NCT06577337招募中1 期
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 人开始时间: 2024年9月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 live vaccine for 12 weeks and subunit or inactivated vaccines for 2 weeks prior to dosing on Day
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
M5542
Experimental
干预措施: M5542 (Biological)
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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's DiseaseCrohns DiseaseHealthy SubjectsNCT05452304AstraZeneca112
已完成
1 期
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult ParticipantsHealthy VolunteerNCT03943056Biogen64
已完成
1 期
A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on MethotrexatePharmacokinetics of ASP2409Rheumatoid ArthritisNCT02171143Astellas Pharma Global Development, Inc.58
已完成
1 期
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult VolunteersHealthyNCT06334211Foresee Pharmaceuticals Co., Ltd.64
已完成
1 期
Safety, Tolerability & PK of AZD0328 in Caucasian & JapaneseHealthy VolunteersNCT00738959AstraZeneca64