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

NCT06577337 | Recruiting Phase 1 DMC

• 2 other identifiers: MS201491_0001A2024-513069-37-00
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

First-in-Human

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 85

• Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs

  Up to Day 85

Secondary Outcomes (2)

• Pharmacokinetic (PK) Serum Concentrations of M5542

  Pre-dose up to 1344 hours post-dose

• Number of Participants with Anti-Drug Antibodies (ADA) Against M5542

  Pre-dose up to Day 57

Study Arms (2)

M5542

EXPERIMENTAL

Biological: M5542

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

Placebo

M5542 BIOLOGICAL

Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.

M5542

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 live vaccine for 12 weeks and subunit or inactivated vaccines for 2 weeks prior to dosing on Day 1. For the herpes zoster vaccine (e.g. Shingrix), if the first dose is administered at least 2 weeks prior to Day 1, the second dose must be administered after the study treatment period has been completed

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Clinical Pharmacology Unit of Nuvisan GmbH

Neu-Ulm, Germany

RECRUITING

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Central Study Contacts

Communication Center

CONTACT

+49 6151 72 5200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 29, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): March 18, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)