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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 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 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07445971
The ClinicalTrials.gov registry entry for NCT07445971 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is ModeX Therapeutics, An OPKO Health Company, which has 2 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.