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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to Day 85]
• Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs [Срок оценки: Up to Day 85]

Вторичные конечные точки (2)

• Pharmacokinetic (PK) Serum Concentrations of M5542 [Срок оценки: Pre-dose up to 1344 hours post-dose]
• Number of Participants with Anti-Drug Antibodies (ADA) Against M5542 [Срок оценки: Pre-dose up to Day 57]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• Clinical Pharmacology Unit of Nuvisan GmbH — Neu-Ulm

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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