NCT06086886已完成1 期
A Phase 1, Double-blinded, Randomized, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986454 in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年11月16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
- 63
- 试验地点
- 2
- 主要终点
- Number of participants with clinical laboratory abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of BMS-986454 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
- 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
- •Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period.
- •Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- •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.
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
- •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).
- •Inability to be venipunctured or tolerate venous access.
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986454
Experimental
干预措施: BMS-986454 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with clinical laboratory abnormalities
时间窗: Up to approximately 4 months
Number of participants with vital sign abnormalities
时间窗: Up to approximately 4 months
Number of participants with adverse events (AEs)
时间窗: Up to approximately 4 months
Number of participants with severe adverse events (SAEs)
时间窗: Up to approximately 4 months
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to approximately 4 months
Number of participants with physical examination abnormalities
时间窗: Up to approximately 4 months
次要结局
- Maximum observed serum concentration (Cmax)(Up to approximately 3 months)
- Time of maximum observed serum concentration (Tmax)(Up to approximately 3 months)
- Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)](Up to approximately 3 months)
- Incidence of anti-drug antibody (ADA) formation(Up to approximately 3 months)
- Absolute Bioavailability (F) of BMS-986454(Up to approximately 3 months)
研究者
研究点 (2)
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