NCT06577337

Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics(PD) of single ascending doses (SAD) of subcutaneously administered M5542.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	M5542	Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.
BIOLOGICAL	Placebo	Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

Timeline

• Start date: 2024-09-12
• Primary completion: 2026-11-18
• Completion: 2027-03-09
• First posted: 2024-08-29
• Last updated: 2026-04-01

Locations

1 site across 1 country: Germany