A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults
Overview
- Phase
- Phase 1
- Intervention
- ADM03820
- Conditions
- SARS-CoV-2
- Sponsor
- Resilience Government Services, Inc.
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.
Detailed Description
The primary objective of this study is to assess the safety and tolerability of escalating IM doses of ADM03820 in healthy adults. Secondary objectives include assessing the pharmacokinetic characteristics and immunogenicity.
Investigators
Eligibility Criteria
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.
- •Note: A woman is considered of childbearing potential unless post-menopausal (\> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy
- •Females of childbearing potential and males agree to use acceptable contraception for the duration of the study
- •Note: These include progestin implants, intrauterine devices (IUDs), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. Use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the Ology Bioservices MM. All males will be required to use a barrier method (condoms) for the duration of the study
- •Screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the Principal Investigator
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.
- •Note: Clinically significant abnormal ECG results include but not limited to:
- •complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator
- •Incomplete right bundle branch block is not exclusionary if there are no abnormal ECG findings and there is no clinical history or evidence on physical examination to indicate cardiac disease.
Arms & Interventions
Cohort 1: 150 mg IM injection of active drug or placebo
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
Intervention: ADM03820
Cohort 1: 150 mg IM injection of active drug or placebo
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
Intervention: Placebo
Cohort 2: 300 mg IM injection of active drug or placebo
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.
Intervention: ADM03820
Cohort 2: 300 mg IM injection of active drug or placebo
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.
Intervention: Placebo
Cohort 3: 300 mg IM injection of active drug or placebo
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
Intervention: ADM03820
Cohort 3: 300 mg IM injection of active drug or placebo
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
Intervention: Placebo
Cohort 4: 300 mg IM injection of active drug or placebo
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
Intervention: ADM03820
Cohort 4: 300 mg IM injection of active drug or placebo
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
Intervention: Placebo
Cohort 5: 600 mg IM injection of active drug or placebo
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
Intervention: ADM03820
Cohort 5: 600 mg IM injection of active drug or placebo
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
Intervention: Placebo
Outcomes
Primary Outcomes
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit
Time Frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
Determine number of SAEs after dosing through the final visit
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit
Time Frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
Determine the number of AEs after dosing
The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit
Time Frame: 540 days
The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.
Secondary Outcomes
- The Assessment of Peak Plasma Concentration (Cmax) for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).(pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365)
- The Assessment of Tmax for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).(pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365)
- 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(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)