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

Completed · Phase 1 · Has a placebo group

Conditions studied: SARS-CoV-2

In brief

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.

Key facts

Study ID

NCT04592549

Run by

Alachua Government Services, Inc.

People needed

48

Starts

2020-12-04

Expected to finish

2023-10-06

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• Menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses.
• 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
• 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.
• 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
• Note: Prohibited medications include immunosuppressives (except Nonsteroidal Anti-Inflammatory Drugs [NSAIDS]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents
• Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety

Where it is running

• PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
• ICON Early Phase Services, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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