NCT06084598已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenously Administered BMS-986446 in Healthy Participants Including Healthy Participants of Japanese Ethnicity
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年10月12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
- 24
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel
- •No limitations on ethnicity apply to Part 2, Panel 1
- •Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
- •Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening
- •Body weight between 45 kg and 110 kg
排除标准
- •Any clinically significant deviation from normal, as judged by the investigator
- •Any major surgery within 90 days of study drug administration
- •Participation in another interventional clinical trial concurrent with this study
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986446
Experimental
干预措施: BMS-986446 (Drug)
Placebo
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to Day 85
Number of participants with vital sign abnormalities
时间窗: Up to Day 85
Number of participants with body weight abnormalities
时间窗: Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to Day 85
Number of participants with physical examination abnormalities
时间窗: Up to Day 85
Number of participants with clinical laboratory abnormalities
时间窗: Up to Day 85
次要结局
- Maximum observed plasma concentration (Cmax)(Up to Day 85)
- Number of participants with anti-drug antibody (ADA)(Up to Day 85)
- Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)](Up to Day 85)
- Geometric mean ratios of Cmax(Up to Day 85)
- Time of maximum observed plasma concentration (Tmax)(Up to Day 85)
- Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)](Up to Day 85)
- Geometric mean ratios of [AUC(0-T)](Up to Day 85)
研究者
研究点 (1)
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