Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

Merck KGaA (EMD Serono)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: M5542; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577337

MS201491_0001A

2024-513069-37-00 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 49 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

M5542

Experimental group

Treatment:

Biological: M5542

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo