Trial Outcomes & Findings for Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19 (NCT NCT04592549)

NCT ID: NCT04592549

Last Updated: 2025-03-07

Results Overview

Determine number of SAEs after dosing through the final visit

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
• Results posted on: 2025-03-07

Participant Flow

Participant milestones

Measure	Cohort 1: 150 mg IM Injection of Active Drug 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	Cohort 2: 300 mg IM Injection of Active Drug 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	Cohort 3: 300 mg IM Injection of Active Drug 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	Cohort 4: 300 mg IM Injection of Active Drug 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	Cohort 5: 600 mg IM Injection of Active Drug 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 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 \[USP\]
Overall Study STARTED	8	8	8	6	8	10
Overall Study COMPLETED	6	7	8	4	6	9
Overall Study NOT COMPLETED	2	1	0	2	2	1

Reasons for withdrawal

Measure	Cohort 1: 150 mg IM Injection of Active Drug 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	Cohort 2: 300 mg IM Injection of Active Drug 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	Cohort 3: 300 mg IM Injection of Active Drug 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	Cohort 4: 300 mg IM Injection of Active Drug 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	Cohort 5: 600 mg IM Injection of Active Drug 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 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 \[USP\]
Overall Study Withdrawal by Subject	0	1	0	1	1	0
Overall Study Lost to Follow-up	2	0	0	1	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]	Total n=48 Participants Total of all reporting groups
Age, Customized ages 18-55 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	10 Participants n=8 Participants	48 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	25 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	23 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	15 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	33 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	40 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	6 participants n=4 Participants	8 participants n=21 Participants	10 participants n=8 Participants	48 participants n=8 Participants
Height (cm)	173.14 cm STANDARD_DEVIATION 13.440 • n=5 Participants	164.16 cm STANDARD_DEVIATION 8.750 • n=7 Participants	165.76 cm STANDARD_DEVIATION 7.202 • n=5 Participants	166.05 cm STANDARD_DEVIATION 6.859 • n=4 Participants	170.31 cm STANDARD_DEVIATION 10.502 • n=21 Participants	172.46 cm STANDARD_DEVIATION 8.654 • n=8 Participants	168.91 cm STANDARD_DEVIATION 167.75 • n=8 Participants
Weight	82.64 kg STANDARD_DEVIATION 15.560 • n=5 Participants	77.84 kg STANDARD_DEVIATION 13.175 • n=7 Participants	71.79 kg STANDARD_DEVIATION 10.707 • n=5 Participants	75.72 kg STANDARD_DEVIATION 17.332 • n=4 Participants	88.56 kg STANDARD_DEVIATION 15.208 • n=21 Participants	80.71 kg STANDARD_DEVIATION 13.984 • n=8 Participants	79.75 kg STANDARD_DEVIATION 14.532 • n=8 Participants
BMI	27.50 kg/m^2 STANDARD_DEVIATION 3.769 • n=5 Participants	28.75 kg/m^2 STANDARD_DEVIATION 3.418 • n=7 Participants	26.14 kg/m^2 STANDARD_DEVIATION 3.802 • n=5 Participants	27.25 kg/m^2 STANDARD_DEVIATION 4.533 • n=4 Participants	30.40 kg/m^2 STANDARD_DEVIATION 3.509 • n=21 Participants	27.04 kg/m^2 STANDARD_DEVIATION 3.971 • n=8 Participants	27.84 kg/m^2 STANDARD_DEVIATION 3.873 • n=8 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit	7 Participants	7 Participants	8 Participants	2 Participants	5 Participants	8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
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	3 participants	0 participants	0 participants	0 participants	1 participants
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	0 participants	0 participants	0 participants	0 participants	0 participants
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	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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	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 \[USP\]
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).	17356 ng/mL Interval 12366.4 to 22346.1	51909 ng/mL Interval 20138.2 to 83679.3	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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	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 \[USP\]
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).	1427.81 hours Interval 0.0 to 3894.799	3483.54 hours Interval 0.0 to 7177.138	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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	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 \[USP\]
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).	41021 hour(ug/mL) Interval 30100.6 to 51940.8	156745 hour(ug/mL) Interval 61880.0 to 251609.7	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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 \[USP\]
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). Monoclonal Antibody: Analyte 2130	20180 ng/mL Interval 12690.9 to 27669.3	12693 ng/mL Interval 8615.5 to 16771.1	27120 ng/mL Interval 20673.7 to 33567.2	—	—	—
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). Monoclonal Antibody: Analyte 2381	25478 ng/mL Interval 13996.0 to 36959.6	13812 ng/mL Interval 10415.4 to 17209.0	26049 ng/mL Interval 21916.8 to 30181.0	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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 \[USP\]
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). Monoclonal Antibody: Analyte 2130	1336.94 hours Interval 182.378 to 2491.497	371 hours Interval 84.22 to 659.507	654.15 hours Interval 0.0 to 1455.348	—	—	—
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). Monoclonal Antibody: Analyte 2381	1510.85 hours Interval 438.671 to 2583.029	371.86 hours Interval 84.22 to 659.507	741.06 hours Interval 0.0 to 1535.152	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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	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	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 \[USP\]
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). Monoclonal Antibody: Analyte 2130	50012 hour(ug/mL) Interval 22236.6 to 77788.1	25185 hour(ug/mL) Interval 12078.9 to 38290.8	71182 hour(ug/mL) Interval 34399.5 to 107965.4	—	—	—
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). Monoclonal Antibody: Analyte 2381	65725 hour(ug/mL) Interval 30277.7 to 101172.3	32594 hour(ug/mL) Interval 13117.2 to 52071.2	79138 hour(ug/mL) Interval 40378.4 to 117897.2	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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 \[USP\]
Presence of Anti-drug Antibody (ADA) Levels Pre-dose	2 participants	0 participants	0 participants	0 participants	1 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 15	1 participants	0 participants	0 participants	1 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 30	1 participants	0 participants	0 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 45	1 participants	0 participants	0 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 60	1 participants	0 participants	0 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 90	2 participants	0 participants	1 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 120	1 participants	0 participants	5 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 150	2 participants	4 participants	2 participants	0 participants	0 participants	—
Presence of Anti-drug Antibody (ADA) Levels Day 180	3 participants	3 participants	1 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 365 days

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 1-7 (1-15 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 8-9 (30-45 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 10 (60 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 11 (90 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 12 (120 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 13 (150 days)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 14 (180 days)	2 participants	1 participants	0 participants	0 participants	0 participants	0 participants
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing Visit 15 (365 days)	3 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 365 days

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 365 days

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Placebo n=10 Participants 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 \[USP\]
The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 Participants 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 Participants 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 Participants 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	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 \[USP\]
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Pre-dose	117.0 ng/mL below the level of detection	117.0 ng/mL below the level of detection	117.0 ng/mL below the level of detection	130.6 ng/mL Interval 98.5 to 173.1	1864.4 ng/mL Interval 937.8 to 3706.7	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 2	1840.8 ng/mL Interval 905.9 to 3740.4	1209.1 ng/mL Interval 635.4 to 2300.8	1113.9 ng/mL Interval 373.6 to 3320.9	470.6 ng/mL Interval 290.9 to 761.3	2469.4 ng/mL Interval 1342.8 to 4541.2	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 15	2917.7 ng/mL Interval 1945.0 to 4376.9	3135.1 ng/mL Interval 2079.3 to 4727.2	4340.8 ng/mL Interval 2880.1 to 6542.1	1759.7 ng/mL Interval 1346.7 to 2299.2	3593.4 ng/mL Interval 2249.8 to 5739.4	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 30	3024.5 ng/mL Interval 1839.6 to 4972.6	4835.5 ng/mL Interval 2367.3 to 9877.1	3135.1 ng/mL Interval 2394.3 to 4105.1	1613.5 ng/mL Interval 1327.1 to 1961.7	3020.3 ng/mL Interval 1695.6 to 5379.8	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 60	1149.1 ng/mL Interval 782.5 to 1687.4	3419.0 ng/mL Interval 2209.2 to 5291.2	2543.2 ng/mL Interval 1925.4 to 3359.3	1223.1 ng/mL Interval 600.0 to 2493.0	3135.2 ng/mL Interval 1716.5 to 5726.5	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 90	1748.3 ng/mL Interval 931.0 to 3283.2	2113.3 ng/mL Interval 918.7 to 4861.4	918.3 ng/mL Interval 500.4 to 1685.5	806.9 ng/mL Interval 487.2 to 1336.4	3692.0 ng/mL Interval 1609.8 to 8467.4	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 120	800.2 ng/mL Interval 415.5 to 1543.0	767.9 ng/mL Interval 436.9 to 1349.5	1510.1 ng/mL Interval 1039.5 to 2193.7	595.9 ng/mL Interval 348.2 to 1019.8	3450.7 ng/mL Interval 1507.1 to 7900.6	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 150	230.6 ng/mL Interval 155.4 to 342.2	1424.9 ng/mL Interval 640.1 to 3171.6	1108.9 ng/mL Interval 690.5 to 1780.8	554.4 ng/mL Interval 209.1 to 1469.7	2488.5 ng/mL Interval 1068.0 to 5798.6	—
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods Day 180	579.0 ng/mL Interval 339.1 to 988.4	690.5 ng/mL Interval 220.4 to 2163.4	784.2 ng/mL Interval 338.9 to 1814.6	421.3 ng/mL Interval 334.5 to 530.6	2173.8 ng/mL Interval 973.7 to 4852.7	—

Adverse Events

Cohort 1: 150 mg IM Injection of Active Drug or Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 2: 300 mg IM Injection of Active Drug or Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3: 300 mg IM Injection of Active Drug or Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 4: 300 mg IM Injection of Active Drug or Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 5: 600 mg IM Injection of Active Drug or Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 participants at risk 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Placebo n=10 participants at risk Subjects in the placebo group received normal saline. The placebo group consisted of 10 subjects pooled from Cohorts 1-5. Normal Saline: Normal saline, 0.9% Sodium chloride Injection, US Pharmacopeia \[USP\]
Blood and lymphatic system disorders Splenic infarction	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Gastrointestinal disorders Duodenal ulcer perforation	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Nervous system disorders Chronic Inflammatory Demyelinating polyradiculoneuropathy	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Renal and urinary disorders Renal infarct	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Vascular disorders Arterial Thrombosis	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Psychiatric disorders Alcoholism	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects

Other adverse events

Measure	Cohort 1: 150 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 2: 300 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 3: 300 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Cohort 4: 300 mg IM Injection of Active Drug or Placebo n=6 participants at risk 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	Cohort 5: 600 mg IM Injection of Active Drug or Placebo n=8 participants at risk 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	Placebo n=10 participants at risk Subjects in the placebo group received normal saline. The placebo group consisted of 10 subjects pooled from Cohorts 1-5. Normal Saline: Normal saline, 0.9% Sodium chloride Injection, US Pharmacopeia \[USP\]
Investigations Blood creatine phosphokinase increased	37.5% 3/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	30.0% 3/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Activate partial thromboplastin time prolonged	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Aspartate aminotransferase increased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	25.0% 2/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	20.0% 2/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood creatinine increased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Granulocyte count decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Haemoglobin decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Lymphocyte count increased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Mean cell haemoglobin concentration decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Mean platelet volume increased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Neutrophil count decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Protein urine present	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Red cell distribution width decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations White blood cell count decreased	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	16.7% 1/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood creatinine abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood pressure systolic abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood urea abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Nitrite urine present	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Red blood cell count abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Red blood cells urine positive	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Urine ketone body present	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Urine leukocyte esterase positive	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations White blood cell count increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Alanine aminotransferase increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Metabolism and nutrition disorders Alkalosis	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Renal and urinary disorders Cystitis noninfective	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	16.7% 1/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Neutrophil count increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Monocyte count increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations White blood cell count abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	12.5% 1/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Activate partial thromboplastin time abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	20.0% 2/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Prothrombin time prolonged	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	20.0% 2/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Alanine aminotransferase abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood bilirubin abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood bilirubin unconjugated decreased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood calcium increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood creatine phosphokinase abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood glucose increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Blood urea increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Renal and urinary disorders Chromaturia	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Renal and urinary disorders Proteinuria	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Haemoglobin increased	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
Investigations Neutrophil count abnormal	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/6 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	0.00% 0/8 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects	10.0% 1/10 • 540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects

Additional Information

Angie Kimbler

Resilience Government Services

Phone: 386-418-8751

Email: angie.kimbler@resilience.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place