Single and Multiple Ascending Doses of M5542 Administered in Healthy Volunteers

Merck KGaA (EMD Serono)

Status and phase

Suspended

Phase 1

Conditions

Healthy

Treatments

Biological: Placebo

Biological: M5542

Study type

Interventional

Funder types

Industry

Identifiers

NCT06577337

MS201491_0001A

2024-513069-37-00 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

54 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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