A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
研究概览
简要总结
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative bioavailability of two formulations of BMS-986195 with or without food.
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
- •Body Mass Index(BMI) of 18 to 32 kilograms/meter^2
- •Healthy male and female, first generation Japanese with confirmed paternal and maternal Japanese ancestry, 18-55 years old, whose residency outside of Japan does not exceed 10 years with a BMI of 18-30 kilograms/meter^2 inclusive.
- •Women must not be pregnant or breastfeeding
- •Women of Childbearing Potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
排除标准
- •Any significant acute or chronic medical illness
- •Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosis, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (example: history of splenectomy)
- •Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. Behcet's Disease, Psoriasis, pustular dermatoses
- •Any history or risk for tuberculosis (TB)
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Single Ascending Dose (SAD)
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
干预措施: BMS-986195 (Drug)
Single Ascending Dose (SAD)
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
干预措施: Placebo (Other)
Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
干预措施: BMS-986195 (Drug)
Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
干预措施: Placebo (Other)
Japanese-Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
干预措施: BMS-986195 (Drug)
Japanese-Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
干预措施: Placebo (Other)
Relative Bioavailability with Food Effects (Open Label)
干预措施: BMS-986195 (Drug)
结局指标
主要结局
Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
时间窗: Up to 8 days during and after last dose
Safety and tolerability of multiple oral doses of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
时间窗: Up to 21 days during and after last dose
次要结局
未报告次要终点