Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Half Life (T-HALF)
研究概览
简要总结
The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy, males and females, 18 to 55 years of age, inclusive
- •Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
- •Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug
排除标准
- •Any significant acute or chronic medical illness
- •History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder
- •History of autoimmune disease
- •Any known skin condition that would affect subcutaneous dosing
- •Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986189
Specified Dose on Specified Day
干预措施: BMS-986189 (Drug)
Placebo
Specified Dose on Specified Day
干预措施: Placebo (Other)
结局指标
主要结局
Half Life (T-HALF)
时间窗: Day 1 to Day 30
Apparent volume of distribution at steady state (Vss/F)
时间窗: Day 1 to Day 30
Lab abnormalities leading to discontinuation
时间窗: Day 1 to Day 30
Total Body Clearance (CLT/F)
时间窗: Day 1 to Day 30
Deaths leading to discontinuation
时间窗: Day 1 to Day 30
Maximum observed concentration (Cmax)
时间窗: Day 1 to Day 30
Time of maximum observed concentration (Tmax)
时间窗: Day 1 to Day 30
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T))
时间窗: Day 1 to Day 30
Serious adverse events (SAEs) leading to discontinuation
时间窗: Day 1 to Day 30
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Day 1 to Day 30
Adverse events (AEs) leading to discontinuation
时间窗: Day 1 to Day 30
次要结局
未报告次要终点