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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from Baseline in Respiratory Rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •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
排除标准
- •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
研究组 & 干预措施
Enicepatide Dose 1
干预措施: Enicepatide (Combination Product)
Enicepatide Dose 2
干预措施: Enicepatide (Combination Product)
Placebo
干预措施: Placebo (Combination Product)
结局指标
主要结局
Change from Baseline in Respiratory Rate
时间窗: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Diastolic Blood Pressure
时间窗: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Body Temperature
时间窗: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Systolic Blood Pressure
时间窗: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Incidence and Severity of Adverse Events
时间窗: Baseline to Safety Follow-Up (27 weeks)
Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
时间窗: Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Pulse Rate
时间窗: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
次要结局
- Plasma Concentration of Enicepatide(At prespecified time points from Day 1 to Day 190)
- Maximum Plasma Concentration Observed (Cmax) of Enicepatide(At prespecified time points from Day 1 to Day 190)
- Time to Cmax (Tmax) of Enicepatide(At prespecified time points from Day 1 to Day 190)
- Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide(At prespecified time points from Day 1 to Day 190)
- Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide(At prespecified time points from Day 1 to Day 190)
- Absolute Change From Baseline in Body Weight(Baseline through Week 24)
- Percent Change From Baseline in Body Weight(Baseline through Week 24)