Phase 1ab Study to Evaluate the Safety and Effects of MDX2301 in Adults 18 to 64 Years, Including Those at Higher Risk for Severe COVID-19, Using IV, IM, or SC Administration

What this Trial Is About

Researchers are evaluating MDX2301, a biological drug administered by intravenous, intramuscular, or subcutaneous routes, in healthy adults and adults at higher risk for severe COVID-19. This phase 1ab randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, anti-drug antibody response, and virus neutralizing activity of MDX2301. The study includes adults aged 18 to 64 years and explores different administration routes and dosing schedules to better understand how the drug behaves in the body and its immune effects. Participants will be assigned to receive either MDX2301 or placebo through various routes healthy adults may receive a single dose via intravenous infusion, intramuscular injection, or subcutaneous injection, or a repeat intramuscular or subcutaneous dose about three months apart. Adults at higher risk for severe COVID-19 will receive a single intramuscular or subcutaneous dose of MDX2301 or placebo. The study uses a randomized, quadruple-masked design to compare these groups and monitor responses over time. Throughout the study, participants will be monitored for adverse events from baseline up to approximately 12 months. Blood samples will be collected to measure drug concentration over time, half-life, volume of distribution, and presence of anti-drug antibodies. Researchers will also evaluate the virus neutralizing antibodies in participants serum. Regular visits and assessments will ensure participant safety and collect data on how MDX2301 is processed by the body and its immune effects during the study period.

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.