Clinical Trial

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-25; most recent amendment 2026-05-15.
Status change: Not Yet Recruiting → Recruiting 2026-03-02
Trial Details
NCT Number NCT07445971
Lead Sponsor ModeX Therapeutics, An OPKO Health Company
Conditions COVID -19, COVID-19 (Prevention)
Enrollment 80 participants
Start Date 2026-03-24
Primary Completion 2027-09 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-18