NCT04649710撤回1 期
A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
Bristol-Myers Squibb3 个研究点 分布在 2 个国家开始时间: 2021年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for > 10 years, and both parents are ethnically Chinese)
- •Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for > 10 years, and both parents are ethnically Korean)
- •Must agree to follow specific methods of contraception, if applicable
排除标准
- •BMI ≥ 40 kg/m^2
- •Women who are pregnant or breastfeeding
- •History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
时间窗: Up to 7 days after first dose and up to 7 days after last dose
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
时间窗: Up to 7 days after first dose and up to 7 days after last dose
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants
时间窗: Up to 7 days after first dose and up to 7 days after last dose
次要结局
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 64 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 64 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS(Up to 64 days)
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests(Up to 64 days)
- Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests(Up to 64 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 64 days)
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests(Up to 64 days)
- Incidence of adverse events (AEs)(Up to 45 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 64 days)
- Incidence of clinically significant changes in physical examination findings(Up to 64 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval(Up to 64 days)
- Incidence of serious adverse events (SAEs)(Up to 70 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Up to 64 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF(Up to 64 days)
研究者
研究点 (3)
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