not enrolled into the cohort are eligible for 
enrollment in subsequent cohorts but would have to undergo re-screening if more than 14 days 
have passed since their initial screening visit. 
5.1. 
Subject Inclusion Criteria 
All must be answered yes for the subject to be eligible for study participation 


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1. Informed consent understood and signed 
2. Healthy male or healthy, non-pregnant, non-lactating female 
3. Willingness to comply and be available for all protocol procedures for the duration of the 
study 
4. Between 18 and 55 years of age on the day of dosing 
5. Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2  
6. Female subjects of childbearing potential must have a negative serum pregnancy test at 
screening and negative urine test on Day 1 prior to dosing 
• Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 
year without menses or without other known or suspected cause and appropriately 
elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy 
7. Females of childbearing potential and males agree to use acceptable contraception for the 
duration of the study. 
• Note: These include progestin implants, intrauterine devices (IUDs), surgical 
(hysterectomy or tubal ligation; vasectomy) or abstinence. Use of methods such as 
progestin injectables, combined oral hormonal contraceptives, condoms, and 
diaphragms will not be acceptable when used alone, but they could be considered, if 
used in combination with another method (for example, a female using combined oral 
contraceptives if her male partner is sterile, or if she and her non-sterile male partner 
use a double-barrier method), after consultation with the RGS ML. All males will be 
required to use a barrier method (condoms) for the duration of the study 
8. Screening laboratory tests are within normal ranges or outside the normal ranges and 
considered not clinically significant by the Principal Investigator 
• If urinalysis by dipstick is abnormal, a complete urinalysis with microscopic 
evaluation will be performed and the results will supersede the results of the dipstick 
for blood, glucose, and protein. 
• Menstruating females failing inclusion criteria due to positive blood on urine test may 
be retested following cessation of menses.   
• Other laboratory values that are outside the range of eligibility but are thought to be 
due to an acute condition or collection or laboratory error may be repeated once. 
9. The urine drug screen is negative 
10. Breathalyzer test or blood/saliva alcohol test is negative and subjects agrees to abstain 
from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any 
study visit 
11. Agree to minimize risk of SARS-CoV-2 infection 


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5.2. 
Subject Exclusion Criteria 
Subjects meeting any of the following exclusion criteria are not eligible for participation. 
All must be answered no for the subject to be eligible for study participation 
1. History of a chronic medical condition that would either interfere with the accurate 
assessment of the objectives of the study or increase the risk profile of the subject. 
2. Subjects with cardiovascular disease 
3. Subjects with diabetes 
4. Subjects with pulmonary diseases such as COPD or asthma 
5. History of severe allergic reaction of any type to medications, bee stings, food, or 
environmental factors or hypersensitivity or reaction to immunoglobulins.   
6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a 
QTc interval >450 milliseconds) 
7. Clinically significant abnormal electrocardiogram at screening.  
• Note: Clinically significant abnormal ECG results include but not limited to: 
complete left or right bundle branch block; other ventricular conduction block; 2nd 
degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; 
sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern 
of ST elevation felt consistent with cardiac ischemia; or any condition deemed 
clinically significant by a study investigator 
• Incomplete right bundle branch block is not exclusionary if there are no abnormal 
ECG findings and there is no clinical history or evidence on physical examination to 
indicate cardiac disease. 
8. Positive serology results for HIV, HbsAg, or HCV antibodies 
9. Febrile illness with temperature ≥38°C within 7 days of dosing 
10. Female subject is pregnant or breastfeeding 
11. Donated blood or plasma within 56 days of enrollment 
12. Known allergic reactions to any of the study product components present in the 
formulation or in the processing, as listed in the Investigator Brochure  
13. Treatment with another investigational drug within 28 days of dosing 
14. Treatment with a monoclonal antibody within 3 months of enrollment.  
15. Positive serology results for SARS-CoV-2 antibodies (Not applicable for Cohort 5). 
16. Positive results from a reverse transcriptase polymerase chain reaction (RT-PCR) test for 
SARS-Co-V-2 


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17. Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion 
within 6 months or within 5 half-lives of the specific product given 
18. Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, 
would interfere with adherence to study requirements 
19. Use of H1 antihistamines or beta-blockers within 5 days of dosing 
20. Use of any prohibited medication within 28 days prior to screening or planned use during 
the study period 
• Note: Prohibited medications include immunosuppressives (except Nonsteroidal 
Anti-Inflammatory Drugs [NSAIDS]); immune modulators; oral corticosteroids 
(topical/intranasal steroids are acceptable); anti-neoplastic agents  
21. Any specific condition that in the judgment of the investigator precludes participation 
because it could affect subject safety 
22. Plans to enroll or is already enrolled in another clinical trial* that could interfere with 
safety assessment of the investigational product at any time during the study period 
• Note: Includes trials that have a study intervention such as a drug, biologic, or device 
23. Is a study site employee or staff 
• Note: Site employees or staff include the Pis and sub-investigators or staff who are 
supervised by the PI or Sub-Investigators 
24. Received an approved COVID-19 vaccine (subjects can receive an approved COVID-19 
vaccine after completing their Day 90 visit. For Cohort 5, subjects who received a 
COVID-19 vaccine within 14 days prior to enrollment are excluded. 
5.3. 
Treatment Assignment Procedures 
5.3.1. 
Randomization Procedures 
Randomized treatment assignments will be generated by a statistician at ICON.  Randomization 
will occur following admittance to the unit and confirmation of eligibility is confirmed. 
This is a Phase 1 double-blinded, placebo-controlled trial that will randomize subjects within five 
dosing cohorts to either active or placebo.  
Cohorts 1, 2, and 5 
For cohorts 1, 2, and 5, the first two subjects will be randomized in a 1:1 fashion to active and 
placebo to ensure that one of the first two subjects receives active treatment and the other 
control.  An alternate subject will be admitted to the unit for each two-subject group.  If one of 
the first two subjects is not randomized for any reason, then the alternate subject will receive the 
next consecutive randomization number. The product assignment of the remaining subjects in 
each cohort will follow a 7:1 randomization of active to placebo, respectively.  The 
randomization list will be generated by the unblinded study biostatistician and uploaded to IRT 


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system by vendor (4G Clinical). Upon confirming eligibility of subjects, site research personnel 
will randomize subjects then the unblinded study pharmacist will be notified of treatment 
allocation via system-generated email.   
Cohort 3 and 4 
Subjects in cohort 3 and 4 will be randomized in a 4:1 ratio of active to placebo.  The 
randomization list will be generated by the unblinded study biostatistician and uploaded to IRT 
system by vendor (4G Clinical). Upon confirming eligibility of subjects, site research personnel 
will randomize subjects then the unblinded study pharmacist will be notified of treatment 
allocation via system-generated email.   
5.3.2. 
Masking Procedures 
The study staff participating in the administration of study product and assessment of the 
subjects will not be aware of the contents of the vial.  The ADM03820 and placebo will look 
identical, so the study staff and the subject will not be able to determine whether placebo or 
ADM03820 is being injected. 
The Investigator may unblind a subject’s treatment assignment only in the case of an emergency 
or SAE, when knowledge of the study treatment is essential to the appropriate clinical 
management or welfare of the subject.  Whenever possible, the Investigator should first discuss 
the options with the ICON GPHS Medical Monitor and the RGS ML or appropriately designated 
RGS personnel before unblinding the subject’s treatment assignment.  If this is impractical, the 
Investigator must notify the ICON GPHS Medical Monitor and RGS as soon as possible but 
without revealing the subject’s treatment assignment.  The date and reason for unblinding must 
be recorded on the SAE form.  
5.3.3. 
Reasons for Withdrawal 
A subject may withdraw from the study at any time for any reason, without any consequence.  
A study subject will be discontinued from participation in the study if any of the following 
reasons occur prior to dosing: 
• Development of any exclusion criteria;  
• Request by the subject to terminate participation; 
• Requirement for prohibited concomitant medication or treatment; 
A subject may be removed from the study for the following reasons post dosing; however, 
whenever possible the subject should be followed for safety per protocol: 
• Failure to adhere to the protocol requirements 
• Lost to follow-up; 
• Request of primary care provider; 


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• At the request of the Institutional Review Board (IRB)/Ethics committee, Food and 
Drug Administration (FDA), or DOD; 
• The subject’s well-being based on the opinion of the investigator;  
• The occurrence of a Serious Adverse Event (SAE) or (AE warranting withdrawal). 
5.3.4. 
Handling of Withdrawals  
Subjects who are withdrawn prior to dosing must be replaced.  
Following dosing, one subject per cohort may withdraw prior to the completion of Visit 11 (day 
60) or was noncompliant with all PK draws through Visit 6 (day 4) without being replaced.   
If 4 or more subjects withdraw, are lost to follow up or terminate prior to Day 8 within a cohort, 
at least one of those subjects need to be replaced to ensure that data for at least 7 subjects are 
available for review. 
If 4 or more subjects withdraw, are lost to follow up or terminate on or after Day 8 but prior to 
Day 60 or are not compliant with all PK draws through Day 15 within a cohort, they should be 
replaced.   
If more than 4 subjects withdraw, are lost to follow up or terminate following the Day 8 SRC 
review of safety data within a cohort, the site will attempt to replace those subjects in that dose 
group at the time of the next planned cohort. 
All replaced subjects will be assigned to the same treatment assignment as the subject they are 
replacing. This will be documented in the source documents and eCRFs. 
5.3.5. 
Lost to Follow-up 
In the case of subjects who fail to appear for a follow-up assessment, extensive effort (i.e., three 
documented contact attempts via phone calls, e-mail, etc., made on separate occasions and 
followed by a certified letter) will be made to locate or recall them, or at least to determine their 
health status.  These efforts will be documented in the subjects’ records. 
5.3.6. 
Termination of Study  
Although the study Sponsor has every intention of completing the study, it reserves the right to 
terminate the study at any time for clinical or administrative reasons. 
6. 
STUDY PRODUCTS 
6.1. 
Description of Study Products 
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive anti-SARS-CoV-2 antibodies 
formulated as 50 mg/mL or 100 mg/mL strength solutions in a 2 mL vial for IM administration. 
The drug product is a clear to opalescent, slightly colored, sterile aqueous solution at Ph 6. 
ADM03820 is formulated in 141 Mm L-arginine, 10 Mm sodium succinate buffer, with 0.25% 
v/v Polysorbate 80 and is filled as 1.2 mL in a 2 mL vial (50 mg/mL) or 1.7 mL in a 2 mL vial 
(100 mg/mL).  


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Placebo is 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of 
sodium chloride and water for injection.   
6.2. 
Acquisition 
The ADM03820 will be supplied by Resilience Government Services (Previously Ology 
Bioservices, Inc.) Study product will be shipped to the site. 
The normal saline for injection will be supplied by the study site. 
6.3. 
Formulation, Packaging, and Labeling 
ADM03820 
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive anti-SARS-CoV-2 antibodies 
formulated as 50 mg/mL or 100 mg/mL strength solutions in a 2 mL vial for IM administration. 
The drug product is a clear to opalescent, slightly colored, sterile aqueous solution at Ph 6. 
ADM03820 is formulated in 141 Mm L-arginine, 10 Mm sodium succinate buffer, with 0.25% 
v/v Polysorbate 80 and is filled as 1.2 mL in a 2 mL vial (50 mg/mL) or 1.7 mL in a 2 mL vial 
(100 mg/mL).  
The drug product will be supplied in 2-mL, pyrogen-free, Type 1 glass vials fitted with Teflon-
coated butyl rubber stoppers and flip-up aluminum seals.   
ADM03820 will be administered by intramuscular (IM) injection as follows: 150 mg (Cohort 1 
as 1 x 3 mL IM injection) or 300 mg (Cohorts 2 and 3 as 2 x 3 mL IM injections or Cohort 4 as 1 
x 3mL IM injection) or 600 mg (Cohort 5 as 2 x 3 mL IM injections).  
Placebo (Normal Saline, 0.9% Sodium Chloride, USP) 
0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium 
chloride and water for injection.  Each mL contains sodium chloride 9 mg and contains no 
preservatives, bacteriostatic, antimicrobial agent, or added buffer.  The solution is clear in 
appearance with a Ph range of 4.5 to 7.0.    
Placebo will be administered by intramuscular (IM) injection as follows: 150 mg (Cohort 1 as 1 
x 3 mL IM injection) or 300 mg (Cohorts 2 and 3 as 2 x 3 mL IM injections or Cohort 4 as 1 x 
3mL IM injection) or 600 mg (Cohort 5 as 2 x 3 mL IM injections). 
 
6.4. 
Product Storage and Stability 
ADM03820 
Cohorts 1-3 
ADM03820 drug product (50mg/mL) will be shipped frozen and should be stored at -90°C to -
70°C until time of preparation.  If a vial is removed from the freezer it must be used within 1 
hour of thawing.  If not used, it must be quarantined and maintained for study product 
accountability as per Section 6.6. ADM03820 should be protected from direct sunlight. 


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ADM03820 is not light sensitive under normal shipping and storage conditions.  Avoid vigorous 
shaking or agitation. 
Cohorts 4 and 5 Only 
ADM03820 (100mg/mL) drug product will be shipped and should be stored at 2°C to 8°C until 
time of preparation.  If a vial is removed from the refrigerator it must be used within 30 minutes.  
If not used, it must be quarantined and maintained for study product accountability as per 
Section 10.5. ADM03820 should be protected from direct sunlight. ADM03820 is not light 
sensitive under normal shipping and storage conditions.  Avoid vigorous shaking or agitation. 
Placebo (Normal Saline, 0.9% Sodium Chloride, USP) 
Store at 20ºC to 25ºC (68°F to 77ºF) [See USP Controlled Room Temperature; excursions 
between 15°C and 30°C (59°F and 86°F) are permitted].  Protect from freezing. 
6.5. 
Dosage, Preparation and Administration 
The unblinded site Research Pharmacist will prepare the study drug on the same day as 
administration. Prior to using any of the parenteral products, inspect for discoloration or 
particulate matter before use.  Any product that fails inspection should be quarantined at 2-8°C 
for inspection by the Sponsor. Preparation of the product will be performed using aseptic 
technique under a sterile environment (e.g., Biologic Safety Cabinet or laminar flow hood). 
Based on the subject assigned cohort randomization, the appropriate ADM03820 dose will be 
calculated, and the appropriate number of vials will be removed from storage to prepare for 
dosing.  Vials containing ADM03820 should not be vigorously shaken. Any unused portion left 
in the vial should be retained for study product accountability as per Section 6.6. The placebo 
will be normal saline, 0.9% sodium chloride.   
The subjects will be admitted to the Phase 1 unit the day of the planned dosing.  Verification that 
the subject still meets all inclusion criteria and does not have any exclusion criteria must be made 
prior to randomization. The unblinded site Research Pharmacist will prepare the dose as 
described.  Administration of the IM dose of ADM03820 or placebo should be injected into the 
gluteus medius (see Appendix C) and must be completed within 30 minutes of preparation.    
6.6. 
Accountability Procedures for the Study Products 
The Site Principal Investigator is responsible for the distribution and disposition of study product 
(both ADM03820 and placebo) and has ultimate responsibility for accountability.  The site 
Principal Investigator may delegate this responsibility to the unblinded site Research Pharmacist.  
If delegated, the site Research Pharmacist will be responsible for maintaining complete records 
and documentation of study product receipt, accountability, dispensation, temperature 
monitoring, and storage conditions, and final disposition of the study product.   
All study products, whether administered or not, must be documented on the appropriate study 
product accountability record or dispensing log. Used and unused ADM03820 vials and placebo 
vials will be retained until monitored and released for disposition as per requirements.       


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Upon completion of the study and after the final monitoring visit, any remaining unused study 
product will either be returned or destroyed appropriately at the clinical site as per sponsor 
requirements and instructions, or in accordance with disposition plans. 
6.7. 
Assessment of Subject Compliance with Study Product  
Because each dose of ADM03820 will be administered by site personnel, subject compliance is 
not anticipated to be an issue. 
6.8. 
Concomitant Medications 
Concomitant medication information will be recorded at Screening for the prior 28 days.  At 
each subsequent study visit each new concomitant medication and changes to existing 
medications will be recorded.   Subjects will be required not to utilize non-study medication or 
herbal supplements during the study except those deemed necessary by the site PI or sub 
investigator.  Any drug (e.g., over-the-counter herbal supplement, vitamins or prescription) used 
by the subject during the course of the trial will be recorded in the subject’s source documents 
and on the appropriate Ecrf. 
Subjects will be instructed to refrain from the receipt of any of the following during study 
participation unless medically indicated and deemed immediately necessary by their private 
physician: 
• Blood or blood products, 
• Any antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) 
• Monoclonal antibody 
• H1 antihistamines (PRN use of H1 antihistamines may be acceptable after Medical 
Lead/Medical Monitor approval) 
• Beta-blockers 
• Immunosuppressives (except NSAIDS) 
• Oral corticosteroids (topical/intranasal steroids are acceptable) 
• Anti-neoplastic agents 
7. 
STUDY PROCEDURES  
7.1. 
Medical History and COVID-19 Instruction 
Medical history will be obtained by direct interview.  Subjects will be queried regarding a history 
of significant medical disorders of the head, eyes, ears, nose, throat (HEENT), mouth, 
cardiovascular system, lungs, gastrointestinal tract, liver, pancreas, kidney, urologic, nervous 
system, blood, lymph glands, endocrine system, musculoskeletal system, skin, and 
genital/reproductive tract.  A history of any allergies, cancer, immunodeficiency, psychiatric 
illness, substance abuse, and autoimmune disease will be solicited. The medical history will 
include current and past medical diagnoses, hospitalizations and major surgical procedures. 


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Demographic information (date of birth, gender, race, ethnicity) will be obtained as part of the 
medical history assessment.  The medical history will be obtained at screening, updated upon 
admittance to the unit on Day 1, and entered appropriately into the EDC using the CTCAE 
grading scale. 
Because ADE is still being studied, subjects will be instructed to minimize the risk of SARS-
CoV-2 infection. A printed fact sheet from the Centers for Disease Control website “How to 
Protect Yourself & Others” (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-
sick/prevention.html) will be distributed to all study participants and its content reviewed with 
them by study staff.  If a subject acquires COVID-19 during their participation in the study, they 
should seek and obtain the appropriate treatment.   
7.2. 
Physical Examination 
An abbreviated physical examination (PE) will be conducted at the screening visit and Day 1.  
Height and weight will be obtained at screening.  An abbreviated PE is distinguished from a 
complete PE as all body system assessments are not required (e.g., pelvic, rectal, etc.).  On Day 
1, the PE will focus assessment for the presence of the following in order to detect signs of a 
hypersensitivity reaction:  
− General appearance including alertness, diaphoresis, chills, and any difficulty 
breathing.   
−  HEENT (confirm no swelling of lips/tongue/uvula) 
− Chest (confirm no stridor or wheezing) 
− Heart (assess regularity of rhythm) 
− Skin (confirm no hives, examine for any eruptions) 
− Joints (confirm no swelling, warmth, or tenderness) 
A symptom- directed PE will be performed at all other in-clinic study visits.  Refer to the MOP 
for further details on the symptom directed PE.  Any new findings on examination post dosing or 
worsening of existing conditions are to be reported as Aes.   
7.3. 
Vital Signs 
Vital sign assessments including systolic and diastolic blood pressure (BP) [measured after 
sitting for at least 10 minutes], heart rate (HR), respiratory rate, and oral temperature will be 
performed at each in-clinic study visit.  Vital signs that are thought to be aberrant due to an error 
in measurement may be repeated. During screening and follow-up, a measurement that is a 
Grade 1 (as referenced in Appendix B by CTCAE version 5.0) may be repeated once if the PI 
believes a transient condition led to the aberrant value.   
Vital signs obtained at screening will serve as baseline values for the subject.  Grade 1 values are 
allowable unless deemed clinically significant by the study investigator. 


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7.4. 
Electrocardiogram 
A 12-lead ECG will be performed at screening and reviewed by the study PI or a co-Investigator 
to assess the cardiac status of a subject for eligibility for enrollment. ECGs will be performed 
after the subject rests quietly in a supine position for at least 10 minutes. To be eligible for 
participation, the QT interval should be ≤450ms, and there must be no clinically significant ECG 
abnormalities according to the study investigators and may be repeated once.  A 12-lead ECG 
will also be performed after a subject has been dosed.    
7.5. 
Laboratory Evaluations 
Venipuncture schedule and volumes are displayed in Table 2.  
7.5.1. 
 Screening Laboratory Tests 
7.5.1.1. 
Viral Serology Testing 
Subjects will be screened for HIV, HbsAg, and antibody to HCV.  These tests must be negative 
for eligibility into the study. In cases where a false positive result is suspected, confirmatory 
testing may be performed (e.g., Polymerase Chain Reaction).   
Subjects will be screened for SARS-CoV-2 antibodies as well as a reverse transcriptase 
polymerase chain reaction test for SARS-Co-V-2. These tests must be negative for eligibility into 
the study. 
7.5.1.2. 
  Drug Screen 
A urine toxicology screen will be performed to detect for the presence of the following: cocaine 
(and metabolite), barbiturates, benzodiazepines, opiates, THC, methamphetamine/amphetamine, 
methadone and PCP. The results must be negative for eligibility into the study.  A breathalyzer 
test or blood/saliva alcohol test will also be performed, and results must be negative for 
eligibility into the study. 
7.5.1.3. 
 Pregnancy Testing 
For women of child-bearing potential, a serum pregnancy test will be done at screening and must 
be negative.  A urine pregnancy test will be done at Visit 2 (Day 1), which must be reported as 
negative before dosing. A urine pregnancy test will be repeated on Day 4, Day 45, Day 120, 150, 
Day 180, and 365.  
7.5.1.4. 
 Screening Laboratory Tests 
The following laboratory tests will be performed at screening: 
• Hematology: hemoglobin, WBC with differential, absolute neutrophil count and 
platelet count. MCV, MCH, MCHC, RDW, MPV, which are included in a complete 
blood count with differential, will not be graded. 


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• Chemistry:  serum creatinine, BUN, calcium, total bilirubin, direct bilirubin, indirect 
bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, and 
total CK.  
• Urinalysis: dipstick: Urine protein, blood and glucose must be negative or trace. 
Menstruating females failing with a positive blood on urine dipstick may be retested 
following cessation of menses.  If dipstick is abnormal, a complete urinalysis with 
microscopic will be performed.  When a urine dipstick is more than trace positive for 
blood (whether a menstruating female or other subject), that subject would not be 
excluded if the urine microscopic exam shows <5 RBC/HPF.  
• FSH to confirm post-menopausal status for women ≥ 1 year without menses 
Laboratory values that are outside the range of eligibility but are thought to be due to an acute 
condition or due to laboratory error may be repeated once.   Laboratory values will be entered in 
the Clinical Labs Ecrf. 
7.5.2. 
 Safety Laboratory Tests 
The following laboratory tests will be performed at Days 8, 15, 30, 90, 180, and 365.   
Safety labs with a mild Grade 1 value will not exclude a subject from participation but will serve 
as their baseline value.   
• Hematology: hemoglobin, WBC with differential, absolute neutrophil count and 
platelet count. MCV, MCH, MCHC, RDW, MPV, which are included in a complete 
blood count with differential, will not be graded. 
• Chemistry:  serum creatinine, BUN, calcium, total bilirubin, direct bilirubin, indirect 
bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, and 
total CK.  
• Urinalysis: dipstick: Urine protein, blood and glucose must be negative or trace. 
Menstruating females failing with positive blood on urine dipstick may be retested 
following cessation of menses. 
7.5.3. 
Hypersensitivity Panel 
A hypersensitivity panel includes cytokine and complement panels, IgE and tryptase. This 14 mL 
sample will be drawn on Day 1 prior to dosing. The sample will be processed only if the subject 
has a hypersensitivity reaction. If a subject develops anaphylaxis or anaphylactoid reaction, an 
additional 10 mL sample will be drawn during the event and another will be drawn after the 
event.  Refer to the Manual of Procedures for further details. 


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7.6. 
Special Assays or Procedures 
7.6.1. 
  Pharmacokinetic Assay 
Six-mL of blood will be drawn for the analysis of levels of monoclonal antibodies in serum using 
a validated ELISA.  For each timepoint, aliquot at least 0.50 mL each of serum into three 1.8 mL 
sterile cryogenic vials, freeze and store serum samples at ≤ -70°C until shipment. 
PK samples will be tested by ELISA at pre-dose, 2, 4, 8, and 24 hours post dose and on Days 3, 
4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365. 
7.6.2. 
Microneutralization Assay 
Three ten-mL samples of blood will be drawn to be analyzed for neutralizing antibody 
concentration using the validated Battelle microneutralization assay.  For each timepoint, aliquot 
2.5 mL each of serum into six sterile cryogenic vials, freeze and store serum samples at ≤ -70°C 
until shipment. 
Samples will be tested by Microneutralization at pre-dose and Days 2, 15, 30, 60, 90, 120, 150, 
and Day 180 for all cohorts. 
7.6.3. 
 Immunogenicity / Anti-Drug Antibody Assay 
Six-mL samples of blood will be drawn at pre-dose and on Days 15, 30,45,60, 90, 120, 150, 180, 
and 365 for determining the presence of ADA using validated ECLA methods that detect anti-
mAb2130 and anti-mAb2381 antibodies in serum.   This will be done to assess immunogenicity.  
For each timepoint, aliquot at least 0.50 mL each of serum into three 1.8 mL sterile cryogenic 
vials, freeze and store serum samples at ≤ -70°C until shipment 
7.6.4. 
 RT-PCR Testing for SARS-CoV-2  
A nasopharyngeal swab specimen will be collected for RT-PCR testing for SARS-CoV-2 at 
screening and upon presentation of COVID-19 symptoms.  If a subject acquires COVID-19 
during their participation in the study, they should seek and obtain the appropriate treatment.   
7.6.5. 
Future Use  
Five-mL samples of blood will be drawn for subjects who consent to have samples stored for 
future use.  These samples will be collected at Days 1, 2, 8 and 30.  For each timepoint, aliquot at 
least 0.25mL each of serum into two (2) 1.8mL sterile cryogenic vials, freeze and store serum 
samples at ≤ -70°C until shipment. 
This blood sample may be used in new or different laboratory tests, to provide information for 
the development of new drug products, or for the studies of SARS-Co-V-2 or other infections. 
7.6.6. 
Specimen Preparation, Handling, and Shipping 
Details regarding the specimen preparation, handling, storage, and shipping are described in the 
MOP. 
 
 


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Table 2: 
Laboratory Samples and Estimated Total Blood Volume (mL)  
Study Visit 
 
Screen 
01 
Baseline/
Dose 
02 
Dischar
ge 
03 
 
04 
 
05 
 
06 
 
07 
 
08 
 
09 
 
10 
 
11 
 
12 
 
13 
 
14 
Last 
outpatient 
visit 
15 
 
 
Total 
Study Day 
-14 to 
-2 
1 
 
2 
 
3 
 
4 
 
8 
±2 
15 
±2 
30 
±2 
45 
±3 
60 
±3 
90 
±3 
120 
±3 
150 
±3 
180 
±3 
365 
±3 
 
Dosing 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV, 
HBV,HCV 
Serum β-
HCG 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
Screening 
Labs 
 
9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
Safety Labs 
 
 
 
 
 
9 
9 
9 
 
 
9 
 
 
9 
9 
54 
PK 
 
 
24a 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
102 
MN 
 
30 
30 
 
 
 
30 
30 
 
30 
30 
30 
30 
30 
 
270 
SARS-CoV-
2 antibodies 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
ADA 
 
6 
 
 
 
 
6 
6 
6 
6 
6 
6 
6 
6 
6 
60 
Future Usec 
 
 
10 
5 
 
 
 
5 
 
5 
 
 
 
 
 
 
 
25 
Hypersen-
sitivity panel 
 
 
 
14b 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14 
 
Total 
Volume/ 
Visit 
 
15 
84 
41 
6 
6 
20 
51 
56 
12 
42 
51 
42 
42 
 
51 
 
21 
540 
 
Cumulative 
Totald 
 
15 
99 
140 
146 
152 
172 
223 
279 
291 
333 
384 
426 
468 
519 
540 
 
a PK serum samples taken prior to injection and 2hr, 4hr, 8hr 
b If a subject develops anaphylaxis or anaphylactoid reaction, an additional 14mL will be drawn during the event and after the 
event.  In this instance an additional 30 mL may be drawn from a subject than is reflected in the table totals. 
c For subjects consenting to future use 
d Total estimated volume drawn will vary slightly depending on future use consent and need for additional draws for the 
occurrence of hypersensitivity  


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8. 
STUDY SCHEDULE 
The Schedule of Events is included as Appendix A. 
8.1. 
Visit 1: Screening (Day -14 to Day -2) 
After providing written informed consent, each subject will be assigned a Subject ID number 
(840-XXX-XXX) and undergo an eligibility assessment.  The following will be done during the 
screening period (within 14 days prior to administration of study product).  Results of screening 
tests and procedures will be evaluated by the investigator to determine eligibility prior to 
enrollment and randomization.  The following procedures will be performed. 
• Record demographics including age, gender, race and ethnicity.  Obtain contact 
information. 
• Obtain medical history.  The medical history will include the following: 
− current medical diagnoses 
− past medical diagnoses 
− hospitalizations 
− major surgical procedures  
− blood transfusions or immunoglobulin within the last 6 months 
− live vaccines within the last 28 days 
− killed vaccines within the last 28 days 
− blood or plasma donation within the last 56 days 
− allergic reactions 
− drug and/or alcohol use disorder or dependence 
− receipt of investigational drug within the last 28 days 
− Receipt of monoclonal antibody in the past  
• Documentation that the subject has not received an FDA approved vaccine for 
COVID-19 (Subjects may receive an approved COVID-19 vaccine after completing 
their Day 90 visit). For Cohort 5, subjects who received a COVID-19 vaccine within 
14 days prior to enrollment are excluded. 
• Review concomitant medication history, including all medications taken within the 
last 28 days 
• Review current use of contraceptive methods and recent menstrual history (female 
subjects only) 


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• Perform abbreviated PE by licensed clinician listed on the Form FDA 1572 [examples 
include Medical Doctor, Nurse Practitioner and Physician’s Assistant] 
• Obtain height and weight and calculate BMI  
• Take vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and 
oral temperature)  
• Obtain fasting blood samples for viral serology, clinical laboratory screening tests 
including SARS-CoV-2 antibodies and RT-PCR for SARS-Co-V-2 
• Obtain blood sample for serum pregnancy test for women of childbearing potential 
• Obtain urine sample for dipstick urinalysis and urine toxicology 
• Obtain 12-lead ECG 
• Perform Breathalyzer test or blood/saliva alcohol test for recent alcohol use 
• Counsel both men and women of childbearing potential on the avoidance of 
pregnancy  
• Distribute fact sheet from the Centers for Disease Control website “How to Protect 
Yourself & Others” (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-
sick/prevention.html) and review its content with the subject 
• If screening occurs during influenza season, encourage subject to obtain licensed 
(nonliving) influenza vaccine at least 14 days prior to scheduled dosing or after Day 
60 on study. Of note, the subject is not prohibited from receiving an influenza vaccine 
while on study, however the above restrictions are highly encouraged.   
 
8.2. 
Visit 2: Baseline / Day of Dosing (Day 1) 
Subjects meeting inclusion/exclusion criteria will be admitted to the clinical unit the day of 
injection and the following procedures will be performed prior to the study drug administration: 
Prior to Dosing 
• Review inclusion/exclusion to confirm eligibility  
• Review CDC fact sheet on prevention of COVID-19 with subject 
• Review and update concomitant medications and medical history 
• Obtain vital signs  
• Perform abbreviated physical examination with focused assessment for the presence 
of the following in order to detect signs of a hypersensitivity reaction: 
− General appearance including alertness, diaphoresis, chills, and any difficulty 
breathing.   


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− HEENT (confirm no swelling of lips/tongue/uvula) 
− Chest (confirm no stridor or wheezing) 
− Heart (assess regularity of rhythm) 
− Skin (confirm no hives, examine for any eruptions) 
− Joints (confirm no swelling, warmth, or tenderness) 
• Perform Breathalyzer test or blood/saliva alcohol test to detect recent alcohol use 
• Obtain urine sample for toxicology 
• For women, a urine Hcg test will be done.  The results must be confirmed to be 
negative before dosing 
• Obtain blood samples for baseline serum PK and future use (for subjects who 
consent)  
• Obtain blood sample for ADA 
• Obtain blood sample for MN 
• Obtain blood sample for RT-PCR testing  
• Obtain blood sample for hypersensitivity panel 
• Randomize the subject  
• Obtain study product from the pharmacy 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
During Dosing 
• Study product should be injected into the gluteus medius (see Appendix C).  First 
divide the buttock in half from top to bottom and then in half from side to side.  The 
injection should be given in the upper outer quarter. 
• A study physician should be present at the time of study drug administration and the 
subject will be under direct observation during at least the initial 30 minutes after the 
injection by clinical study staff.  The study staff should observe the subject closely for 
signs and symptoms of anaphylaxis and anaphylactoid type reactions.  Should an 
adverse reaction of this type occur, the subject will be treated using the standard 
protocol at the site   
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
15 (±3) minutes after the injection is completed.   
• Perform an abbreviated PE at 30 (±5) minutes post injection or in response to subject 
symptoms focusing on signs of anaphylaxis as follows: 


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− General appearance including alertness, diaphoresis, chills, and any difficulty 
breathing.   
− HEENT (confirm no swelling of lips/tongue/uvula) 
− Chest (confirm no stridor or wheezing) 
− Heart (assess regularity of rhythm) 
− Skin (confirm no hives, examine for any eruptions) 
− Joints (confirm no swelling, warmth, or tenderness) 
• Assessment of Aes and SAEs  
Post Dosing 
• Obtain vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, 
and oral temperature)  every hour (±10 min) for the first 2 hours after the completion 
of the injection and then every 2 hours (±10 min) for the next 4 hours.  More frequent 
monitoring will be at the discretion of the PI based on the clinical presentation of the 
subject. 
• Obtain blood samples for PK measurements at 2 h (±10 min), 4 h (±15 min), 8 h (±15 
min) post injection.   
• Obtain serum samples for future use (if consent given) at the following times after the 
end of injection, 2 h (±15 min), and 4 h (±15 min). 
• Obtain a 12-lead ECG 30 minutes (±10 minutes) after completion of the injection. 
• Assessment of Aes and SAEs  
8.3. 
Visit 3: Discharge from Unit (Day 2) 
The subject is eligible for discharge 24 hours after the IM dosing is complete and after the 
following assessments have been performed and no signs of anaphylaxis have developed: 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform a symptom directed PE  
• Obtain blood samples for the following: 
− PK measurement at 24 hours (± 2 hours) 
− MN  
− Serum sample to store for future use (if subject gave consent) 
• Assessment of Aes and SAEs 


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• Remind the subject not to receive any drugs listed in section 6.8 for the duration of 
the study unless clinically indicated.   If subjects receive necessary vaccines that are 
clinically indicated (e.g. tetanus after an open wound injury, influenza), they will be 
instructed to contact study staff immediately. Subjects may receive an approved 
COVID-19 vaccine after completing their Day 90 visit 
• Counsel both men and women of childbearing potential on the avoidance of 
pregnancy 
• Counsel all subjects on prevention of COVID-19 
• Discharge subject and instruct on the next scheduled visit 
8.4. 
Visit 4: Out-patient Follow-up (Day 3) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for PK at 48 hours (± 2 hours) post dosing completion 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
• Counsel all subjects on prevention of COVID-19 
• Assessment of Aes and SAEs  
8.5. 
Visit 5: Out-patient Follow-up (Day 4) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for PK at 72 hours (± 2 hours) post dosing completion 
• Obtain urine sample urine HCG for women of childbearing potential 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
• Counsel all subjects on prevention of COVID-19 
• Assessment of Aes and SAEs 
8.6. 
Visit 6: Out-patient Follow-up (Day 8± 2) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 


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• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety Labs 
− PK measurement  
− Serum sample to store for future use (if subject gave consent) 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
• Counsel all subjects on prevention of COVID-19 
• Assessment of Aes and SAEs 
8.7. 
Visit 7: Out-patient Follow-up (Day 15± 2) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety Labs 
− PK measurement  
− ADA 
− MN 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.8. 
Visit 8: Out-patient Follow-up (Day 30 ± 2) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety Labs 
− PK measurement  


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− ADA 
− MN 
− Serum sample to store for future use (if subject gave consent) 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.9. 
Visit 9: Out-patient Follow-up (Day 45± 3) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− PK measurement  
− ADA 
• Perform urine pregnancy test on women of child-bearing potential 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.10. 
Visit 10: Out-patient Follow-up (Day 60 ± 3) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− PK measurement  
− ADA 
− MN 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 


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• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.11. 
Visit 11: Out-patient Follow-up (Day 90±3) 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety labs 
− PK measurement  
− ADA 
− MN 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.12. 
Visit 12: Out-patient Follow-Up (Day 120±5)   
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− PK measurement  
− ADA 
− MN 
• Obtain urine sample for dipstick analysis  
• Perform urine pregnancy test on women of child-bearing potential 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 


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8.13. 
Visit 13: Out-patient Follow-Up (Day 150±5)   
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− PK measurement  
− ADA 
− MN 
• Obtain urine sample for dipstick analysis  
• Perform urine pregnancy test on women of child-bearing potential 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.14. 
Visit 14: Out-patient Follow-Up (Day 180±5)   
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety labs 
− PK measurement  
− ADA 
− MN 
• Obtain urine sample for dipstick analysis  
• Perform urine pregnancy test on women of child-bearing potential 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy  
 


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8.15. 
Visit 15: Day 365 ±5 /  Early Termination 
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Review and update concomitant medications 
• Perform symptom directed PE  
• Obtain blood samples for the following: 
− Clinical Safety labs 
− PK measurement  
− ADA 
• Obtain urine sample for dipstick analysis  
• Perform urine pregnancy test on women of child-bearing potential 
• Assessment of Aes and SAEs 
• Counsel all subjects on prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy (for subjects who withdraw from the study early) 
 
8.16. 
Visit 16: Telephone Visit (Day 450 ±5) for Cohorts 1-4 
• Review and update concomitant medications 
• Assessment of Aes and SAEs 
• Counsel all subjects on the prevention of COVID-19 
• Counsel both men and women of child-bearing potential on the avoidance of 
pregnancy 
8.17. 
Visit 17: Telephone Visit (Day 540 ±5) for Cohorts 1-4 
• Review and update concomitant medications 
• Assessment of Aes and SAEs 
• Counsel all subjects on the prevention of COVID-19 
8.18. 
Unscheduled Visit 
A subject may return to the clinic for an unscheduled visit at any time.  The following activities 
at a minimum should be performed:  
• Obtain vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• Perform symptom directed PE as appropriate 


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• Review and update concomitant medications 
• Assessment of Aes and SAEs 
9. 
ASSESSMENT OF SAFETY 
Regulatory requirements including the FDA regulations and ICH Guidelines for GCP set forth 
safety monitoring and reporting responsibilities of sponsors and investigators to ensure the safety 
and protection of human subjects participating in clinical trials.   
Responsibilities 
Investigators participating in this clinical trial are responsible for and will: 
• evaluate subject safety including assessment of Aes for seriousness, severity, and 
causality; 
• notify the sponsor (RGS) of SAEs immediately; 
• provide detailed written reports, including necessary documentation requested by the 
sponsor or IRB/Independent Ethics Committee (IEC), promptly following immediate 
initial reports, and; 
• inform the IRB/IEC of Aes as required by applicable regulatory requirements. 
• have emergency staff and medications such as epinephrine, corticosteroids, 
bronchodilators, and emergency tool kits for emergent intubation and initial acute 
cardiopulmonary resuscitative care are available at all clinical sites in the event they 
are needed during and immediately after IM injections. 
 
9.1. 
Specification of Safety Parameters 
Definitions 
Adverse events 
ICH E6(R2) defines an AE as any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment.  An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of medicinal (investigational) product, whether or not related to the 
medicinal (investigational) product.   
FDA defines an AE as any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. 
Serious Adverse Events 
An SAE is any untoward medical occurrence that at any dose: 
• Results in death, 


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• Is life-threatening*,  
• Requires inpatient hospitalization or prolongation of existing hospitalization, 
• Congenital anomaly/birth defect; 
• Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• Important Medical Event 
*Life-threatening adverse event.  An adverse event is considered “life-threatening” if, 
in the view of either the investigator or sponsor, its occurrence places the patient or 
subject at immediate risk of death.  It does not include an adverse event, had it 
occurred in a more severe form, that might have caused death. 
Unexpected 
An adverse reaction, the nature or severity of which is not consistent with the applicable product 
information (e.g. Investigator’s Brochure for an unapproved investigational product or package 
insert/summary of product characteristics for an approved product). 
9.2. 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
9.2.1. 
Adverse Events 
Adverse events will be collected at Day 1 during and after dosing.  Any medical condition that is 
present at the time that the subject is screened should be considered as baseline and not reported 
as an AE.  However, if the condition increases in severity or frequency at any time during the 
study, it should be recorded as an AE. 
All Aes must be graded for severity and relationship to study product based on the Investigator’s 
assessment. 
Severity of adverse events will be graded using CTCAE v5.0 (Appendix B). 
9.2.2. 
Relationship to Study Product 
Aes and SAEs must be assessed by the investigator to determine relationship to study product.  
All Aes must have their relationship to study product assessed using the following terms.  In a 
clinical trial the study product must always be suspect.   
• Definitely Related:  There is a definite probability that the study product caused the 
adverse event. 
• Possibly Related:  There is a reasonable possibility that the study product caused the 
adverse event.  Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study product and the adverse event 


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• Not Related: There is not a reasonable possibility that the administration of the study 
product caused the event 
To help assess, the following factors may be considered: 
• Temporal relationship of the event to the administration of study product; 
• Whether an alternative etiology has been identified; 
• Biological plausibility; 
• Existing therapy and/or concomitant medications. 
9.3. 
Reporting Procedures 
9.3.1. 
 Adverse Events: 
Aes not meeting the criteria for “SAEs,” will be captured on the appropriate case report form.  
Information to be collected for Aes includes event description, date of onset, investigator 
assessment of severity, relationship to study product, date of resolution of the event, seriousness, 
and outcome. 
All Aes will be followed until resolved or considered stable by the investigator.  
9.3.2. 
Serious Adverse Events 
The following procedures will apply to all serious adverse events: 
• The Principal Investigator will report any SAE to ICON PVSS within 24 hours of 
awareness. 
• ICON PVSS will perform an initial check of the SAE and contact the site for any 
missing elements and then inform the ICON MM, and the ISM of the SAE. 
• ICON PVSS will record the information on the appropriate serious adverse event 
report form and send to RGS 
• Each SAE will be reviewed and followed to resolution or stability by a study 
physician 
• SAEs will be collected on each subject up to 60 days after his/her last study visit. 
Any AE that meets a protocol-defined serious criterion must be submitted immediately 
(within 24 hours of site awareness) on an SAE form to RGS at the following address: 
 
ICON PVSS 
 ICON plc PVSS 
                                                           3rd Floor Marlow International, Parkway, Marlow, 
 
Buckinghamshire, SL7 1YL, United Kingdom 


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SAE Email Address: ICON-Safety-
CentralReceipt@iconplc.com  
                                                                         SAE Fax Number (in case email is not available): 
                                                                                                                                +44 (0) 208-100-5005 
 
ICON PVSS will send AE/SAE information to Resilience Government Services, Inc. 
Resilience Government Services 
Resilience Government Services, Inc. 
 
13200 NW Nano Court  
 
Alachua, FL 32615, USA 
 
 SAE Hotline: 240-885-1221  
 
SAE Fax Number:  888-551-1691 
 
SAE Email Address: olo.safety@resilience.com  
 
Other supporting documentation of the event may be requested by RGS and should be provided 
as soon as possible.  
ICON plc PVSS will send SAEs with the ICON Drug Safety Physician assessment of causality, 
expectedness, and any impact on the benefit-risk ratio of the IMP to RGS.  The DOD will be 
notified of the SAE by RGS.   
If the investigator becomes aware of an SAE that is suspected to be related to study product up to 
60 days after the subject completes the study, the investigator will report the event to ICON 
PVSS. 
9.3.3. 
Regulatory Reporting  
Following notification from the investigator, RGS, the IND sponsor, will report any suspected 
adverse reaction that is both serious and unexpected to the FDA.  RGS will report an adverse 
event as a suspected adverse reaction only if there is evidence to suggest a causal relationship 
between the drug and the AE.  RGS will notify FDA and all participating investigators (i.e., all 
investigators to whom the sponsor is providing drug under its INDs or under any investigator’s 
IND) in an IND safety report of potential serious risks from clinical trials or any other source, as 
soon as possible, but in no case later than 15 calendar days after the sponsor determines that the 
information qualifies for reporting as specified in 21 CFR Part 312.32. RGS will also notify FDA 
of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in 
no case later than 7 calendar days after the sponsor’s initial receipt of the information. Relevant 
follow up information to an IND safety report will be submitted as soon as the information is 
available.  Upon request from FDA, RGS will submit to FDA any additional data or information 
that the agency deems necessary, as soon as possible, but in no case later than 15 calendar days 
after receiving the request. 


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All SAEs designated as “not related” to study product(s), will be reported to the FDA at least 
annually in a summary format. 
9.3.4. 
 Reporting of Pregnancy 
Pregnancies that occur during the study period will be reported to the Sponsor on the Pregnancy 
Report form within five days of site awareness. 
Efforts will be made to follow all pregnancies occurring prior to 56 days post product 
administration through to outcome, as described in the Safety Management Plan (e.g. delivery, 
spontaneous abortion or therapeutic abortion). 
9.4. 
Type and Duration of Follow-up of Subjects after Adverse Events 
AEs will be followed until resolution or stability even if this extends beyond the study-reporting 
period.  Resolution of an AE is defined as the return to pretreatment status or stabilization of the 
condition with the expectation that it will remain chronic. 
Follow-up procedures, evaluations, and outcomes will be recorded on the subject's case report 
forms. 
Subjects who experience AEs consistent with COVID-19 through Day 540 for cohorts 1-4 and 
Day 365 for cohort 5 will be evaluated either by the site or by a health care provider to which the 
subject may be referred. Clinical specimens for SARS-CoV-2 RNA and serum for immunology 
(e.g., pro-inflammatory cytokine levels) assessments will be collected or requested to be 
collected using standardized methods. Assays of these specimens will be conducted at a central 
laboratory. Subjects will ideally be followed for as long as they continue to shed viral RNA. If 
feasible, other samples for concurrent or retrospective virologic assessments (e.g., the 
quantification of viral RNA in blood, rectal swabs, lower respiratory tract samples) will also be 
collected and analyzed. 
9.5. 
Halting Rules 
9.5.1. 
Halting Criteria for the Study 
Study dosing can be halted at any time if medically indicated.  Study dosing must be stopped, 
and a review of available safety data will be conducted by the SRC if any of the following occur: 
1. Death of a dosed subject following injection and prior to the subject’s last visit that was 
not the result of trauma or accident, and possibly related to study product. 
2. Occurrence of a life-threatening allergic/hypersensitivity reaction (anaphylaxis) in any 
subject, manifested by bronchospasm with or without urticaria or angioedema or 
requiring hemodynamic support with pressor medications or mechanical ventilation.  
3. One subject with an SAE that is considered possibly related or definitely related to study 
product. 
4. Two or more subjects with a Grade 3 AE in the same organ class (systemic toxicity, 
clinical laboratory tests or vital signs) regardless of relatedness to study drug.  An 


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exception to this includes scenarios where there are obvious and acceptable physiological 
explanations for a Grade 3 abnormality (e.g., Grade 3 hematuria in a menstruating 
female). 
9.5.2. 
Dose Escalation Halting Criteria 
If any of the following criteria are met, escalation to the next planned dose cohort will not 
proceed until all available study data have been reviewed by the SRC.  
• More than 25% of the subjects in the cohort experience an AE, grade 2 or above in 
the same organ class 
• A specific AE increases in severity from one cohort to the next AND the number of 
subjects reporting that AE (at the higher severity level) in the cohort is the same or 
greater. An exception would be headaches going from a grade 1 to a grade 2. 
9.5.3. 
Evaluation of Dose Escalation 
The SRC must agree unanimously on the following criteria prior to dose escalation: 
• A review of all available unmonitored and uncoded safety data from at least 7 
subjects per cohort to Day 8, at a minimum, demonstrate that study halting criteria as 
outlined in Section 9.5.2 have not been met. 
• A review of all available unmonitored and uncoded safety data from at least 7 
subjects per cohort to Day 8, at a minimum, demonstrate that no safety signals of any 
nature were observed. 
9.6. 
Safety Oversight  
9.6.1. 
Independent Safety Monitor (ISM) 
The ISM is a physician with relevant expertise whose primary responsibility is to provide 
independent safety monitoring in a timely fashion.  The ISM will review SAEs and other AEs as 
needed and provide an independent assessment.   
9.6.2. 
ICON Medical Monitor 
The ICON Medical Monitor (MM) is the clinical site’s primary point of contact for eligibility or 
safety related questions.  The ICON MM is responsible for liaising with RGS ML to ensure that 
all medical concerns are communicated and will provide any potential pertinent medical 
communication update to the project team as needed.  The ICON MM will participate in the 
planned SRC meetings and can make a recommendation that the SRC be convened to review any 
safety concerns.  
9.6.3. 
Resilience Government Services Medical Lead  
The RGS ML will be the main point of contact for the ICON MM and the DOD for any safety-
related questions or concerns.  The RGS ML will escalate any medical or safety concerns to the 
DOD as needed. The RGS ML will participate in the planned SRC meetings and can make a 
recommendation that the SRC be convened to review any safety concerns.  


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9.6.4. 
Safety Review Committee (SRC) 
The SRC will be composed of:  
• PI, or designee  
• RGS ML  
• ICON Medical Monitor or designee; 
Objective dose-escalation criteria and safety evaluations will be utilized.  Prior to dose 
escalation, the SRC will evaluate unmonitored and uncoded safety and tolerability data for at 
least 7 subjects out to Day 8 to determine whether dose escalation can occur.  If none of the 
events described in 9.5.1 Study Halting Criteria or in 9.5.2 Dose Escalation Halting Criteria are 
observed, dose escalation will proceed.  Should any of the study halting criteria or dose 
escalation halting criteria be met, the SRC will meet to evaluate the data and recommend 
appropriateness of further dosing.  The SRC recommendation to advance to the next level will be 
documented and provided to all the appropriate parties (PI, RGS, and ICON) involved with the 
study. 
If 4 or more subjects withdraw prior to Day 8, those subjects need to be replaced to ensure that 
data for at least 7 subjects are available for review. 
If 4 or more subjects withdraw prior to Day 60 or are not compliant with all PK draws through 
Day 15, they may be replaced.   
If more than 2 subjects withdraw following the Day 8 SRC review of safety data, the site will 
attempt to replace those subjects in that dose group at the time of the next planned cohort. 
10. 
CLINICAL MONITORING 
10.1. 
Site Monitoring Plan 
Site monitoring is conducted to ensure that the human subject protection, study and laboratory 
procedures, study intervention administration, and data collection processes are of high quality 
and meet sponsor, GCP/ICH and, when appropriate, regulatory guidelines.  Site visits may be 
conducted by an authorized representative of ICON, the IRB, HRPO, other regulatory or 
government agencies to inspect study data, subjects’ medical records, and eCRFs in accordance 
with ICH guidelines, GCP and the respective local and national government regulations and 
guidelines. 
The investigator will permit authorized representatives of ICON and the respective local and 
national health authorities to inspect facilities and records relevant to this study, if needed. 
A separate monitoring plan, to be developed by ICON, will describe protocol-specific items to be 
monitored. 


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11. 
STATISTICAL CONSIDERATIONS 
11.1. 
Sample Size Considerations 
This is a Phase 1 study first in humans with five dosing cohorts and no formal sample size 
calculations based on testing a statistical hypothesis were constructed. Sample sizes are 
consistent with this type of early phase study. Dosing groups of ten participants each, eight 
participants assigned the active group and two assigned to the control group for each cohort are 
practical and provide sufficient information for a total sample size of 50 for a Phase 1 trial 
primarily designed to assess safety. 
The dosing groups of eight participants in the active group has a probability of at least one 
subject experiencing an event of toxicity ranges from 0.728 to 0.996 assuming true event rates 
are between 0.15 and 0.5.  
Additionally, if no events are observed in each scenario described above, the upper bound of an 
exact 95% confidence interval for the true proportion is 0.369.   
 
11.2. 
Planned Interim Analyses  
There are several blinded interim analyses planned for this study.  A blinded interim analysis is 
planned to analyze all PK samples through Day 30 for all subjects in Cohorts 1 and 2.  A second 
blinded interim analysis is planned to analyze all PK samples after all subjects in cohorts 1-3 
complete Day 60. A third interim analysis is planned to analyze safety and PK data after all 
subjects in cohort 5 complete Day 60. 
 
There is also an interim clinical study report (CSR) planned after subjects in Cohorts 1 through 4 
complete Day 90. 
Stopping criteria are for safety and are defined in section 9.5. No adjustments for multiplicity 
will be made at these interim analyses. 
11.3. 
Final Analysis Plan 
A formal statistical analysis plan will be developed with mock tables, listings, and figures. The 
ICH Guidance Document E9 (Statistical Principles for Clinical Trials) will be followed for all 
statistical content.  For categorical data, summaries of frequencies and percentages will be 
presented.  Summaries for continuous data will include minimum, lower quartile, median, mean, 
standard deviation, upper quartile, and maximum. 
11.3.1. 
Analysis Populations 
An intent-to-treat population will consist of all subjects randomized and will be analyzed as 
randomized All subjects who received study product will be included in the safety population 
and analyzed as treated. The PK analysis population will consist of all subjects who complete 


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ADM03820 injection and have sufficient evaluable PK samples for the estimation of PK 
parameters. 
11.3.2. 
Demographics and Baseline Characteristics 
Subject demographics and baseline characteristics will be summarized by dose cohort and 
control group.   
11.3.3. 
 Safety Analysis Plan 
11.3.3.1. Adverse and Serious Adverse Events 
AEs will be coded using Medical Dictionary for Regulatory Activities® (MedDRA). All AEs that 
occur after the initiation of study medication will be summarized using frequency counts and 
percentages. Summaries will be presented by dose cohort and control group. The following 
summaries will be presented for AEs and SAEs:  
• Overall (i.e., regardless of severity or relationship to treatment) 
• By CTCAE v5.0 
• By relationship to study medication 
• By MedDRA level hierarchy (system organ class and preferred term) 
Unless otherwise specified, at each level of subject summarization in reporting the incidence of 
the AEs, a subject will be counted once if the subject reported one or more events. If more than 
one occurrence of an event is reported, the event of the worst severity or the worst-case 
relationship assessment will be summarized.  
11.3.3.2. Additional Safety Analyses 
Vital signs, physical examinations, and clinical laboratory values, including change from 
baseline, will be summarized by dose cohort and control group. 
Descriptive summary statistics for laboratory data at admission (baseline value) and each 
applicable post-dose visit, including change from the baseline value, will be calculated. 
Descriptive summary statistics for vital signs at screening (baseline value) and each applicable 
post-dose visit, including change from the baseline value, will be calculated. Shift tables, 
showing individual subject changes from baseline will be presented for laboratory parameters 
using toxicity grading. Subjects with Graded values of vital sign and laboratory parameters will 
be identified in listings.  
11.3.4. 
  PK Analysis Plan 
PK parameters will be estimated for total antibodies of ADM03820 as measured by enzyme-
linked immunosorbent assay (ELISA) for samples from Cohorts 1 and 2. PK parameters for each 
of the monoclonal antibodies  of ADM03820 as measured by enzyme-linked immunosorbent 
assay (ELISA) for samples from Cohort 3 and 4 using noncompartmental methods in WinNonlin 
or a similar software package. Parameters will be estimated by dose cohort. Summary statistics 


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will include the mean, median, coefficient of variation, and range. When evaluable, estimated PK 
parameters will include: 
• AUC(0-t): Area under the concentration time-curve to the last concentration above the 
lower limit of quantitation 
• Cmax: Maximum observed concentration 
• Tmax: Time of maximum observed concentration 
• Kel: Elimination rate constant 
• AUC(0-∞): Area under the concentration time-curve extrapolated to infinity 
• t1/2: Terminal elimination half-life 
• CL: Total clearance 
• Vz: Volume of distribution 
Additionally, multi-compartmental models will be considered based on inspection of 
concentration-time curves. If models are fit, base models will assume first-order elimination 
from the central compartment, and models will be parameterized in terms of clearance, volume 
of distribution and inter-compartmental rates. Standard objective goodness of fit measures will 
be used to determine the final model. 
11.3.5. 
Immunogenicity 
Immunogenicity will be measured by the development of antibody titers.  The presence of ADA 
will be measured over the course of the post-injection period. 
11.3.6. 
 Missing values and outliers 
All attempts will be made to collect all data per protocol.  No imputation will be performed for 
missing values. Outliers identified during the PK analysis will be discussed in the analysis report. 


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12. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS 
The site will maintain appropriate medical and research records for this trial, in compliance with 
ICH E6(R2) GCP, Section 4.9, and regulatory and institutional requirements for the protection of 
confidentiality of subjects.  As part of participating in a DOD-affiliated, or manufacturer-
sponsored study, the site will permit authorized representatives of the sponsor(s), DOD, and 
regulatory agencies to review (and, when required by applicable law, to copy) clinical records for 
the purposes of quality assurance reviews, audits, and evaluation of the study safety and 
progress. 
Forms for use as source documents will be derived from the electronic CRFs and will be 
provided by ICON.  Additional source data are all information, original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the reconstruction and 
evaluation of the trial.  Examples of these original documents and data records include, but are 
not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, and subject files and records kept at the pharmacy, 
laboratories, and medico-technical departments involved in the clinical trial.  If data is recorded 
directly into the eCRF with no paper source, then that data should be listed as being a direct 
electronic data entry with no paper source available. 
13. 
QUALITY CONTROL AND QUALITY ASSURANCE 
Following a written DOD-accepted site quality management plan, the investigational site is 
responsible for conducting routine quality assurance and quality control activities to internally 
monitor study progress and protocol compliance.  The PI will provide direct access to all trial-
related sites, source data/documents, and reports for the purpose of monitoring and auditing by 
the sponsor, and inspection by local and regulatory authorities. The PI will ensure all study 
personnel are appropriately trained and applicable documentations are maintained on site.  
Clinical monitors will verify that the clinical trial is conducted, and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable 
regulatory requirements.  Clinical monitoring reports will be submitted to RGS. 
ICON will implement quality control procedures beginning with the data entry system and 
generate data quality control checks that will be run on the database. Any missing data or data 
anomalies will be communicated to the site(s) for clarification and resolution. 
 
14. 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
14.1. 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with principles of the 
Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of 


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Research of the National Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research (April 18, 1979) and codified in 45 CFR 46, 21 CFR 50 and 56, and ICH 
E6(R2); 62 Federal Regulations 25691 (1997), if applicable.  The investigator’s Institution will 
hold a current Federal Wide Assurance (FWA) issued by the Office of Human Research 
Protection for federally funded research. 
14.2. 
Institutional Review Board 
ICON will provide for the review and approval of this protocol and the associated informed 
consent documents, by an appropriate ethics review committee or IRB listed on the FWA.  Any 
amendments to the protocol or consent materials must also be approved before they are placed 
into use unless change is for the safety of the subject.  Only those IRB members who are 
independent of the investigators and the sponsor should provide an opinion on study related 
matters.  Verification of IRB approval of the protocol and the written informed consent will be 
transmitted by the investigator or designee prior to the shipment of study product.  No deviations 
from or changes to the protocol will be initiated without prior approval of an appropriate 
amendment unless change is for the safety of the subject. 
14.3. 
Informed Consent Process 
14.3.1. 
  Informed Consent 
The written consent document will embody the elements of informed consent as described in the 
Declaration of Helsinki and will adhere to the ICH Harmonized Tripartite Guideline for Good 
Clinical Practice.  Informed consent should be implemented before any protocol-specified 
procedures or interventions are carried out.  Informed consent will be obtained in accordance 
with 21 CFR 50.25 and 45 CFR 46.  Information should be presented both orally and in written 
form. 
An investigator or designee will describe the protocol to potential subjects face-to-face.  The 
investigator shall give the subjects ample opportunity to read the Subject Information and 
Consent Form and to inquire about details of the study and ask any questions before the signing 
and dating the consent form. 
Study staff must inform subjects that the trial involves research, and explain the purpose of the 
trial, those aspects of the trial that are experimental, any expected benefits, all possible risks 
(including a statement that the particular treatment or procedure may involve risks to the subject 
or to the embryo or fetus, if the subject is or may become pregnant, that are currently 
unforeseeable), the expected duration of the subject’s participation in the trial, the procedures of 
the research study, including all invasive procedures, and the probability for random assignment 
to treatment groups.  Subjects will be informed that they will be notified in a timely manner if 
information becomes available that may be relevant to their willingness to continue participation 
in the trial.  They must also be informed of alternative procedures that may be available, and the 
important potential benefits and risks of these available alternative procedures.  Subjects must 
receive an explanation as to whether any compensation and any medical treatments are available 
if injury occurs, and, if so, what they consist of, or where further information may be obtained.  


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Subjects must be informed of the anticipated financial expenses, if any, to the subject for 
participating in the trial, as well as any anticipated prorated payments, if any, to the subject for 
participating in the trial.  They must be informed of whom to contact (e.g., the investigator) for 
answers to any questions relating to the research project.  Information will also include the 
foreseeable circumstances and/or reasons under which the subject’s participation in the trial may 
be terminated.  The subjects must be informed that participation is voluntary and that they are 
free to withdraw from the study for any reason at any time without penalty or loss of benefits to 
which the subject is otherwise entitled. 
Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to 
participate or continue to participate in the trial.  The extent of the confidentiality of the subjects’ 
records must be defined, and subjects must be informed that applicable data protection 
legislation will be followed.  Subjects must be informed that the monitor(s), auditors(s), IRB, 
DOD, RGS, and regulatory authority(ies) will be granted direct access to the subject’s original 
medical records for verification of clinical trial procedures and/or data without violating the 
confidentiality of the subject, to the extent permitted by the applicable laws and regulations, and 
that, by signing a written informed consent form, the subject is authorizing such access.  Subjects 
must be informed that records identifying the subject will be kept confidential, and, to the extent 
permitted by the applicable laws and/or regulations, will not be made publicly available and, if 
the results of the trial are published, the subject’s identity will remain confidential. 
Consent forms must be in a language fully comprehensible to the prospective subjects.  Informed 
consent shall be documented by the use of a written consent form approved by the IRB and 
signed and dated by the subject and the person who conducted the informed consent discussion.  
The signature confirms that the consent is based on information that has been provided and all 
questions have been answered to the prospective participant’s satisfaction.  Each subject’s signed 
informed consent form must be kept on file by the investigator for possible inspection by 
Regulatory Authorities and/or the sponsor and Regulatory Compliance persons.  The subject 
should receive a copy of the signed and dated written informed consent form and any other 
written information provided to the subjects and should receive copies of any signed and dated 
consent form updates and any amendments to the written information provided to subjects. 
14.4. 
Exclusion of Women, Minorities, and Children (Special Populations) 
Pregnant women, lactating women and children are excluded for safety reasons. 
14.5. 
Subject Confidentiality 
Subject confidentiality is held strictly in trust by the participating investigators, their staff, and 
the sponsor and their agents.  This confidentiality is extended to cover testing of biological 
samples in addition to the clinical information relating to participating subjects. 
The study protocol, documentation, data, and all other information generated will be held in 
strict confidence.  No information concerning the study, or the data will be released to any 
unauthorized third party without prior written approval from the sponsor. 


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The study monitor or other authorized representatives of the sponsor may inspect all documents 
and records required to be maintained by the Investigator, including, but not limited to, medical 
records (office, clinic, or hospital) and pharmacy records for the subjects in this study.  The 
clinical study site will permit access to such records. 
14.6. 
Study Discontinuation 
RGS has the right to terminate this study or the site’s participation at any time.  Reasons for 
terminating the study may include, but are not limited to, the following: 
• Incidence or severity of adverse events indicates a potential health hazard; 
• Data recording is inaccurate or incomplete; 
• Investigator does not adhere to the protocol or applicable regulatory guidelines in 
conducting the study. 
14.7. 
Future Use of Stored Specimens 
Samples will be collected as outlined in the protocol.  Subjects will be given a choice during the 
informed consent process to have their residual linked samples stored indefinitely by the Sponsor 
for future research, have their residual samples de-linked from any subject information and 
stored indefinitely, or have their residual linked samples destroyed at completion of the study.  
The use of long-term stored linked samples will be conducted under the restrictions regarding 
confidentiality, as outlined in the preceding paragraphs. 
Only coded specimens will be sent to the sponsor with the code identifiers maintained by the 
principal investigator.  Any future research studies will utilize only the residual long-term stored 
specimens from subjects consenting to future use.  
15. 
DATA HANDLING AND RECORD KEEPING 
The investigator is responsible to ensure the accuracy, completeness, legibility, and timeliness of 
the data reported.  All data collection forms should be completed in a neat, legible manner to 
ensure accurate interpretation of data.  Black ink is required to ensure clarity of reproduced 
copies.  When making changes or corrections, cross out the original entry with a single line, and 
initial and date the change.  Do not erase, overwrite, or use correction fluid or tape on the 
original. 
Copies of the electronic CRF (eCRF) will be provided to the site to create source documents and 
maintained for recording data for each subject enrolled in the study.  Data reported in the eCRF 
derived from source documents should be consistent with the source documents or the 
discrepancies should be explained. 
RGS and/or its designee will provide guidance to investigators on making corrections to the data 
collection forms/source documents and eCRFs. 


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15.1. 
Data Management Responsibilities 
All source documents and laboratory reports must be reviewed by the clinical team and data 
entry staff, who will ensure that they are accurate and complete.  Adverse Events must be 
graded, assessed for severity and causality, and reviewed by the site Principal Investigator or 
designee. 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site Principal Investigator.  During the study, the investigator must maintain complete and 
accurate documentation for the study. 
ICON will serve as the Statistical and DCC for this study, and will be responsible for data 
management, quality review, analysis, and reporting of the study data. 
15.2. 
Data Capture Methods 
Clinical data (including AEs, concomitant medications, and reactogenicity data) and clinical 
laboratory data will be entered into a 21CFR part 11-compliant Internet Data Entry System 
provided by ICON.  The data system includes password protection and internal quality checks, 
such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate.  Clinical data will be entered directly from the source documents. 
15.3. 
Types of Data 
Data for this study will include clinical safety assessments, safety laboratory assessments, 
immunology, PK, and MNA. 
15.4. 
Timing/Reports 
A final report will be prepared following the availability of all the safety and immunogenicity 
data. 
15.5. 
Study Records Retention 
Study files (except for future use consent forms) must be maintained for a minimum of two years 
after the last approval of a marketing application in an ICH region and until there are no pending 
or contemplated marketing applications in and ICH region or at least 2 years have elapsed since 
the formal discontinuation of clinical development of the investigational product.  These 
documents should be retained for a longer period, however, if required by local regulations. No 
records will be destroyed without the written consent of the sponsor, if applicable.  It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to 
be retained.  Consent forms for future use will be maintained as long as the sample exists. 
15.6. 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or protocol-
specific MOP requirements.  The noncompliance may be either on the part of the subject, the 
investigator, or the study site staff.  As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly. 


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These practices are consistent with ICH E6(R2): 
4.5 Compliance with Protocol, Sections 4.5.1, 4.5.2, and 4.5.3 
5.1  Quality Assurance and Quality Control, Section 5.1.1 
5.20 Noncompliance, Sections 5.20.1, and 5.20.2. 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report 
deviations within five working days of identification of the protocol deviation, or within five 
working days of the scheduled protocol-required activity.  All deviations must be promptly 
reported to ICON and /RGS. 
All protocol deviations, as defined above, must be addressed in study subject source documents 
and entered into a database.  A completed copy of the Protocol Deviation Form must be 
maintained in the Regulatory File per clinical site(s) SOP, as well as in the subject's source 
document.  Protocol deviations must be sent to the local IRB/IEC per their guidelines.  The site 
PI/study staff is responsible for knowing and adhering to their IRB requirements. 
16. 
PUBLICATION POLICY 
All manuscripts resulting from this trial will be reviewed by representatives from the sites, DOD 
and the product manufacturer.  Each institution will have at least thirty days to review the 
publication prior to submission. 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted 
a trials-registration policy as a condition for publication.  This policy requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine (NLM).  Other biomedical journals are considering adopting 
similar policies.  This trial will be registered in NLM in accordance with the new NLM 
requirements under the Food and Drug Administration Amendments Act (FDAAA). 
*Journal Citation : 
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial 
registration: a statement from the International Committee of Medical Journal Editors. N Engl J 
Med. 2004;351:1250-1. 


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APPENDICES


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APPENDIX A: SCHEDULE OF EVENTS 
Study Visit 
Screening1 
 
01 
Baseline/Dosing 
 
02 
Discharge 
 
03 
 
 
04 
 
 
05 
 
 
06 
 
 
07 
 
 
 
08 
 
 
09 
 
 
10 
 
 
11 
 
 
12 
 
 
13 
 
 
14 
Final 
Outpatient
Visit / ET 
15 
 
TC19 
16 
 
TC19 
17 
Study Day (Window) 
-14 to -2 
1 
2 
3 
4 
8±2 
15±2 
30±2 
45±3 
60±3 
90±3 
120±5 
150±5 
180±5 
365±5 
450±
5 
540±5 
Review Inc/ ExcI Criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review Medical History 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review 
Contraception/menses 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Perform Abbreviated PE3 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Perform Symptom-Directed 
PE14 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Vital Signs4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Screening Labs5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Safety Labs,6 
 
 
 
 
 
X 
X 
X 
 
 
X 
 
 
X 
X 
 
 
Serum β-HCG7 
X7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine pregnancy test 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
X 
X 
X 
 
 
Urine Dipstick8  
X 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
Urine Toxicology 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Breathalyzer test 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunogenicity (ADA)15 
 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
PK samples11 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
MN Samples 
 
X 
X 
 
 
 
X 
X 
 
X 
X 
X 
X 
X 
 
 
 
Hypersensitivity Panel16 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG9 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Viral Serology10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Study Visit 
Screening1 
 
01 
Baseline/Dosing 
 
02 
Discharge 
 
03 
 
 
04 
 
 
05 
 
 
06 
 
 
07 
 
 
 
08 
 
 
09 
 
 
10 
 
 
11 
 
 
12 
 
 
13 
 
 
14 
Final 
Outpatient
Visit / ET 
15 
 
TC19 
16 
 
TC19 
17 
Study Day (Window) 
-14 to -2 
1 
2 
3 
4 
8±2 
15±2 
30±2 
45±3 
60±3 
90±3 
120±5 
150±5 
180±5 
365±5 
450±
5 
540±5 
SARS-CoV-2 Antibodies18 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RT-PCR17  
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Future Use Sample12 
 
X 
X 
 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
Counsel on the avoidance of 
pregnancy 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
AE Review  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAE Review 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1. 
Screening will be completed within 14 days prior to administration of study drug and may require more than one visit. 
2. 
Concomitant medications including all of the following: prescription drugs, over-the–counter drugs, herbs, vitamins, nutritional supplements, illicit and recreational substance use, birth control  
3. 
PE includes height and weight at screening.     
4. 
Vital Signs to include sitting diastolic and systolic blood pressure, heart rate, respiratory rate, and oral temperature.  See section 8 for a schedule of when vital signs are to be obtained. 
5. 
Screening Laboratory Tests that will include hemoglobin, WBC with differential, absolute neutrophil count and platelet count. MCV, MCH, MCHC, RDW, MPV, which are included in a complete 
blood count with differential, will not be graded, serum creatinine, BUN, calcium, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, 
and total CK.  Include FSH at screening to confirm post-menopausal status for women ≥ 1 year without menses 
6. 
Clinical Safety Laboratory Tests that will include hemoglobin, WBC with differential, absolute neutrophil count and platelet count. MCV, MCH, MCHC, RDW, MPV, which are included in a complete 
blood count with differential, will not be graded, serum creatinine, BUN, calcium, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, 
and total CK.  
7. 
A serum pregnancy test will be obtained for all women of reproductive capacity.  Results must be confirmed as negative before study product is dosed.   
8. 
A urine dipstick will be done to evaluate for presence of protein, glucose or blood in urine. If dipstick is abnormal, a complete urinalysis with microscopic will be performed. 
9. 
A 12-lead ECG will be performed during screening and post dose performed 30 minutes (±10 minutes) after completion of dosing. 
10. Viral Serology includes HIV, HBsAg and antibody to HCV. 
11. PK samples will be taken at the following times: pre-dose, 2, 4, 8, and 24 hours post injection and on days 2, 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365 for all cohorts 
12. Serum from subjects who give consent for future use samples will be collected at 2 hr and 4 hr post dose and on days 2, 8, and 30 
13. Vital signs (sitting for at least 10 minutes) will be checked just before injection and every visit. 
14. The subject will be under direct observation during at least the initial 30 minutes of  dosing.  A physical examination will be performed at approximately 30 minutes post injection or  in response to 
subject symptoms which will include the following: General appearance including alertness, diaphoresis, chills, and any difficulty breathing, HEENT, Chest, Heart, Skin and Joints 
15.  Draw prior to dosing at baseline 
         16.    The Hypersensitivity Panel includes cytokine and complement panels, IgE, and tryptase.  Draw 14ml prior to dosing. If a subject develops anaphylaxis or anaphylactoid reaction, an additional 10 mL 
sample will be drawn during the event and another will be drawn after the event 


Protocol: ADM03820-001 
                   Version 6.0 
 
July 14, 2022 
 ______________________________________________________________________________________________________  
Resilience Government Services 
134 
Proprietary 
17. 
Subjects in all cohorts will receive RT-PCR testing at screening, Day 1 prior to dosing, and at presentation of symptoms. 
18.  
SARS-CoV-2 antibodies will only be tested in Cohorts 1-4 (Not applicable for Cohort 5).   
19. 
TC visits will be conducted for only Cohorts 1-4 (Not applicable for Cohort 5). 
 


Protocol: ADM03820-001 
                   Version 6.0 
 
July 14, 2022 
 ______________________________________________________________________________________________________  
Resilience Government Services 
135 
Proprietary 
APPENDIX B: CTCAE V5.0 
The CTCAE version 5.0 can be found at the following address: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_60  
 
 
 
 


Protocol: ADM03820-001 
                   Version 6.0 
 
July 14, 2022 
 ______________________________________________________________________________________________________  
Resilience Government Services 
136 
Proprietary 
APPENDIX C: INTRAMUSCULAR (IM) ADMINISTRATION 
Cohorts 1-3 Only: IP is administered as one 3mL (150mg dose) or two 3mL (300mg dose) IM 
injection(s) within 1 hour of thawing. 
Cohort 4 Only: IP is administered as one 3mL (300mg dose) IM injection within 30 minutes of 
removing from refrigerator.  
Cohort 5 Only: IP is administered as two 3mL (600mg dose) IM injection within 30 minutes of 
removing from refrigerator.  
Instruct subject to lay prone (on abdomen) with toes pointing inward and heels apart (to relax 
gluteal muscles). Visually divide the buttock in half from top to bottom and then in half from 
side to side. The injection should be given in the upper outer quarter to avoid the sciatic nerve 
and gluteal artery. Intramuscular (IM) injections are administered into the gluteus medius muscle 
of the buttocks using a 1 ½ inch 20 or 22 gauge needle. Inject entire contents of syringe and 
remove needle. Do not rub the injected area.  Gentle pressure is allowable if bleeding is noted. 
 
 

SAP_001.pdf: 
Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 1 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
Confidentiality statement: 
• 
The information provided in this document is strictly confidential. 
• 
The recipients of the SAP must not disclose the confidential information contained within 
this document or any related information to other persons without the permission of the 
sponsor. 
• 
In addition, the recipient of the SAP must keep this confidential document in a controlled 
environment which prevents unauthorized access to the document. 
 
 
 
Protocol Title: 
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose 
Escalation Study to Evaluate the Safety, Pharmacokinetics, and 
Immunogenicity of ADM03820 in Adults 
Protocol Number: 
ADM03820-001 
Protocol Version, Date: 
V7.0, 08-AUG-2023 
ICON GPHS ID: 
5309-0008 
Document Version, Date: 
Final v4.0, 11-SEP-2023 
 
 
 
 
Prepared by: 
Xianmiao (Kelley) Qiu 
ICON GPHS Biostatistician 
On behalf of: 
Resilience Government Services 13200 NW Nano Court 
Alachua, FL 32615 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 2 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
Signature Page 
 
 
 
Prepared at ICON GPHS by: 
Xianmiao (Kelley) Qiu 
Kelley Qiu 
ICON GPHS Biostatistician 
11 Sep 2023 13:54
REASON: I approve this document as author. 
b39bf162-0abc-4324-b5c9-b222ec615edc 
:22 UTC (Z) 
Signature 
Date 
 
 
 
Approved at ICON GPHS by: 
Tracey Mason 
Tracey Mas
Executive Director, Biostatistics 
11 Sep 2023
REASON: I approve this document 
cf861a83-89e0-46c8-be99-4c2d68b8479b 
n 
13:55:25 UTC (Z) 
Signature 
Date 
 
 
 
Approved at SPONSOR by: 
Angie Kimbler 
Angie Kimbler 
RGS Director, Regulatory and Clinical Operations 
REASON: I approve this doc
a1bd9fb3-22f9-48de-8319-5df19a9d0e1 
um
8 
11 Sep 2023 14:58:26 UTC (Z) 
ent 
Signature 
Date 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 3 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
Revision History 
 
Version 
Date 
Revisions 
0.1 
03-NOV-2020 
Initial draft. 
0.2 
11-NOV-2020 
Revised draft after internal review. 
1.0 
25-NOV-2020 
Finalized version after incorporating changes in 
protocol v2.0 and additional internal comments. 
1.1 
15-MAR-2021 
Revised draft SAP incorporating changes in 
protocol v4.0. 
2.0 
16-MAR-2021 
Finalized SAP after addressing minor 
comments from sponsor. 
2.1 
06-JUL-2022 
Revised draft SAP incorporating changes in 
protocol v5.0 and PK populations. 
3.0 
13-JUL-2022 
Final version 
3.1 
27-JUL-2023 
Revised draft SAP incorporating changes in 
protocol v6.0. 
Section 1, Introduction: update the protocol 
version to 6.0. 
Section 3.0, Study design: update the total 
number of subjects to 50. Add cohort 5. 
Section 4.0, Study endpoints: update the 
primary endpoints, and secondary endpoints. 
3.2 
30-AUG-2023 
Revised draft SAP incorporating changes in 
protocol v7.0: 
Change the company name to: Resilience 
Government Services 
Section 3.0, Study design: Add “for Cohorts 3 
and 4” after “Discharge and outpatient follow- 
up (Day 2 to Day 540)”. 
Add “Discharge and outpatient follow-up (Day 
2 to Day 379) for Cohort 5”. 
Change “Subjects in all cohorts” to “Subjects in 
cohorts 1-4”. 
Add “Subjects in cohort 5 will participate 
approximately 379 days (up to a 14-day 
screening, overnight stay, and up to 12-month 
outpatient follow-up visits.)” 
Add a footnote under Table 2 schedule of 
events: “19.TC visits will be conducted for only 
Cohorts 1-4 (Not applicable for Cohort 5).” 
4.0 
11-Sep-2023 
Update Angie Kimbler’s title to “Director, 
Regulatory and Clinical Operations”. 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 4 of 26 
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Table of Contents 
1.0 
Introduction ............................................................................................................. 8 
2.0 
Study Objectives ..................................................................................................... 8 
Primary objective(s) ......................................................................................................................................... 8 
Secondary objective(s) .................................................................................................................................... 8 
Exploratory objective(s) ................................................................................................................................... 8 
Safety objective(s) ........................................................................................................................................... 8 
3.0 
Study Design ........................................................................................................... 8 
General study design ....................................................................................................................................... 8 
Randomization procedures ............................................................................................................................ 11 
Study treatments and assessments ............................................................................................................... 11 
4.0 
Study Endpoints .................................................................................................... 15 
Primary endpoint(s) ........................................................................................................................................ 15 
Secondary endpoint(s) ................................................................................................................................... 15 
Exploratory endpoint(s) .................................................................................................................................. 15 
Safety endpoint(s) .......................................................................................................................................... 15 
5.0 
Sample Size and Power ........................................................................................ 15 
6.0 
Analysis Populations ............................................................................................ 16 
Full Analysis Set (FAS)/Intention-To-Treat population (ITT) .......................................................................... 16 
Safety population (Safety) ............................................................................................................................. 16 
Per-Protocol population (PP) ......................................................................................................................... 16 
Pharmacokinetics (PK) population ................................................................................................................. 16 
Protocol deviations ......................................................................................................................................... 16 
7.0 
Statistical Considerations and Analysis .............................................................. 17 
Derived Variables ........................................................................................................................................... 17 
Handling of missing data and outliers ............................................................................................................ 18 
Missing data analysis methods ...................................................................................................................... 18 
8.0 
Statistical Methods ................................................................................................ 19 
General statistical conventions ...................................................................................................................... 19 
Subject disposition ......................................................................................................................................... 19 
Protocol deviations ......................................................................................................................................... 20 
Demographics and baseline characteristics ................................................................................................... 20 
8.4.1 
Demographics ............................................................................................................................ 20 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 5 of 26 
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8.4.2 
Baseline and disease characteristics ......................................................................................... 20 
8.4.3 
Medical history ........................................................................................................................... 20 
8.4.4 
Prior and concomitant medications ............................................................................................ 21 
Extent of exposure ......................................................................................................................................... 21 
Efficacy analysis ............................................................................................................................................ 21 
8.6.1 
Analysis methods .......................................................................................................................... 21 
8.6.2 
Multiplicity ...................................................................................................................................... 22 
8.6.3 
Treatment by center interaction analysis (multi-center study) .......................................................... 22 
8.6.4 
Analysis of primary efficacy endpoint(s) ........................................................................................ 22 
8.6.5 
Analysis of secondary efficacy endpoint(s).................................................................................... 22 
8.6.6 
Analysis of exploratory endpoint(s) ............................................................................................... 22 
Safety analysis ............................................................................................................................................... 23 
8.7.1 
Adverse events .............................................................................................................................. 23 
8.7.2 
Clinical laboratory evaluations ....................................................................................................... 24 
8.7.3 
Vital signs ...................................................................................................................................... 24 
8.7.4 
Physical examinations ................................................................................................................... 24 
8.7.5 
Electrocardiograms ........................................................................................................................ 25 
8.7.6 
Other safety assessments ............................................................................................................. 25 
8.8.1 
Subgroup analysis ......................................................................................................................... 25 
8.8.2 
PK analysis .................................................................................................................................... 25 
Interim analysis (IA) ....................................................................................................................................... 26 
9.0 
Changes to Planned Analysis from Study Protocol ........................................... 26 
10.0 
References ............................................................................................................. 26 
11.0 
Appendices ............................................................................................................ 26 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 6 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
List of Abbreviations 
 
Abbreviation 
Explanation 
ADA 
Anti-drug antibody 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
ATC 
Anatomical therapeutic chemical 
AUC 
Area under the curve 
AV 
Atrioventricular 
BMI 
Body mass index 
BPM 
Beats per minute 
BUN 
Blood urea nitrogen 
CI 
Confidence interval 
CK 
Creatine kinase 
CRF 
Case report form 
CSR 
Clinical study report 
ECG 
Electrocardiograms 
ECLA 
Electrochemiluminescence assay 
ELISA 
Enzyme-linked immunosorbent assay 
FAS 
Full analysis set 
FEV1 
Forced expiratory volume in one second 
GCP 
Good Clinical Practice 
GMFR 
Geometric mean fold rise 
GMT 
Geometric mean titer 
HBsAG 
Hepatitis B surface antigen 
HCV 
Hepatitis C virus 
HEENT 
Head, eyes, ears, nose and throat 
HIV 
Human immunodeficiency virus 
IA 
Interim Analysis 
ICH 
International Conference on Harmonisation 
IgE 
Immunoglobulin E 
IM 
Intramuscular 
INR 
International normalized ratio 
IQR 
Interquartile range 
IRT 
Interactive response technology 
ITT 
Intention-to-treat 
IV 
Intravenous 
MCH 
Mean corpuscular hemoglobin 
MCHC 
Mean corpuscular haemoglobin concentration 
MCV 
Mean corpuscular volume 
MedDRA 
Medical dictionary for regulatory activities 
MN 
Microneutralization 
MPV 
Mean platelet volume 
PE 
Physical examination 
PI 
Principal investigator 
PK 
Pharmacokinetics 
PP 
Per-protocol 
PR 
PR interval – standard ECG terminology 
PT 
Prothrombin time 
PTT 
Partial thromboplastin time 
QRS 
QRS interval – standard ECG terminology 
QT 
QT interval – standard ECG terminology 
QTcF 
QTc by Fridericia formula 
RDW 
Red cell distribution width 
RT-PCR 
Reverse transcription polymerase chain reaction 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 7 of 26 
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Abbreviation 
Explanation 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SI 
Standard international 
SOC 
System organ class 
SRC 
Safety review committee 
TLF 
Table, listing and figure 
WBC 
White blood count 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 8 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
1.0 
Introduction 
The purpose of this Statistical Analysis Plan (SAP) is to provide detailed descriptions of the statistical 
methods, data derivations, and data displays for the study protocol ADM03820-001 Version 6.0 “A Phase 1, 
Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, 
Pharmacokinetics, and Immunogenicity of ADM03820 in Adults” dated 14-JUL-2022 for final analysis. The 
table of contents and templates for the Table, Listing and Figure (TLF) will be produced in a separate 
document. 
Any deviations from this SAP will be described and justified in the Clinical Study Report (CSR). 
 
The preparation of this SAP has been based on International Conference on Harmonisation (ICH) E9 and 
Good Clinical Practice (GCP) guidelines. 
All data analyses and generation of TLFs will be performed using SAS 9.4® (or higher) and Phoenix 
WinNonLin 8.3.1 (or higher). 
 
2.0 
Study Objectives 
 
Primary objective(s) 
To assess the safety and tolerability of different doses of ADM03820 in healthy adult subjects 
 
 
Secondary objective(s) 
To assess the pharmacokinetics (PK) and immunogenicity (ADA) of different doses of ADM03820 in healthy 
adult subjects 
 
Exploratory objective(s) 
None. 
 
 
Safety objective(s) 
No additional safety objectives of current study besides the primary objective. 
 
 
3.0 
Study Design 
 
General study design 
This study is a phase 1, randomized, double-blind, placebo-controlled study of four dose cohorts. The study 
will enroll and randomize a total of 50 healthy subjects from five study sites to receive an intramuscular (IM) 
injection of either ADM03820 or placebo. Five dosing cohorts will be enrolled sequentially. Dose escalation 
will occur after the Safety Review Committee (SRC) reviews safety data and confirms that the dose 
escalation criteria are met. Within each cohort, 8 actives and 2 placebos will be included. The 5 dosing 
cohorts are 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 9 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
1. Cohort 1 –150 mg IM injection (8 active, 2 placebo) 
 
2. Cohort 2 – 300 mg IM injection (8 active, 2 placebo) 
 
3. Cohort 3 – 300 mg IM injection (8 active, 2 placebo) 
 
4. Cohort 4 – 300 mg IM injection (8 active, 2 placebo) 
 
5. 
Cohort 5 – 600 mg IM injection (8 active, 2 placebo) 
 
All enrolled subjects in Cohorts 1 and 2 will follow the study schedule below: 
 
• 
Screening (Day -14 to Day -2) 
 
• 
Baseline/admission to Unit (Day -1) 
 
• 
Dosing (Day 1) 
 
• 
Discharge and outpatient follow-up (Day 2 to Day 540) 
 
According to Protocol v7.0, subjects in Cohorts 3, 4 and 5 will be admitted to the unit the day of the planned 
dosing. Thus, study schedule is specified below: 
• 
Screening (Day -14 to Day -2) 
 
• 
Dosing (Day 1) 
 
• 
Discharge and outpatient follow-up (Day 2 to Day 540) for Cohorts 3 and 4 
 
• 
Discharge and outpatient follow-up (Day 2 to Day 379) for Cohort 5 
A schematic of the study design is summarized in Figure 1. 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 10 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
Figure 1 – Schematic of Study Design 
 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 11 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
Randomization procedures 
This is a Phase 1 double-blinded, placebo-controlled trial that will randomize subjects within five dosing 
cohorts to either active or placebo. 
For dosing Cohorts 1, 2, and 5, the first two subjects will be randomized in a 1:1 fashion to active and 
placebo to ensure that one of the first two subjects receives active treatment and the other control. An 
alternate subject will be admitted to the unit for each two-subject group. If one of the first two subjects is not 
randomized for any reason, then the alternate subject will receive the next consecutive randomization 
number. The product assignment of the remaining subjects in each cohort will follow a 7:1 randomization of 
active to placebo, respectively. The randomization list will be generated by the unblinded study biostatistician 
and uploaded to the IRT system by vendor (4G Clinical). Upon confirming eligibility of subjects, site research 
personnel will randomize subjects then the unblinded study pharmacist will be notified of treatment allocation 
via system-generated email. 
Subjects in Cohorts 3 and 4 will be randomized in a 4:1 ratio of active to placebo. The randomization list will 
be generated by the unblinded study biostatistician and uploaded to IRT system by vendor (4G Clinical). 
Upon confirming eligibility of subjects, site research personnel will randomize subjects then the unblinded 
study pharmacist will be notified of treatment allocation via system-generated email. 
The following rules apply in case of subject withdrawal: 
 
• 
Subjects who are withdrawn prior to dosing must be replaced. 
 
• 
Following dosing, one subjects per cohort may withdraw prior to the completion of Visit 11 (Day 60) 
or was noncompliant with all PK draws through Visit 6 (Day 4) without being replaced. 
• 
If 4 or more subjects withdraw, are lost to follow up or terminate prior to Day 8 within a cohort, at 
least one of those subjects need to be replaced to ensure that data for at least 7 subjects are 
available for review. 
• 
If 4 or more subjects withdraw, are lost to follow up or terminate on or after Day 8 but prior to Day 60 
or are not compliant with all PK draws through Day 15 within a cohort, they should be replaced. 
• 
If more than 4 subjects withdraw, are lost to follow up or terminate following the Day 8 SRC review of 
safety data within a cohort, the sites will attempt to replace those subjects in that dose group at the 
time of the next planned cohort. 
• 
All replaced subjects will be assigned to the same treatment assignment as the subject they are 
replacing. This will be documented in the source documents and eCRFs. 
 
Study treatments and assessments 
Subjects in cohorts 1-4 will participate for an approximate duration of 554 days (up to a 14-day screening, 
overnight stay, up to 12-month outpatient follow-up visits and telephone visits at 15-months and 18-months). 
Subjects in cohort 5 will participate for approximately 379 days (up to a 14-day screening, overnight stay, and 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 12 of 26 
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up to 12-months of outpatient follow-up visits.) All eligible subjects in Cohorts 1, 2, and 5 will be admitted to 
clinical unit on Day -1, receive the randomized treatment on Day 1, and be discharged from unit on Day 2. All 
eligible subjects in Cohorts 3 and 4 will be admitted to clinical unit and receive the randomized treatment on 
Day 1, and to be discharged from unit on Day 2. Fourteen scheduled outpatient visits are planned for each 
subject, including the final study visit and two telephone visits. 
 
Patients will be enrolled into 5 dosing cohorts (see Section 3.1) sequentially with interim review of safety data 
through Day 8 at current dosing level. Each dosing cohort consists of 8 subjects receiving active treatments 
and 2 receiving placebos. Refer to protocol Section 9.5 for Halting Rules, including halting criteria for the 
study, dose escalation halting criteria and evaluation of dose escalation. 
 
A detailed description of procedures and assessments to be conducted during this study is summarized in 
the Schedule of Events in Table 1 below. 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 13 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
TABLE 2 - SCHEDULE OF EVENTS 
 
Study Visit 
Screening1 
01 
Baseline/Dosing 
02 
Discharge 
03 
04 
05 
06 
07 
08 
09 
10 
11 
12 
13 
Study Day (Window) 
-14 to -2 
1 
2 
3 
4 
8±2 
15±2 
30±2 
45±3 
60±3 
90±3 
120±5 
150±
Review Inc/ ExcI Criteria 
X 
X 
Review Medical History 
X 
X 
Review 
Contraception/menses 
X 
Perform Abbreviated PE3 
X 
Perform Symptom-Directed 
PE14 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signs4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Screening Labs5 
X 
Clinical Safety Labs,6 
X 
X 
X 
X 
Serum β-HCG 
X7 
Urine pregnancy test 
X 
X 
X 
X 
X 
Urine Dipstick8 
X 
X 
X 
X 
Urine Toxicology 
X 
X 
Breathalyzer test 
X 
X 
Immunogenicity (ADA)15 
X 
X 
X 
X 
X 
X 
X 
X 
PK samples11 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MN Samples 
X 
X 
X 
X 
X 
X 
X 
X 
Hypersensitivity Panel16 
X 
12-lead ECG9 
X 
X 
Viral Serology10 
X 
SARS-CoV-2 Antibodies18 
X 
RT-PCR17 
X 
X 
Concomitant Medications2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization 
X 
Study Drug Administration 
X 
Future Use Sample12 
X 
X 
X 
X 
Counsel on the avoidance of 
pregnancy 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAE Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1. 
Screening will be completed within 14 days prior to administration of study drug and may require more than one visit. 
2. 
Concomitant medications including all of the following: prescription drugs, over-the–counter drugs, herbs, vitamins, nutritional 
supplements, illicit and recreational substance use, birth control 
3. 
PE includes height and weight at screening. 
4. 
Vital Signs to include sitting diastolic and systolic blood pressure, heart rate, respiratory rate, and oral temperature. See section 8 for a 
schedule of when vital signs are to be obtained. 
5. 
Screening Laboratory Tests that will include hemoglobin, WBC with differential, absolute neutrophil count and platelet count. MCV, 
MCH, MCHC, RDW, MPV, which are included in a complete blood count with differential, will not be graded, serum creatinine, BUN, 
calcium, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, and total 
CK. Include FSH at screening to confirm post-menopausal status for women ≥ 1 year without menses 
6. 
Clinical Safety Laboratory Tests that will include hemoglobin, WBC with differential, absolute neutrophil count and platelet count. MCV, 
MCH, MCHC, RDW, MPV, which are included in a complete blood count with differential, will not be graded, serum creatinine, BUN, 


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calcium, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, PT, PTT, INR, ALT, AST, sodium, potassium, and total 
CK. 
7. 
A serum pregnancy test will be obtained for all women of reproductive capacity. Results must be confirmed as negative before study 
product is dosed. 
8. 
A urine dipstick will be done to evaluate for presence of protein, glucose or blood in urine. If dipstick is abnormal, a complete urinalysis 
with microscopic will be performed. 
9. 
A 12-lead ECG will be performed during screening and post dose performed 30 minutes (±10 minutes) after completion of dosing. 
10. Viral Serology includes HIV, HBsAg and antibody to HCV. 
11. PK samples will be taken at the following times: pre-dose, 2, 4, 8, and 24 hours post injection and on days 2, 3, 4, 8, 15, 30, 45, 60, 90, 
120, 150, 180, and 365 for all cohorts 
12. Serum from subjects who give consent for future use samples will be collected at 2 hr and 4 hr post dose and on days 2, 8, and 30 
13. Vital signs (sitting for at least 10 minutes) will be checked just before injection and every visit. 
14. The subject will be under direct observation during at least the initial 30 minutes of dosing. A physical examination will be performed at 
approximately 30 minutes post injection or in response to subject symptoms which will include the following: General appearance 
including alertness, diaphoresis, chills, and any difficulty breathing, HEENT, Chest, Heart, Skin and Joints 
15. 
Draw prior to dosing at baseline 
16. 
The Hypersensitivity Panel includes cytokine and complement panels, IgE, and tryptase. Draw 14ml prior to dosing. If a subject 
develops anaphylaxis or anaphylactoid reaction, an additional 10 mL sample will be drawn during the event, and another will be drawn 
after the event 
17. 
Subjects in all cohorts will receive RT-PCR testing at screening, Day 1 prior to dosing, and at presentation of symptoms. 
18. 
SARS-CoV-2 antibodies will only be tested in Cohorts 1-4 (Not applicable for Cohort 5) 
19. 
TC visits will be conducted for only Cohorts 1-4 (Not applicable for Cohort 5). 
 
Study Endpoints 
 
Primary endpoint(s) 
• 
The occurrence of Serious Adverse Events following administration of ADM03820 to the final follow-up 
visit. 
• 
The occurrence of adverse events (AEs) from administration of ADM03820 to the final follow-up visit. 
• 
The occurrence of changes from baseline in physical examination, vital signs, and clinical safety 
laboratory values following administration of ADM03820 to the final follow-up visit. 
 
Secondary endpoint(s) 
• 
The assessment of Cmax, Tmax and AUC(0-t) for total antibodies of ADM03820 as measured by Enzyme- 
linked Immunosorbent Assay (ELISA) for samples from Cohorts 1 and 2. The assessment of Cmax, Tmax 
and AUC(0-t) for each of the monoclonal antibodies of ADM03820 as measured by enzyme-linked 
immunosorbent assay (ELISA) for samples from Cohort 3,Cohort 4 and Cohort 5. 
o 
Pharmacokinetic samples will be tested by ELISA at pre-dose, 2, 4, 8, and 24 hours post dose, 
and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365 for all cohorts 
o 
Samples will be tested by Microneutralization at pre-dose and Days 2, 15, 30, 60, 90, 120, 150, 
and 180 for all cohorts 
• 
Samples will be tested by Electrochemiluminescence Assay (ECLA) to evaluate presence of anti-drug 
antibodies (ADA) collected for all cohorts. 
o 
ADA samples will be tested at pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, 180, 365 for all 
cohorts 
• 
Incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring after dosing 
through Day 365 
• 
Incidence of SARS-CoV-2 RT-PCR positive severe or critical symptomatic illness occurring after dosing 
through Day 365 


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• 
Incidence of COVID-19 related Emergency Department visits occurring after dosing through Day 365 
 
 
Exploratory endpoint(s) 
None. 
 
 
Safety endpoint(s) 
No additional safety endpoints besides those specified in Section 4.1. 
 
 
4.0 
Sample Size and Power 
This is a Phase 1 study first in humans with four dosing cohorts and no formal sample size calculations 
based on testing a statistical hypothesis were constructed. Sample sizes are consistent with this type of early 
phase study. Dosing groups of ten participants each, eight participants assigned the active group and two 
assigned to the control group, for each cohort are practical and provide sufficient information for a total 
sample size of 40 for a Phase 1 trial primarily designed to assess safety. 
The dosing groups of eight participants in the active group has a probability of at least one subject 
experiencing an event of toxicity ranges from 0.728 to 0.996 assuming true event rates are between 0.15 
and 0.5. 
Additionally, if no events are observed in each scenario described above, the upper bound of an exact 95% 
confidence interval for the true proportion is 0.369. 
 
5.0 
Analysis Populations 
 
Full Analysis Set (FAS)/Intention-To-Treat population (ITT) 
 
An intent-to-treat population will consist of all subjects randomized and will be analyzed as randomized. 
 
Safety population (Safety) 
All subjects who received study product will be included in the safety population and analyzed as treated. 
 
 
Per-Protocol population (PP) 
The Per-protocol population will consist of all subjects in the ITT population who were free from major 
protocol violations. Patients will be included in the analysis according to the treatment group they are 
randomized to. 
 
Pharmacokinetics (PK) population 
The PK population will consist of all subjects who complete ADM03820 injection and have sufficient 
evaluable PK samples for the estimation of PK parameters. Subjects in the PK population will be analyzed in 
the dose cohort and treatment group corresponding to the study drug that they have received. 


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Protocol deviations 
Protocol deviation data will be captured in the clinical trial management system. Extracts of all protocol 
deviations will be reviewed periodically and prior to any interim or final analyses. All protocol deviations and 
the exclusion of participants from analysis sets will be identified prior to unblinding through clinical review 
and input provided by the sponsor using supportive participant listings provided by the ICON GPHS 
statistician based upon data recorded in the clinical trial management system. 
Further, deviations from the protocol will be classified as major or minor. Classification of major and minor 
protocol deviations is determined prior to participant enrollment and is outlined in detail in the protocol 
deviation criteria documentation managed by the clinical trial management team. 
 
6.0 
Statistical Considerations and Analysis 
 
Derived Variables 
The below table provides the list of derived variables for demographic and baseline characteristics, various 
duration derivations, baseline derivation and other important derivations applicable for this study. 
Table 3: Derived Variables 
 
Variables 
Formula 
Demographic and Baseline Characteristics 
Age at informed consent 
(in years) 
Integer ((date of informed consent – date of birth + 1) / 365.25) 
Body Mass Index 
Weight (kg) / [height (m)]2 
Derivation of Durations 
Study day at any visit 
Date of interest – date of first dose of vaccine. One day is added if the difference is ≥ 0. 
Duration of any events 
End date of event – start date of event + 1 
Baseline Derivations 
Laboratory results/vital 
signs baseline 
The baseline value is defined as the last observation prior to or on the date of dosing. 
Derivations of Changes 
Change from baseline 
Post baseline value – baseline 
Change from previous 
visit 
Current value – previous value 
Change after dosing from 
before dosing 
Value after dose – value before dose 
Pharmacokinetic Parameters (PK) (Plasma/Serum) 


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Variables 
Formula 
Cmax 
Maximum observed concentration, occurring at time Tmax. 
Tmax 
Time of maximum observed concentration. For non-steady-state data, the entire curve is 
considered. If the maximum observed concentration is not unique, then the first 
maximum is used. 
AUC(0-t) 
Area under the concentration time-curve from the time of dosing to the time of the last 
measurable (positive) concentration 
λz 
First-order rate constant associated with the terminal (log-linear) portion of the curve, 
estimated by linear regression of time vs. log concentration during steady-state 
elimination 
AUC(0-∞) 
Area under the concentration time-curve from time of dosing extrapolated to infinity, 
based on the last observed concentration or last predicted concentration defined as 
AUC(0-t) + (C(0-t)/λz) 
t1/2 
Terminal half-life defined as ln(2)/ λz as measured during steady-state 
CL 
Total body clearance for extravascular administration defined as Dose/ AUC(0-∞) 
VZ 
Volume of distribution based on the terminal phase. For non-steady-state data defined 
as Dose/[ λz (AUC(0-∞))] 
 
Handling of missing data and outliers 
All attempts will be made to collect all data per protocol. No imputations will be conducted for missing values. 
Outliers identified during the PK analysis will be discussed in the analysis report. 
 
Missing data analysis methods 
Imputation rules for missing or partial adverse event start/stop dates 
 
• 
If the AE start date day is missing (month and year provided) then set the date to the first of the 
month unless the month and year are the same as the first dose of study drug. In this case, set the 
date to the date of first dose. 
• 
If the AE start date month is missing (year is provided) then set the month and day to January 1, 
unless the year is the same as the year of the first dose. In this case, set the date to the date of first 
dose. 
• 
If the AE end date day is missing (month and year provided) then set the date to the last day of the 
month. 
• 
If the AE end date month is missing (year is provided) then set the date to December 31. 


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• 
If the year of the AE start date or AE end date are missing, then a query to the site must be made to 
gather additional information. If the end date and start date are both missing, then no imputation will 
be done. If the stat date remains missing but the end date is before first dose date, then the AE will 
be considered before treatment. If the end date is after the first dose, then the AE will be considered 
to have been treatment emergent. 
Imputation rules for missing or partial medication start/stop dates 
 
Start Date: 
 
• 
If only day is missing, use the first day of the month. 
 
• 
If day and month are missing, use the first day of the year. 
 
• 
If day, month, and year are missing use the first day of the year with the same year as the first dose. 
 
End Date: 
 
• 
If only day is missing, use the last day of the month. 
 
• 
If day and month are missing, use the last day of the year. 
 
• 
If day, month, and year are missing assign ‘continuing’ status to the stop date. 
 
 
7.0 
Statistical Methods 
 
General statistical conventions 
All statistical procedures will be completed using SAS version 9.4 (or higher), R version 4.0.0 (or higher), or 
Phoenix WinNonLin 8.3.1 (or higher). 
Unless otherwise stated, all statistical testing will be two-sided and will be performed using a significance 
(alpha) of 0.05. Two-sided 95% confidence intervals (CI) will be provided when relevant. 
Continuous variables will be summarized using descriptive statistics, including number of subjects (n), mean, 
median, standard deviation (SD), interquartile ranges (IQR), minimum, and maximum. 
For categorical variables, summaries will include counts of subjects and percentages. Percentages will be 
rounded to one decimal place. 
For summary purposes, baseline will be defined as the last available pre-dose value. All summaries will be 
presented by treatment group, unless otherwise specified. 
All subject data, including those derived, will be presented in individual subject data listings. Unless 
otherwise stated, unscheduled visit results will be included in date/time chronological order, within patient 
listings only. All listings will be sorted by subject ID, date/time and visit. The treatment group will be stated on 
each listing. Unless otherwise stated, data listings will be based on FAS. 


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Unscheduled data points will not be used in any summary tables separated by visit but will be presented in 
each listing as appropriate. 
 
Subject disposition 
Subject disposition information will be summarized by dosing cohort, treatment group and overall. The 
number and percentage of subjects who are enrolled, who complete the study, and who withdraw early from 
the study will be presented. 
The primary reasons for early withdrawal will also be tabulated, including withdrawal by subject, physician 
decision, lost to follow-up, major protocol deviation or other. 
The number of subjects enrolled will be used as the denominator for the percentage calculation. Subject 
disposition will be listed. 
The number and percent of subjects in each analysis set will also be tabulated. A listing of each subject 
excluded from an analysis population will be listed as well as the reason why they were excluded from the 
population. 
Treatment Misallocations: if a subject is 
 
• 
Randomized but withdrawn prior to dosing, then they will be replaced and will not be included in any 
analysis. 
• 
Randomized but receive incorrect treatment, they will be reported under the treatment they actually 
have received for all safety analysis and PK analysis. 
 
Protocol deviations 
The number of patients excluded from FAS/ITT, Safety, and Per-protocol analysis sets and reasons for 
exclusion will be summarized by treatment group and overall. 
Population membership details will be listed, including reason for exclusion from each population. 
 
Protocol deviation data are not captured in the clinical database and therefore will not be reported 
individually within the scope of the SAP. Protocol deviations will be summarized in the final clinical study 
report. 
 
Demographics and baseline characteristics 
 
8.4.1 
Demographics 
Age at consent, height, weight, BMI and other continuous demographic variables at baseline will be 
summarized descriptively. Sex, race, ethnicity and other categorical variables will be summarized using the 
ITT/FAS population. 


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8.4.2 
Baseline and disease characteristics 
The baseline continuous characteristics (vital signs) will be summarized descriptively for the ITT population. 
The baseline categorical characteristics (results of physical exams, ECG, serum chemistry, hematology and 
urinalysis, serology) will be summarized using frequency counts and percentages for the safety population. 
 
8.4.3 
Medical history 
A summary of medical history and defined high-risk comorbidities will be presented by system organ class 
(SOC) and Preferred Term using the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. 
Medical history will be graded for severity. 
 
8.4.4 
Prior and concomitant medications 
Medications used in this study will be coded by using MedDRA version 23.0. 
 
Prior medications are defined as those medications with a start date 28 days prior to the initial screening. 
 
Concomitant medications are defined as those medications with a start state later than 28 days prior to the 
initial screening and will be recorded at screening visit. At each subsequent study visit each new concomitant 
medication and changes to existing medications will be recorded. Subjects will be required not to utilize non- 
study medication or herbal supplements during the study except those deemed necessary by the site 
Principal Investigator (PI) or sub investigator. Any drug (e.g., over-the-counter herbal supplement, vitamins 
or prescription) used by the subject during the course of the trial will be recorded in the subject’s source 
documents and on the appropriate eCRF. Per protocol section 5.2 exclusion criteria #20, subjects using any 
of the prohibited medications within 28 days prior to screening or planned use during the study period will be 
excluded from the study. However, if any prohibited medication is used during study period by any enrolled 
subject, it would be captured as a protocol deviation at local sites. 
Prior and concomitant medications will be summarized descriptively using frequency tables by Anatomical 
Therapeutic Chemical (ATC) class and preferred name by treatment group on the ITT population and 
presented separately for the following groups: 
• 
Medications prior to 28 days before the initial screening. 
 
• 
Concomitant medications continued after initial screening. 
 
• 
Concomitant medications started at or after the initial screening. 
 
• 
Prior and concomitant use of any restricted medications as described in protocol exclusion criteria. 
 
Details for imputing missing or partial start and/or stop dates of medication are described in section 7.3. 


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Extent of exposure 
A single dose of study product will be administered on-site by research personnel at Day 1 (Visit 2 per 
protocol v7.0) for all subjects. All study products will be administered via IM injection. Thus, treatment 
compliance will not be applicable. 
 
Efficacy analysis 
Efficacy analysis is only applicable to the secondary endpoints regarding immunogenicity described in 
section 4.2 and analysis methods are described in section 8.6.5 below. 
 
8.6.1 
Analysis methods 
Refer to section 8.6.5 for analysis methods for secondary endpoints regarding immunogenicity. 
 
 
8.6.2 
Multiplicity 
Each immunogenicity endpoint will be analyzed separately, and no multiplicity will be corrected. 
 
 
8.6.3 
Treatment by center interaction analysis (multi-center study) 
Five study centers will be involved in the study; however, all subjects will be pooled for secondary efficacy 
analysis and no treatment by center interaction will be examined. 
 
8.6.4 
Analysis of primary efficacy endpoint(s) 
Not applicable. 
 
 
8.6.5 
Analysis of secondary efficacy endpoint(s) 
Secondary efficacy analysis will be based on microneutralization assay and immunogenicity/ADA assay 
using blood samples drawn at various predetermined visit days using per-protocol population. 
Pharmacokinetic (PK) and Log-Transformed Pharmacokinetic (PK) Parameters will be summarized 
descriptively by treatment group. 
Microneutralization titers will be summarized descriptively by treatment group and compared among 
treatment groups using Kruskal-Wallis test on log scale. GMT of ADA and GMFR over the initial GMT at 
baseline will be summarized descriptively by treatment group and compared using Kruskal-Wallis test among 
cohorts at each study visits. Exploratory pairwise comparisons will also be conducted using Wilcoxon rank 
sum test; however, resulting p-values will not be corrected for multiplicity. Microneutralization titers on log 
scale and GMTs for ADA will be plotted by treatment group over study days. 
Incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring after dosing 
through Day 365 will be summarized descriptively by treatment group. Incidence of SARS-CoV-2 RT-PCR 


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positive severe or critical symptomatic illness occurring after dosing through Day 365 will be summarized 
descriptively by treatment group. 
Incidence of COVID-19 related Emergency Department visits occurring after dosing through Day 365 will be 
summarized descriptively by treatment group. 
Due to the small number of subjects in this study, negative hypothesis tests should be interpreted carefully 
as the study has not been powered to detect differences between groups. 
 
8.6.6 
Analysis of exploratory endpoint(s) 
Not applicable. 
 
 
Safety analysis 
This section describes the safety analyses that will be conducted on the treatment and follow-up periods (i.e., 
the safety analyses on all data collected during the treatment and follow-up periods and all data collected in 
subjects who dropped-out during the treatment and follow-up periods). 
All definitions relative to safety endpoints (primary endpoints) are detailed in section 4.1. 
 
Safety analyses will be conducted on the safety population and will be performed for all safety variables 
specified below. 
All safety data will be summarized by treatment group. 
 
The safety analyses of changes from baseline to a specific time point in safety variables (e.g., laboratory 
parameters, physical examinations, vital signs) will only include subjects from the safety population who have 
data available for both the baseline and the time point under considerations unless otherwise specified. 
No statistical tests will be performed on the safety endpoints. 
 
 
8.7.1 
Adverse events 
All AEs will be classified by Primary SOC and Preferred Term according to the MedDRA Version 23.0 or 
higher. The occurrence of AEs and SAEs following administration of ADM03820 to the final follow-up visit will 
be categorized as solicited adverse events, unsolicited adverse events and lab abnormalities. A summary 
table will be provided to summarize the frequencies and percentages of each category and overall by 
treatment group. Subsequent analyses will be conducted for each category, respectively, by severity, 
relationship to study medication, and by MedDRA level hierarchy (SOC and Preferred Term). 
The occurrence of changes from baseline in physical examination, vital signs and clinical safety laboratory 
values following administration of ADM03820 to the final follow-up visit will be summarized descriptively by 
treatment group. AEs will be collected at Day 1 during and after dosing. Any medical condition that is present 
at the time that the subject is screened should be considered as baseline and not reported as an AE. 
However, if the condition increases in severity or frequency at any time during the study, it will be recorded 


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as an AE. Severity and relationship to the treatment will be assessed by investigator: severity is graded 
according CTCAE v5.0; relationship to the treatment is categorized as not related, possibly related, and 
definitely related. 
Where a subject has the same adverse event, based on preferred terminology, reported multiple times in the 
treatment period, the subject will only be counted once at the preferred terminology level in adverse event 
frequency tables. Where a subject has multiple adverse events within the same system organ class in the 
treatment period, the subject will only be counted once at the system organ class level in adverse event 
frequency tables. Under both scenarios, the event of the worst severity or the worst-case relationship 
assessment will be used for summarizing safety endpoints. 
AEs will be followed until resolution or stability even if this extends beyond the study-reporting period. 
Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the 
expectation that it will remain chronic. Follow-up procedures, evaluations, and outcomes will be recorded on 
the subject's case report forms and will be presented using individual patient listings. 
Details for imputing missing or partial start dates of adverse events are described in section 7.2.2. 
 
In summaries by SOC and Preferred Term, adverse events will be sorted by descending frequency within 
each SOC and Preferred Term according to the total number of events. In summaries by Preferred Term, 
AEs will be sorted by decreasing frequency according to the total number of events. 
 
8.7.2 
Clinical laboratory evaluations 
Clinical laboratory evaluations include serum chemistry, hematology, and urinalysis. For the purposes of 
summarization in both the tables and listings, all laboratory values will be presented in SI units. If a lab value 
is reported using a nonnumeric qualifier e.g., less than (<) a certain value, or greater than (>) a certain value, 
the given numeric value will be used in the summary statistics, ignoring the nonnumeric qualifier; but will be 
listed as is in the listings. Severity of abnormal laboratory results will be graded according to CTCAE v5.0. 
All laboratory data obtained between screening visit and the end of study will be used for the laboratory 
safety analysis. Laboratory summaries will be provided including values measured during the follow-up 
period, where appropriate. 
Visit value and change and from baseline during the treatment period will be summarized by treatment group 
using descriptive statistics for all laboratory parameters. 
Abnormal clinical laboratory results will be summarized by treatment group and severity at subsequent visits 
following screening when clinical safety labs are performed. Abnormality will be determined according to the 
pre-specified criteria at each site (which may vary by sites) and flagged in EDC. 
Subjects with graded laboratory values will be identified in listings, including patient information, visit date, 
severity of abnormality, relationship to study product along with specifics of the abnormal laboratory results 
and corresponding normal ranges (when applicable). 


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8.7.3 
Vital signs 
Visit values and changes from baseline for vital sign measurements (blood pressure, oral temperature, heart 
rate and respiratory rate) will be summarized by treatment group at each visit or timepoint using descriptive 
statistics. Visit values will be calculated as the mean of all available measurements per parameter. Subjects 
with vital signs will be listed and summarized by treatment group. 
 
8.7.4 
Physical examinations 
An abbreviated physical examination (PE) will be conducted at the screening visit and Day -1. Symptom- 
directed PEs will be performed at all other subsequent visits. Any new findings on PE post dosing or 
worsening of existing conditions will be reported as AEs, which will be summarized descriptively by treatment 
group using frequencies and percentages. Subjects with documented AEs based on PEs will be identified 
using listings and summarized by treatment group and study day. Abnormal physical exams will be 
summarized by treatment group. 
 
8.7.5 
Electrocardiograms 
12-lead ECG will be performed at screening and on dosing day (30±10 minutes after injection) while subject 
is in supine position using an ECG machine that automatically calculates the heart rate and measures PR, 
QRS, and QT (QTcF), intervals. Results will be categorized as normal sinus rhythm, normal variant and 
abnormal. Results at each study day will be summarized using frequency tables. Any changes after injection 
from baseline will be summarized using shift tables and subjects with abnormal ECG results after dosing will 
be identified using listings. 
 
8.7.6 
Other safety assessments 
A hypersensitivity panel includes cytokine and complement panels, IgE and tryptase. A blood sample will be 
drawn prior to dosing and additional two blood samples will be drawn during and after the event if a subject 
develops anaphylaxis or anaphylactoid reaction. The samples will only be processed if the subject has a 
hypersensitivity reaction. Subjects with hypersensitivity reaction will be identified using listings and 
summarized descriptively by treatment group. 
A nasopharyngeal swab specimen will be collected for RT-PCR testing for SARS-CoV-2 at screening and 
upon presentation of COVID-19 symptoms. Subjects with positive testing results will be identified using 
listings and summarized descriptively by treatment group. 
 
8.8.1 
Subgroup analysis 
No planned subgroup analysis will be conducted. 
 
 
8.8.2 
PK analysis 
PK parameters will be estimated for total antibodies of ADM03820 as measured by ELISA for samples from 
Cohorts 1 and 2. PK parameters for each monoclonal antibodies of ADM03820 as measured by ELISA for 


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samples from Cohorts 3-4 using noncompartmental methods. All analysis will be conducted in WinNonlin or 
a similar software package. Parameters will be estimated by dose cohort. Summary statistics will include the 
mean, median, coefficient of variation, and range. When evaluable, estimated PK parameters will include: 
• 
AUC(0-t): Area under the concentration time-curve to the last concentration above the lower limit of 
quantitation 
• 
Cmax: Maximum observed concentration 
• 
Tmax: Time of maximum observed concentration 
• 
λz: Elimination rate constant 
• 
AUC(0-∞): Area under the concentration time-curve extrapolated to infinity 
• 
t1/2: Terminal elimination half-life 
• 
CL: Total clearance 
• 
Vz: Volume of distribution 
Additionally, multi-compartmental models will be considered based on inspection of concentration-time 
curves. If models are fit, base models will assume first-order elimination from the central compartment, and 
models will be parameterized in terms of clearance, volume of distribution and inter-compartmental rates. 
Standard objective goodness of fit measures will be used to determine the final model. 
 
Interim analysis (IA) 
Two blinded interim analyses are planned for this study. See Table 4 below for their schedule and scope. No 
adjustment for multiplicity will be made at these interim analyses. 
Table 4: Schedule and scope of IAs 
 
IA Number 
Time 
Cohorts 
Scope 
1 
Day 30 
Cohorts 1 and 2 
Safety, PK 
2 
Day 60 
Cohorts 1-3 
PK 
3 
Day 60 
Cohort 5 
Safety, PK 
4 
Day 90 
Cohort 1-4 
Safety 
Refer to Section 8.6.5 and Section 8.8.2 for analysis methods. An interim CSR will be generated after all 
subjects complete Day 90. 
 
8.0 
Changes to Planned Analysis from Study Protocol 
Added per-protocol population in protocol section 11.3.1. 


Statistical Analysis Plan (SAP) 
Resilience Government Services, ADM03820-001 
BST1302-SOP-T01/v1.0/2020 
Version: Final v4.0, Date: 11-SEP-2023 
Page 26 of 26 
DocUUID : 0eaac8b3-2cdf-498a-8cee-52eba76cbe85 
 
 
9.0 
References 
None. 
 
 
10.0 
Appendices 
None.