NCT07422207

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

A Phase 1, First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Meiji Pharma USA Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ME3241	Part 1 (single ascending dose): Participants will receive a single infusion of ME3241. Part 2 (multiple ascending dose): Participants will receive multiple infusions of ME3241. Part 3 (single dose for Japanese participants): Japanese participants will receive a single infusion of ME3241.
OTHER	Placebo	Part 1 (single ascending dose): Participants will receive a single infusion of placebo. Part 2 (multiple ascending dose): Participants will receive multiple infusions of placebo. Part 3 (single dose for Japanese participants): Japanese participants will receive a single infusion of placebo.

Timeline

• Start date: 2026-03-23
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-02-19
• Last updated: 2026-04-06

Locations

1 site across 1 country: Australia