NCT07445971

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ModeX Therapeutics, An OPKO Health Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID -19
• COVID-19 (Prevention)

Interventions

Type	Name	Description
BIOLOGICAL	MDX2301	MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
BIOLOGICAL	Normal Saline	Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
BIOLOGICAL	Normal Saline	Placebo as intramuscular injection or subcutaneous injection.
BIOLOGICAL	MDX2301	MDX2301 as intramuscular injection or subcutaneous injection.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2026-03-03
• Last updated: 2026-03-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study