NCT05760937已完成1 期
A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious AEs (SAEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive.
- •Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
- •A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.
排除标准
- •Participant has any condition that confounds the ability to interpret data from the study.
- •Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
- •Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986447
Experimental
干预措施: BMS-986447 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Serious AEs (SAEs)
时间窗: Up to 59 days
Number of Participants with Adverse Events (AEs)
时间窗: Up to 59 days
Number of Participants with Vital Sign Abnormalities
时间窗: Up to 35 days
Number of Participants with Clinical Laboratory Abnormalities
时间窗: Up to 34 days
Number of Participants with Physical Examination Abnormalities
时间窗: Up to 35 days
Number of Participants with Electrocardiogram (ECG) Abnormalities
时间窗: Up to 34 days
次要结局
- Maximum observed plasma concentration (Cmax)(Up to 72 hours postdose)
- Time of maximum observed plasma concentration (Tmax)(Up to 72 hours postdose)
- Apparent terminal phase half-life (T-Half)(Up to 72 hours postdose)
研究者
研究点 (1)
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