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

Conditions

• COVID -19
• COVID-19 (Prevention)

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• MDX2301 — BIOLOGICAL
  MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
• Normal Saline — BIOLOGICAL
  Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
• Normal Saline — BIOLOGICAL
  Placebo as intramuscular injection or subcutaneous injection.
• MDX2301 — BIOLOGICAL
  MDX2301 as intramuscular injection or subcutaneous injection.

Study Details

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.

Key Dates

Start date

Mar 24, 2026

Status verified

May 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Single Dose Healthy Adults MDX2301
  Healthy Adults will receive a single dose of MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
• Placebo Comparator: Single Dose Healthy Adults Placebo
  Healthy Adults will receive a single dose of placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
• Experimental: Repeat Dose Healthy Adults MDX2301
  Healthy Adults will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection and then receive a repeat dose of MDX2301, 3 months later as intramuscular injection or subcutaneous injection.
• Placebo Comparator: Repeat Dose Healthy Adults Placebo
  Healthy Adults will receive a single dose of placebo as intramuscular injection or subcutaneous injection and then receive a repeat dose of placebo 3 months later as intramuscular injection or subcutaneous injection.
• Experimental: Single-Dose Higher Risk Adults MDX2301
  Adults at higher risk for severe COVID-19 will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection.
• Placebo Comparator: Single-Dose Higher Risk Adults Placebo
  Adults at higher risk for severe COVID-19 will receive a single dose of placebo as intramuscular injection or subcutaneous injection.

Primary Outcome Measure

Adverse Events [ Time Frame: Baseline until end of study, up to approximately 12 months ]

Central Contacts

• ModeX Therapeutics, An OPKO Health Company
  857-233-9936
  [email protected]

Locations (2)

Find similar trials in Las Vegas, NV

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