MedTrace Logo

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

NCT07445971 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ModeX Therapeutics, An OPKO Health Company

    lead INDUSTRY

Principal Investigators

  • Trial Med · TrialMed

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07445971 on ClinicalTrials.gov