NCT05517837终止早期 1 期
A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年9月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 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 and tolerability of BMS-986421 in healthy adult 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
- Double (Participant, 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 are required to remain in the clinical facility from Day -1 (Part 1) or Day -2 (Part 2) until clinic discharge.
- •A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
- •All female participants, Women of Childbearing Potential (WOCBP) and women not of childbearing potential, must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) at screening and on Day -1 (or Day -2 for Part 2).
排除标准
- •Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- •Vaccination or plans for vaccination with non-live vaccines within 30 days before Day -1 (for Day -2 for Part 2) until the follow-up phone call.
- •Donation of blood or blood transfusion within 8 weeks of first study intervention administration.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
BMS-986421 Under Fasted Conditions
Experimental
干预措施: BMS-986421 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 8 Weeks
Number of participants with clinical laboratory abnormalities
时间窗: Up to 8 Weeks
Number of participants with physical examination abnormalities
时间窗: Up to 8 Weeks
Number of participants with vital sign abnormalities
时间窗: Up to 8 Weeks
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 8 Weeks
次要结局
- Maximum observed plasma concentration (Cmax)(Up to 192 hours after each dose)
- Area under the plasma concentration-time curve from time zero to time last quantifiable concentration (AUC[0-T])(Up to 192 hours after each dose)
- Time of maximum observed plasma concentration (Tmax)(Up to 192 hours after each dose)
研究者
研究点 (1)
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