Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change between pre- and post-intervention safety and tolerability assessments
研究概览
简要总结
First in human study of ALY688-SR administered as a subcutaneous injection
详细描述
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,
排除标准
- •Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia
研究组 & 干预措施
ALY688-SR
single dose subcutaneous injection
干预措施: ALY688-SR (Drug)
Matching placebo for ALY688-SR
single dose subcutaneous injection
干预措施: ALY688-SR (Drug)
结局指标
主要结局
Change between pre- and post-intervention safety and tolerability assessments
时间窗: baseline, pre-intervention through study completion at 16 days
Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations
次要结局
未报告次要终点