NCT07700329尚未招募1 期
A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Celgene
- 入组人数
- 16
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants
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
- 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
- •Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
- •Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
- •Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.
排除标准
- •Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
- •Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Cohort 2
Experimental
干预措施: BMS-986368-matching Placebo (Other)
Cohort 1
Experimental
干预措施: BMS-986368-matching Placebo (Other)
Cohort 2
Experimental
干预措施: BMS-986368 (Drug)
Cohort 1
Experimental
干预措施: BMS-986368 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to approximately Day 17
Time of maximum observed concentration (Tmax)
时间窗: Up to approximately Day 17
Area under the concentration-time curve (AUC)
时间窗: Up to approximately Day 17
次要结局
- Number of participants with adverse events (AEs)(Up to approximately Day 44)
- Number of participants with serious adverse events (SAEs)(Up to approximately Day 44)
- Number of participants with clinically significant vital sign measurements(Up to approximately Day 17)
- Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations(Up to approximately Day 17)
- Number of participants with clinically significant laboratory assessments(Up to approximately Day 17)
- Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)(Up to approximately Day 17)
- Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)(Up to approximately Day 17)
研究者
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