Actively Recruiting
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
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
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, immune response, pharmacokinetics, and pharmacodynamics of single ascending doses of M5542 administered under the skin in healthy adult volunteers. This early-phase trial aims to gather important information about how the body handles M5542 and how the immune system reacts to it. Participants will receive a single dose of either M5542 or a matching placebo by subcutaneous injection on the first day of the study. The doses will increase in a stepwise fashion across groups to assess different levels. The study design includes randomized assignment and quadruple masking to ensure unbiased results. During the study, participants will be monitored up to 85 days for any treatment-related adverse events, abnormal lab tests, heart function via ECG, and vital signs. Blood samples will be collected at various times up to about 56 days after dosing to measure drug levels and check for antibodies against M5542. Overall participation lasts several weeks with close safety and immune response monitoring throughout.
CONDITIONS
Brief Title
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants are overtly healthy with no active clinically significant disorder or disease at screening and Day -1
- Body weight between 50 and 100 kilograms at screening
- Body mass index (BMI) between 18 and 30 kg/m² 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, epilepsy at screening and Day -1
- Any condition or screening finding that poses risk or interferes with study participation
- History of any malignancy
- History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to screening
- Hospitalization due to infection within 6 months prior to screening
- Immunization with any vaccine 42 days before dosing or planned within 3 months after last study intervention
- Other protocol defined exclusion criteria may apply
Research Team
C
Communication Center
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