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临床试验/NCT04008992
NCT04008992已完成1 期

A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.

Bristol-Myers Squibb2 个研究点 分布在 2 个国家目标入组 132 人开始时间: 2019年6月18日最近更新:
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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
132
试验地点
2
主要终点
Incidence of Adverse Events (AEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
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

  • •Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^
  • •Males and females not of child bearing potential.
  • •Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)

排除标准

  • •Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.
  • •Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.
  • •Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease

研究组 & 干预措施

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

干预措施: Iohexol (Diagnostic Test)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

干预措施: BMS-986259 (Drug)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

干预措施: Placebo (Other)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

干预措施: BMS-986259 (Drug)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

干预措施: Placebo (Other)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

干预措施: Iohexol (Diagnostic Test)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

干预措施: BMS-986259 (Drug)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

干预措施: Placebo (Other)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

干预措施: BMS-986259 (Drug)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

干预措施: Placebo (Other)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

干预措施: Iohexol (Diagnostic Test)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

干预措施: BMS-986259 (Drug)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

干预措施: Placebo (Other)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

干预措施: Iohexol (Diagnostic Test)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

干预措施: BMS-986259 (Drug)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

干预措施: Placebo (Other)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

干预措施: Iohexol (Diagnostic Test)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

干预措施: Placebo (Other)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

干预措施: Placebo (Other)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

干预措施: Placebo (Other)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

干预措施: Placebo (Other)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Placebo (Other)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Placebo (Other)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: BMS-986259 (Drug)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Placebo (Other)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

干预措施: Iohexol (Diagnostic Test)

结局指标

主要结局

Incidence of Adverse Events (AEs)

时间窗: Up to 7 weeks

Number of clinically significant changes in vital signs

时间窗: Up to 7 weeks

Number of clinically significant changes in physical examinations

时间窗: Up to 7 weeks

AEs leading to discontinuation

时间窗: Up to 7 weeks

Incidence of Serious Adverse Events (SAEs)

时间窗: up to 7 weeks

Number of clinically significant changes in ECG (electrocardiogram)

时间窗: Up to 7 weeks

Number of clinically significant changes in clinical laboratory tests

时间窗: Up to 7 weeks

次要结局

  • Half life (T-HALF)- Part B and Part C MAD(Up to 7 weeks)
  • Maximum observed concentration(Cmax)-Part B and Part C MAD(Up to 7 years)
  • Half life (T-HALF)- Part A SAD(Up to 7 weeks)
  • Apparent total body clearance(CL/F)-Part A SAD(Up to 7 weeks)
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD(Up to 7 weeks)
  • Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD(Up to 7 weeks)
  • Terminal elimination rate constant (Lz)-Part A SAD(up to 7 weeks)
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD(Up to 7 weeks)
  • Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD(Up to 7 weeks)
  • Terminal elimination rate constant (Lz)-Part B and Part C MAD(up to 7 weeks)
  • Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD(Up to 7 weeks)
  • Maximum observed concentration(Cmax)- Part A SAD(up to 7 weeks)
  • Time of maximum observed concentration(Tmax)- Part A SAD(Up to 7 weeks)
  • Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD(Up to 7 weeks)
  • Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD(Up to 7 weeks)
  • Time of maximum observed concentration(Tmax)-Part B and Part C MAD(Up tp 7 weeks)
  • Apparent total body clearance(CL/F)-Part B and Part C MAD(Up to 7 weeks)
  • Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD(Up to 7 weeks)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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