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

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

Interventions

• Biological
  MDX2301

  MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.

• Biological
  Normal Saline

  Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.

• Biological
  Normal Saline

  Placebo as intramuscular injection or subcutaneous injection.

• Biological
  MDX2301

  MDX2301 as intramuscular injection or subcutaneous injection.

Locations (2)