NCT03198182已完成1 期
A Randomized, Parallel, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 in Healthy Japanese and Non-Japanese Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年6月28日最近更新:
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
- 63
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
- •Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese)
- •Exclusion Criteria
- •Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- •Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- •Known or suspected autoimmune disorder, excluding vitiligo
- •Other protocol defined inclusion/exclusion criteria could apply
排除标准
- 未提供
研究组 & 干预措施
Module A
Experimental
BMS-986036 Arm
干预措施: BMS-986036 (Drug)
Module B
Placebo Comparator
Placebo Arm
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 42 days
Safety
Incidence of serious adverse events (SAEs)
时间窗: Up to 42 days
Safety
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's DiseaseAlzheimer Disease, Early OnsetNCT06268886Bristol-Myers Squibb310
已完成
1 期
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy ParticipantsFibrosisNCT03142165Bristol-Myers Squibb33
已完成
2 期
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic DermatitisDermatitis, AtopicNCT05014438Bristol-Myers Squibb17
进行中（未招募）
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT06003426Bristol-Myers Squibb1,255
进行中（未招募）
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisProgressive Pulmonary FibrosisNCT06025578Bristol-Myers Squibb1,057