Status:
SUSPENDED
Single and Multiple Ascending Doses of M5542 Administered in Healthy Volunteers
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06577337
Start Date
September 12 2024
End Date
March 31 2028
Last Update
September 10 2025
Active Locations (1)
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1
Clinical Pharmacology Unit of Nuvisan GmbH
Neu-Ulm, Germany