A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Enicepatide in Adult Chinese Participants With Body Mass Index ≥23.0 kg/m2
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m^2).
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习地点
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Beijing、中国、100034
- Peking University First Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- No evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests
- BMI ≥23 kg/m^2 at screening
- Agreement to adhere to the contraception requirements
Exclusion Criteria:
- History of acute or chronic pancreatitis
- History of clinically significant gallbladder disease in the opinion of the investigator
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- History or presence of an abnormal ECG that is deemed clinically significant in the opinion of the investigator
- Clinically significant abnormalities (as judged by the investigator) in laboratory test results
- History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:安慰剂
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Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol. |
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实验性的:Enicepatide Dose 1
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
其他名称:
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实验性的:Enicepatide Dose 2
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence and Severity of Adverse Events
大体时间:Baseline to Safety Follow-Up (27 weeks)
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Baseline to Safety Follow-Up (27 weeks)
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Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
大体时间:Baseline to Safety Follow-Up (27 weeks)
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Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Pulse Rate
大体时间:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Respiratory Rate
大体时间:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Systolic Blood Pressure
大体时间:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Diastolic Blood Pressure
大体时间:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Body Temperature
大体时间:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Plasma Concentration of Enicepatide
大体时间:At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Maximum Plasma Concentration Observed (Cmax) of Enicepatide
大体时间:At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Time to Cmax (Tmax) of Enicepatide
大体时间:At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide
大体时间:At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide
大体时间:At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Absolute Change From Baseline in Body Weight
大体时间:Baseline through Week 24
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Baseline through Week 24
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Percent Change From Baseline in Body Weight
大体时间:Baseline through Week 24
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Baseline through Week 24
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合作者和调查者
调查人员
- 研究主任:Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- YP46402
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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