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| Name | Class |
|---|---|
| Enabling Biotechnologies (EB) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 150 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 1 will receive a 150 mg dose IM injection of either active drug or placebo. Cohort 1 will dose 8 subjects to active drug and 2 subject to placebo |
|
| Cohort 2: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 2 will receive 300 mg IM injection of either active drug or placebo. Cohort 2 will dose 8 subjects to active drug and 2 subject to placebo. |
|
| Cohort 3: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 3 will receive 300 mg IM injection of either active drug or placebo. Cohort 3 will dose 8 subjects to active drug and 2 subject to placebo |
|
| Cohort 4: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 4 will receive 300 mg IM injection of either active drug or placebo. Cohort 4 will dose 8 subjects to active drug and 2 subject to placebo |
|
| Cohort 5: 600 mg IM injection of active drug or placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADM03820 | Drug | ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo |
| The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit | Determine the number of AEs after dosing | 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for 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 | 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. | 540 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Informed consent understood and signed
Healthy male or healthy, non-pregnant, non-lactating female
Willingness to comply and be available for all protocol procedures for the duration of the study
Between the ages of 18 and 55, inclusive on the day of dosing
Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
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.
Females of childbearing potential and males agree to use acceptable contraception for the duration of the study
Screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the Principal Investigator
The urine drug screen is negative
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.
Agree to minimize risk of SARS-CoV-2 infection.
Exclusion Criteria:
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.
Subjects with cardiovascular disease
Subjects with diabetes
Subjects with pulmonary diseases such as COPD or asthma
History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins.
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds)
Clinically significant abnormal electrocardiogram at screening.
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
Positive serology results for HIV, HBsAg, or HCV antibodies
Febrile illness with temperature ≥38°C within 7 days of dosing
Female subject who is pregnant or breastfeeding
Donated blood within 56 days of enrollment
Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
Treatment with another investigational drug within 28 days of dosing
Treatment with a monoclonal antibody within 3 months of enrollment
Positive serology results for SARS-CoV-2 antibodies (Not applicable for Cohort 5).
Positive results from a reverse transcriptase polymerase chain reaction (RT PCR) test for SARS CoV 2
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
Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Use of H1 antihistamines or beta-blockers within 5 days of dosing
Use of any prohibited medication within 28 days prior to screening or planned use during the study period
Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
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
Is a study site employee or staff
Received an approved COVID-19 vaccine (subjects can receive an approved COVID-19 vaccine after completing their Day 90 visit). For Cohort 5, subjects who received a COVID-19 vaccine within 14 days prior to enrollment are excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States | ||
| ICON Early Phase Services, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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] |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo |
|
540 days for Cohorts 1-4, including placebo subjects and 365 days for Cohort 5, including placebo subjects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenic infarction | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angie Kimbler | Resilience Government Services | 386-418-8751 | angie.kimbler@resilience.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | Nov 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2023 | Nov 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000720461 | ADM03820 |
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Subjects in cohort 5 will receive 600 mg IM injection of either active drug or placebo. Cohort 5 will dose 8 subjects to active drug and 2 subject to placebo |
|
| Placebo | Other | Placebo |
|
| 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 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 |
| Presence of Anti-drug Antibody (ADA) Levels | This outcome looks at the total number of participants who had ADA levels at each time point | pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180 |
| 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 |
| San Antonio |
| Texas |
| 78209 |
| United States |
| Lost to Follow-up |
|
| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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] |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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] |
|
|
| Primary | The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit | Determine the number of AEs after dosing | Posted | Count of Participants | Participants | 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo |
|
|
|
| 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. | Posted | Number | participants | 540 days |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | ng/mL | 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 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | hours | 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 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | hour(ug/mL) | 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 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | ng/mL | 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 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | hours | 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 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | hour(ug/mL) | 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 |
|
|
|
| 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 | Posted | Number | participants | pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180 |
|
|
|
| Secondary | The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing | Posted | Number | participants | 365 days |
|
|
|
| Secondary | The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing | Posted | Number | participants | 365 days |
|
|
|
| Secondary | The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing | Posted | Number | participants | 365 days |
|
|
|
| Secondary | The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 180 days |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 7 |
| 8 |
| EG001 | 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 | 0 | 8 | 1 | 8 | 7 | 8 |
| EG002 | 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 | 0 | 8 | 0 | 8 | 8 | 8 |
| EG003 | 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 | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | 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 | 0 | 8 | 0 | 8 | 5 | 8 |
| EG005 | Placebo | 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] | 0 | 10 | 0 | 10 | 8 | 10 |
| Duodenal ulcer perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Chronic Inflammatory Demyelinating polyradiculoneuropathy | Nervous system disorders | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | Systematic Assessment |
|
| Arterial Thrombosis | Vascular disorders | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | Non-systematic Assessment |
|
| Activate partial thromboplastin time prolonged | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Granulocyte count decreased | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | Systematic Assessment |
|
| Mean cell haemoglobin concentration decreased | Investigations | Systematic Assessment |
|
| Mean platelet volume increased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Red cell distribution width decreased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood creatinine abnormal | Investigations | Systematic Assessment |
|
| Blood pressure systolic abnormal | Investigations | Systematic Assessment |
|
| Blood urea abnormal | Investigations | Systematic Assessment |
|
| Nitrite urine present | Investigations | Systematic Assessment |
|
| Red blood cell count abnormal | Investigations | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | Systematic Assessment |
|
| Urine ketone body present | Investigations | Systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Neutrophil count increased | Investigations | Systematic Assessment |
|
| Monocyte count increased | Investigations | Systematic Assessment |
|
| White blood cell count abnormal | Investigations | Systematic Assessment |
|
| Activate partial thromboplastin time abnormal | Investigations | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | Systematic Assessment |
|
| Alanine aminotransferase abnormal | Investigations | Systematic Assessment |
|
| Blood bilirubin abnormal | Investigations | Systematic Assessment |
|
| Blood bilirubin unconjugated decreased | Investigations | Systematic Assessment |
|
| Blood calcium increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase abnormal | Investigations | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Blood urea increased | Investigations | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Haemoglobin increased | Investigations | Systematic Assessment |
|
| Neutrophil count abnormal | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
Not provided
Not provided
| Changes from baseline in vital signs |
|
| Changes from baseline in clinical safety laboratory values |
|
| Monoclonal Antibody: Analyte 2381 |
|
| Monoclonal Antibody: Analyte 2381 |
|
| Monoclonal Antibody: Analyte 2381 |
|
| Day 15 |
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| Day 30 |
|
| Day 45 |
|
| Day 60 |
|
| Day 90 |
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| Day 120 |
|
| Day 150 |
|
| Day 180 |
|
| Visit 8-9 (30-45 days) |
|
| Visit 10 (60 days) |
|
| Visit 11 (90 days) |
|
| Visit 12 (120 days) |
|
| Visit 13 (150 days) |
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| Visit 14 (180 days) |
|
| Visit 15 (365 days) |
|
| Day 2 |
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| Day 15 |
|
| Day 30 |
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| Day 60 |
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| Day 90 |
|
| Day 120 |
|
| Day 150 |
|
| Day 180 |
|