A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
A Phase 1a/b Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19
ModeX Therapeutics, An OPKO Health Company
80 participants
Mar 24, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
Placebo as intramuscular injection or subcutaneous injection.
MDX2301 as intramuscular injection or subcutaneous injection.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07445971