A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Severity of AEs
研究概览
简要总结
The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.
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
- •Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
- •Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
- •Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
排除标准
- •Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •Presence of any factors that would predispose the participant to develop infection
- •A history of bacterial or fungal meningitis within 1 year prior to screening
- •A history of intracranial or intraspinal bleeding
- •Known intracranial space-occupying mass, including meningioma
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: SAD
SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
干预措施: BMS-986196 (Drug)
Part A: SAD
SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
干预措施: Placebo (Other)
Part B: MAD
MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
干预措施: BMS-986196 (Drug)
Part B: MAD
MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
干预措施: Placebo (Other)
Part C: FE/Formul.
FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.
干预措施: BMS-986196 (Drug)
结局指标
主要结局
Severity of AEs
时间窗: Up to 24 days
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Up to 24 days
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval
时间窗: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
时间窗: Up to 24 days
Causality of AEs
时间窗: Up to 24 days
Severity of SAEs
时间窗: Up to 59 days
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 59 days
Incidence of clinically significant changes in vital signs: Blood pressure
时间窗: Up to 24 days
Incidence of clinically significant changes in physical examination
时间窗: Up to 24 days
Incidence of Adverse Events (AEs)
时间窗: Up to 24 days
Causality of SAEs
时间窗: Up to 59 days
Incidence of clinically significant changes in weight
时间窗: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
时间窗: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
时间窗: Up to 24 days
Incidence of clinically significant changes in ECG parameters: HR
时间窗: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
时间窗: Up to 24 days
次要结局
未报告次要终点