A Phase 1 interventional study of M5542 and Placebo in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Other
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.
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: M5542
Biological: Placebo
Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.
Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 85
Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Time frame: Up to Day 85
Pharmacokinetic (PK) Serum Concentrations of M5542
Time frame: Pre-dose up to 1344 hours post-dose
Number of Participants with Anti-Drug Antibodies (ADA) Against M5542
Time frame: Pre-dose up to Day 57
Plan to share: No — IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany