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

NCT04592549 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ADM03820-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• 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

Study Arms (5)

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

Drug: ADM03820; Other: 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.

Drug: ADM03820; Other: 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

Drug: ADM03820; Other: 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

Drug: ADM03820; Other: Placebo

Cohort 5: 600 mg IM injection of active drug or placebo

EXPERIMENTAL

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

Drug: ADM03820; Other: Placebo

Interventions

ADM03820 DRUG

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

Cohort 1: 150 mg IM injection of active drug or placebo; Cohort 2: 300 mg IM injection of active drug or placebo; Cohort 3: 300 mg IM injection of active drug or placebo; Cohort 4: 300 mg IM injection of active drug or placebo; Cohort 5: 600 mg IM injection of active drug or placebo

Placebo OTHER

Placebo

Cohort 1: 150 mg IM injection of active drug or placebo; Cohort 2: 300 mg IM injection of active drug or placebo; Cohort 3: 300 mg IM injection of active drug or placebo; Cohort 4: 300 mg IM injection of active drug or placebo; Cohort 5: 600 mg IM injection of active drug or placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• If urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein.
• Other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead
• Enabling Biotechnologies (EB): collaborator

Study Sites (2)

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Interventions

ADM03820

Results Point of Contact

• Title: Angie Kimbler
• Organization: Resilience Government Services

angie.kimbler@resilience.com

386-418-8751

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: December 4, 2020
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)