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NCT Number: NCT06577337

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit of Nuvisan GmbH

Neu-Ulm, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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
  • Other protocol defined exclusion criteria could apply

Treatment and study plan

M5542

Biological

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

Placebo

Biological

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

Primary outcomes

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

    Time frame: Up to Day 85

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

    Time frame: Up to Day 85

Secondary outcomes

  1. Pharmacokinetic (PK) Serum Concentrations of M5542

    Time frame: Pre-dose up to 1344 hours post-dose

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

    Time frame: Pre-dose up to Day 57

Study contacts

Contact information is provided by the study sponsor or research team.

Communication Center

CONTACT

[email protected]

+49 6151 72 5200

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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