Single and Multiple Ascending Doses of M5542 Administered in Healthy Volunteers
- Registration Number
- NCT06577337
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
The study will evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of M5542 in healthy participants. This study will be conducted in 2 parts: Part A (SAD) and Part B (MAD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Participants are overtly healthy, as determined by medical evaluation, by physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion at Screening and Day -1
- Participants have a body weight within the range 50 to 100 kilograms (kg) (inclusive) and body mass index (BMI) within the range 18 to 30.0 kilograms per square meter kg/m^2 (inclusive) at Screening
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric and other diseases or disorders, and epilepsy, as determined by medical evaluation at Screening and Day -1
- Any condition, including findings in the laboratory tests or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation at Screening and on Day -1
- 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 and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
- Immunization with any vaccine 42 days prior to dosing on Day 1 or planned within 3 months after the last administration of study intervention
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A and Part B: Placebo Placebo - Part A and Part B: M5542 M5542 -
- Primary Outcome Measures
Name Time Method Part B: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs Up to Day 113 Part A: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Up to Day 85 Part B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Up to Day 113 Part A: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs Up to Day 85
- Secondary Outcome Measures
Name Time Method Part A and Part B: Pharmacokinetic (PK) Serum Concentrations of M5542 Part A: Pre-dose up to 1344 hours post-dose; Part B: Pre-dose up to 2688 hours post-dose Part A and B: Number of Participants with Anti-Drug Antibodies (ADA) Against M5542 Part A: Pre-dose up to Day 57; Part B: Pre-dose up to Day 113
Trial Locations
- Locations (1)
Clinical Pharmacology Unit of Nuvisan GmbH
🇩🇪Neu-Ulm, Germany