A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 55 years (Part A,B, and C)
- •BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ [height (m)]
排除标准
- •Any significant medical illness
- •Cannot tolerate subcutaneous injections, or having blood samples taken
- •Smoking more than 10 cigarettes/day
- •History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
- •HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
- •Pregnancy
研究组 & 干预措施
Part A: Single Ascending Dose (SAD)
BMS-986171 or Placebo on specified days
干预措施: BMS-986171 (Drug)
Part A: Single Ascending Dose (SAD)
BMS-986171 or Placebo on specified days
干预措施: Placebo (Other)
Part B: Multiple Ascending Dose (MAD)
BMS-986171 or Placebo on specified days
干预措施: BMS-986171 (Drug)
Part B: Multiple Ascending Dose (MAD)
BMS-986171 or Placebo on specified days
干预措施: Placebo (Other)
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)
BMS-986171 or Placebo on specified days
干预措施: BMS-986171 (Drug)
Part C: Multiple Ascending Dose in Japanese subjects (J-MAD)
BMS-986171 or Placebo on specified days
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
时间窗: up to 30 days after the last dose
Adverse Event (AE)
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
时间窗: up to 30 days after the last dose
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
时间窗: up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
时间窗: up to 30 days after the last dose
次要结局
- Immunogenicity based on antibody responses(6 months following study discharge.)