A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211(Efocipegtrutide) in Healthy Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Single ascending dose of HM15211 in healthy obese subjects.
详细描述
A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Female subjects must be non-pregnant and non-lactating
排除标准
- •Participation in an investigational study within 30 days prior to dosing
研究组 & 干预措施
Cohort 2
HM15211 or Placebo (single dose, subcutaneous injection)
干预措施: HM15211 or Placebo (Biological)
Cohort 1
HM15211 or Placebo (single dose, subcutaneous injection)
干预措施: HM15211 or Placebo (Biological)
Cohort 3
HM15211 or Placebo (single dose, subcutaneous injection)
干预措施: HM15211 or Placebo (Biological)
Cohort 4
HM15211 or Placebo (single dose, subcutaneous injection)
干预措施: HM15211 or Placebo (Biological)
Cohort 5
HM15211 or Placebo (single dose, subcutaneous injection)
干预措施: HM15211 or Placebo (Biological)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 1 month
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products
次要结局
未报告次要终点