Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old, diagnosed with persistent or chronic ITP
排除标准
- •Secondary immune thrombocytopenia
- •Drug induced thrombocytopenia
研究组 & 干预措施
Arm A: BMS-986004
BMS-986004 solution intravenously (IV) as specified
干预措施: BMS-986004 75 mg IV (Drug)
Arm B: BMS-986004
BMS-986004 solution intravenously as specified
干预措施: BMS-986004 225 mg IV (Drug)
Arm C: BMS-986004
BMS-986004 solution intravenously as specified
干预措施: BMS-986004 675 mg IV (Drug)
Arm D: BMS-986004
BMS-986004 solution intravenously as specified
干预措施: BMS-986004 1500 mg IV (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
时间窗: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
Number of ECG Abnormalities
时间窗: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
时间窗: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units \[mcg/ml FEU\]). TAT reference range 0-4.1 ng/ml.
次要结局
- Response Rate (RR) of BMS-986004: Short Term and Long Term(Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term))
- Maximum Observed Serum Concentration (Cmax) of BMS-986004(Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h))
- Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004(Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h))
- Trough Observed Serum Concentration (Ctrough) of BMS-986004(Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h))
- Total Body Clearance (CLT) of BMS-986004(Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h))
- AUC Accumulation Index (AI_AUC) of BMS-986004(Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h))