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Recruiting NCT06577337

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: M5542, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Day 85]
  • Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs [Time frame: Up to Day 85]
Secondary outcome measures (2)
  • Pharmacokinetic (PK) Serum Concentrations of M5542 [Time frame: Pre-dose up to 1344 hours post-dose]
  • Number of Participants with Anti-Drug Antibodies (ADA) Against M5542 [Time frame: Pre-dose up to Day 57]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Other

Study locations

Germany · 1 center
  • Clinical Pharmacology Unit of Nuvisan GmbH — Neu-Ulm

Identifiers

NCT: NCT06577337 · MS201491_0001A · 2024-513069-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗