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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany1 个研究点分布在 1 个国家目标入组 49 人2024年9月12日

适应症Healthy

干预措施M5542 Placebo

概览

阶段: 1 期
干预措施: M5542
疾病 / 适应症: Healthy
发起方: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
入组人数: 49
试验地点: 1
主要终点: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
状态: 招募中
最后更新: 5天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年9月12日

结束日期

2027年3月9日

最后更新

5天前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

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

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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

研究组 & 干预措施

M5542

干预措施: M5542

Placebo

干预措施: Placebo

结局指标

主要结局

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

时间窗: Up to Day 85

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

时间窗: Up to Day 85

次要结局

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)