NCT04592549

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	ADM03820	ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-12-04
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2020-10-19
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study