A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19. (NCT07445971) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
United States80 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Participant is a healthy male or female, 18 to 64 years of age.
✓. Participant is in good health in the opinion of the investigator.
✓. Participant is a male or female, 18 to 64 years of age.
✓. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:
✓. Asthma
✓. Diabetes
✓. Cerebrovascular disease, which affects blood flow to the brain.
✓. Chronic kidney disease
Exclusion criteria
✕. Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.
✕. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.
✕. Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.
✕. Participant has evidence of active hepatitis B or hepatitis C infections at screening.
What they're measuring
1
Adverse Events
Timeframe: Baseline until end of study, up to approximately 12 months