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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
ICON Early Phase Services, LLC
San Antonio, Texas, United States
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit
Determine number of SAEs after dosing through the final visit
Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit
Determine the number of AEs after dosing
Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit
The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.
Time frame: 540 days
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).
Time frame: 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).
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 365 days
The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing
Time frame: 365 days
The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing
Time frame: 365 days
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods
Time frame: 180 days