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NCT07445971 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
A Phase 1 study of COVID-19 and COVID-19 (Prevention), sponsored by ModeX Therapeutics, An OPKO Health Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT07445971: Recruiting Phase 1 study of COVID-19 and COVID-19 (Prevention), sponsored by ModeX Therapeutics, An OPKO Health Company.
NCT07445971 is a Phase 1 study of COVID-19 and COVID-19 (Prevention) that is actively recruiting participants, run by ModeX Therapeutics, An OPKO Health Company. The registered enrollment target is 80 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07445971, a Phase 1 study of COVID-19 and COVID-19 (Prevention), is actively recruiting participants, sponsored by ModeX Therapeutics, An OPKO Health Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.
Conditions Studied
Interventions
- BIOLOGICAL MDX2301
- BIOLOGICAL Normal Saline
Study Locations (2)
Nevada
- TrialMed Clinical Research Unit - Las Vegas
Texas
- TrialMed Clinical Research Unit - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-03 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT07445971 shows while recruiting
NCT07445971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which MDX2301 is the first listed.
NCT07445971 reports a single indexed study location in Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT07445971 about?
NCT07445971 is a clinical study titled "A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.". 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. ...
What is the current status of trial NCT07445971?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2026-03. Estimated completion is 2027-12.
What conditions does trial NCT07445971 study?
This clinical trial studies the following conditions: COVID-19, COVID-19 (Prevention).
What interventions are being tested in trial NCT07445971?
The interventions under investigation include: MDX2301 (BIOLOGICAL), Normal Saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT07445971?
This trial is sponsored by ModeX Therapeutics, An OPKO Health Company, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07445971 being conducted?
This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07445971's enrollment target sits among peer trials
80 216th of 298 higher than 78 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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