A Phase 1a/b Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19
ModeX Therapeutics, An OPKO Health Company
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Healthy Adults 1. Participant is a healthy male or female, 18 to 64 years of age. 2. Participant is in good health in the opinion of the investigator. Adults at Higher Risk for Developing Severe COVID-19: 3. Participant is a male or female, 18 to 64 years of age. 4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors: 1. Asthma 2. Diabetes 3. Cerebrovascular disease, which affects blood flow to the brain. 4. Chronic kidney disease 5. Chronic lung disease 6. Cardiac disease 7. Chronic liver dis…
Interventions
- BiologicalMDX2301
MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
- BiologicalNormal Saline
Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
- BiologicalNormal Saline
Placebo as intramuscular injection or subcutaneous injection.
- BiologicalMDX2301
MDX2301 as intramuscular injection or subcutaneous injection.
Locations (2)
- TrialMed Clinical Research UnitLas Vegas, Nevada
- TrialMed Clinical Research UnitAustin, Texas