Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-08-28; most recent amendment 2026-07-06.
Status change: Suspended → Recruiting 2026-02-02
Status change: Recruiting → Suspended 2025-01-13
Status change: Not Yet Recruiting → Recruiting 2024-10-02
Trial Details
NCT Number NCT06577337
Lead Sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Healthy
Enrollment 49 participants
Start Date 2024-09-12
Primary Completion 2026-11-16 (estimated)
Study Completion 2027-03-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-08