Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04592549

Enrollment

Registered

2020-10-19

Start date

2020-12-04

Completion date

2023-10-06

Last updated

2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2

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.

Interventions

DRUGADM03820

ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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 (\> or = 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 Ology Bioservices MM. 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 1. 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. 2. Menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. 3. 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 subject 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.

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 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 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.

Design outcomes

Primary

Measure	Time frame	Description
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo	Determine number of SAEs after dosing through the final visit
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo	Determine the number of AEs after dosing
The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	540 days	The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.

Secondary

Measure	Time frame	Description
The Assessment of the Area Under the Plasma Concentration (AUC(0-t)) for the Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).	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	—
The Assessment of Peak Plasma Concentration (Cmax) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).	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	—
The Assessment of Tmax for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).	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	—
The Assessment of Area Under the Plasma Concentration (AUC(0-t)) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).	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	—
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing	365 days	—
The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing	365 days	—
The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing	365 days	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods	180 days	—
Presence of Anti-drug Antibody (ADA) Levels	pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180	This outcome looks at the total number of participants who had ADA levels at each time point
The Assessment of Peak Plasma Concentration (Cmax) for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).	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	—
The Assessment of Tmax for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).	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	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cohort 1: 150 mg IM Injection of Active Drug or Placebo Subjects in cohort 1 received a 150 mg dose IM injection of active drug. Cohort 1 will dose 8 subjects to active drug ADM03820: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies Placebo: Placebo	8
Cohort 2: 300 mg IM Injection of Active Drug or Placebo Subjects in cohort 2 received a 300 mg IM injection of active drug. Cohort 2 will dose 8 subjects to active drug ADM03820: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies Placebo: Placebo	8
Cohort 3: 300 mg IM Injection of Active Drug or Placebo Subjects in cohort 3 received a 300 mg IM injection of either active drug. Cohort 3 will dose 8 subjects to active drug ADM03820: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies Placebo: Placebo	8
Cohort 4: 300 mg IM Injection of Active Drug or Placebo Subjects in cohort 4 received a 300 mg IM injection of either active drug. Cohort 4 will dose 8 subjects to active drug ADM03820: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies Placebo: Placebo	6
Cohort 5: 600 mg IM Injection of Active Drug or Placebo Subjects in cohort 5 received a 600 mg IM injection of either active drug. Cohort 5 will dose 8 subjects to active drug ADM03820: ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies Placebo: Placebo	8
Placebo Subjects in the placebo group received normal saline. The placebo group will consist of 10 subjects. Normal Saline: Normal saline, 0.9% Sodium chloride Injection, US Pharmacopeia \[USP\]	10
Total	48

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Lost to Follow-up	2	0	0	1	1	1
Overall Study	Withdrawal by Subject	0	1	0	1	1	0

Baseline characteristics

Characteristic	Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Total	Placebo	Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Cohort 2: 300 mg IM Injection of Active Drug or Placebo
Age, Customized ages 18-55 years	8 Participants	48 Participants	10 Participants	8 Participants	6 Participants	8 Participants	8 Participants
BMI	27.50 kg/m^2 STANDARD_DEVIATION 3.769	27.84 kg/m^2 STANDARD_DEVIATION 3.873	27.04 kg/m^2 STANDARD_DEVIATION 3.971	30.40 kg/m^2 STANDARD_DEVIATION 3.509	27.25 kg/m^2 STANDARD_DEVIATION 4.533	26.14 kg/m^2 STANDARD_DEVIATION 3.802	28.75 kg/m^2 STANDARD_DEVIATION 3.418
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	15 Participants	2 Participants	2 Participants	4 Participants	3 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants	33 Participants	8 Participants	6 Participants	2 Participants	5 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Height (cm)	173.14 cm STANDARD_DEVIATION 13.44	168.91 cm STANDARD_DEVIATION 167.75	172.46 cm STANDARD_DEVIATION 8.654	170.31 cm STANDARD_DEVIATION 10.502	166.05 cm STANDARD_DEVIATION 6.859	165.76 cm STANDARD_DEVIATION 7.202	164.16 cm STANDARD_DEVIATION 8.75
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	6 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	40 Participants	8 Participants	7 Participants	5 Participants	7 Participants	8 Participants
Region of Enrollment United States	8 participants	48 participants	10 participants	8 participants	6 participants	8 participants	8 participants
Sex: Female, Male Female	2 Participants	25 Participants	4 Participants	5 Participants	3 Participants	5 Participants	6 Participants
Sex: Female, Male Male	6 Participants	23 Participants	6 Participants	3 Participants	3 Participants	3 Participants	2 Participants
Weight	82.64 kg STANDARD_DEVIATION 15.56	79.75 kg STANDARD_DEVIATION 14.532	80.71 kg STANDARD_DEVIATION 13.984	88.56 kg STANDARD_DEVIATION 15.208	75.72 kg STANDARD_DEVIATION 17.332	71.79 kg STANDARD_DEVIATION 10.707	77.84 kg STANDARD_DEVIATION 13.175

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 8	0 / 8	0 / 6	0 / 8	0 / 10
other Total, other adverse events	7 / 8	7 / 8	8 / 8	2 / 6	5 / 8	8 / 10
serious Total, serious adverse events	1 / 8	1 / 8	0 / 8	0 / 6	0 / 8	0 / 10

Outcome results

Primary

The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit

Determine the number of AEs after dosing

Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	7 Participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	7 Participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	8 Participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	2 Participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	5 Participants
Placebo	The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	8 Participants

Primary

The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit

The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.

Time frame: 540 days

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	3 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in clinical safety laboratory values	0 participants
Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in vital signs	0 participants
Placebo	The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit	Changes from baseline in physical examination	1 participants

Primary

The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit

Determine number of SAEs after dosing through the final visit

Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	1 Participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	1 Participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	0 Participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	0 Participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	0 Participants
Placebo	The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	0 Participants

Secondary

Presence of Anti-drug Antibody (ADA) Levels

This outcome looks at the total number of participants who had ADA levels at each time point

Time frame: pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Pre-dose	2 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 120	1 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 180	3 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 30	1 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 90	2 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 60	1 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 45	1 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 15	1 participants
Cohort 1: 150 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 150	2 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 90	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 120	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 15	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 180	3 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 30	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 45	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Pre-dose	0 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 150	4 participants
Cohort 2: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 60	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 90	1 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 45	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 60	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Pre-dose	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 120	5 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 30	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 15	0 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 150	2 participants
Cohort 3: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 180	1 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 15	1 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Pre-dose	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 30	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 45	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 60	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 90	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 120	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 150	0 participants
Cohort 4: 300 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 180	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 45	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 30	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 180	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 150	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 15	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 60	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Pre-dose	1 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 120	0 participants
Cohort 5: 600 mg IM Injection of Active Drug or Placebo	Presence of Anti-drug Antibody (ADA) Levels	Day 90	0 participants

Secondary