NCT05638282已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年2月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be Chinese (both biological parents are ethnically Chinese).
- •Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m^2), inclusive. BMI = weight (kg)/[height (m)]^
- •Body weight ≥ 50.0 kg.
排除标准
- •History of clinically significant infection within 4 weeks of dosing on Day
- •Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- •Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cendakimab
Experimental
干预措施: Cendakimab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
时间窗: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
时间窗: Predose and at multiple timepoints (up to 105 days) after dosing
次要结局
- Number of Participants with Treatment-emergent Adverse Events(Day 1 through Day 105)
- Number of Participants with Clinically Significant Changes in Vital Signs(Screening (Days -28 to -1) through Day 105)
- Number of Participants with Clinically Significant Changes in Physical Examinations(Screening (Days -28 to -1) through Day 105)
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests(Screening (Days -28 to -1) through Day 105)
- Number of Participants with Clinically Significant Changes in Electrocardiograms(Screening (Days -28 to -1) through Day 105)
研究者
研究点 (1)
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