A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorModeX Therapeutics, An OPKO Health Company
About this trial
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.
Eligibility criteria
Qualifiers
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.
Asthma
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MDX2301
- Normal Saline
- Normal Saline
- MDX2301
Treatment groups
80 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov