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Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
49
Start Date
2024-09-12
Completion Date
2027-03-09
Last Updated
2026-04-01
Healthy Volunteers
Yes
Conditions
Interventions
M5542
Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.
Placebo
Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.
Locations (1)
Clinical Pharmacology Unit of Nuvisan GmbH
Neu-Ulm, Germany