Actively Recruiting
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
Led by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Updated on 2026-04-27
49
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be overtly healthy based on medical evaluation, physical exam, and lab tests with no active significant disorder at screening and Day -1
- Body weight must be between 50 and 100 kilograms inclusive at screening
- Body mass index (BMI) must be between 18 and 30 kg/m² inclusive at screening
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- History or presence of clinically relevant diseases or disorders including respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric conditions, or epilepsy at screening and Day -1
- Any condition or screening finding that poses a risk or contraindication for participation or interferes with study objectives
- History of any malignancy
- History of chronic or recurrent infections or any bacterial, viral, parasitic, or fungal infection within 30 days prior to screening or hospitalization due to infection within 6 months prior to screening
- Immunization with any vaccine within 42 days prior to dosing or planned vaccination within 3 months after last study intervention
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Pharmacology Unit of Nuvisan GmbH
Neu-Ulm, Germany
Actively Recruiting
Research Team
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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