NCT07626515招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
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
Experimental
干预措施: Enicepatide (Combination Product)
Enicepatide Dose 2
Experimental
干预措施: Enicepatide (Combination Product)
Placebo
Placebo Comparator
干预措施: Placebo (Combination Product)
研究者
研究点 (1)
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