NCT05806359已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年3月31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
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
- •Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
- •Caucasian participants must be of European or Latin American Caucasian descent.
- •A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
- •Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.
排除标准
- •Any acute or chronic medical illness.
- •Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
- •History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Japanese Cohort - Dose 1
Experimental
干预措施: Danicamtiv (Drug)
Japanese Cohort - Dose 1
Experimental
干预措施: Placebo (Drug)
Japanese Cohort - Dose 2
Experimental
干预措施: Danicamtiv (Drug)
Japanese Cohort - Dose 2
Experimental
干预措施: Placebo (Drug)
Japanese Cohort - Dose 3
Experimental
干预措施: Danicamtiv (Drug)
Japanese Cohort - Dose 3
Experimental
干预措施: Placebo (Drug)
Caucasian Cohort - Dose 3
Experimental
干预措施: Danicamtiv (Drug)
Caucasian Cohort - Dose 3
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Day 1 up to Day 28
Number of Participants with Vital Sign Abnormalities
时间窗: Day 1 up to Day 7
Number of Participants with Electrocardiogram (ECG) Abnormalities
时间窗: Day 1 up to Day 7
Number of Participants with Physical Examination Abnormalities
时间窗: Day 1 up to Day 7
Number of Participants with Clinical Laboratory Abnormalities
时间窗: Day 1 up to Day 7
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Predose and at multiple timepoints (Day 1 up to Day 6) after dosing)
- Time of Maximum Observed Plasma Concentration (Tmax)(Predose and at multiple timepoints (Day 1 up to Day 6) after dosing)
- Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)](Predose and at multiple timepoints (Day 1 up to Day 6) after dosing)
研究者
研究点 (1)
Loading locations...
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