Study of MDX2301 for COVID-19 Prevention and Treatment

This study is testing a new treatment called MDX2301 in healthy adults and adults who are at higher risk for severe COVID-19. Researchers want to see how safe MDX2301 is, how well your body tolerates it, and how it moves through your system. You would receive MDX2301 or a placebo (like normal saline, which has no active medicine) through an IV (intravenous infusion, into a vein), IM (intramuscular injection, into a muscle), or SC (subcutaneous injection, under the skin). Some participants will receive a single dose, and others will receive a second dose about three months later. The study will track any side effects for up to approximately 12 months.

Study design
This interventional study plans to enroll 80 participants. It is a first-in-human study, meaning it's the first time MDX2301 is being tested in people.
What's involved
Participants will receive single doses of MDX2301 or placebo, and some will receive a repeat dose approximately 3 months later. The study will monitor you for up to approximately 12 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events (side effects) from the start of the study until its end, which is up to approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07445971

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

Recruiting
PHASE1Ages 18–64InterventionalPrevention
ModeX Therapeutics, An OPKO Health Company
~80 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:MDX2301Normal Saline

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over Baseline until end of study, up to approximately 12 months
COVID -19
COVID-19 (Prevention)
2 sites across 2 states
Nevada1
Texas1
  • Trial Med · PRINCIPAL_INVESTIGATOR · TrialMed
ModeX Therapeutics, An OPKO Health Company
Email the study team

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  • Adverse EventsBaseline until end of study, up to approximately 12 months

    Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.