NCT03445208已完成1 期
An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年2月14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
- 30
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
This is a study of experimental medication BMS-986036 given to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •BMI of 18 to ≤ 40 kg/m2
排除标准
- •Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- •Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- •Known or suspected autoimmune disorder, excluding vitiligo
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any major surgery within 6 weeks of study drug administration
- •History of diabetes mellitus
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Cohort 1
Experimental
BMI 18.0 to ≤ 25.0
干预措施: BMS-986036 (Drug)
Cohort 2
Experimental
BMI >25.0 to ≤ 30.0
干预措施: BMS-986036 (Drug)
Cohort 3
Experimental
BMI >30.0 ≤ 40.0
干预措施: BMS-986036 (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: 29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
时间窗: 29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
时间窗: 29 days
Time of maximum observed serum concentration (Tmax)
时间窗: 29 days
次要结局
- Number of adverse events (AE)(Up to 78 days)
- Serum biomarker antibody concentration(Up to 78 days)
- Number of injection site reactions(Up to 78 days)
- Number of serious adverse events (SAE)(Up to 78 days)
- Number of AEs leading to discontinuation(Up to 78 days)
- Number of deaths(Up to 78 days)
研究者
研究点 (1)
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