A Phase 1, Randomized, Double-blind, Multiple-dose Study to Evaluate the Pharmacokinetics of AMG 133 Administered Subcutaneously in Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Maximum Concentration (Cmax) of AMG 133
研究概览
简要总结
The primary objective of this study is to assess the pharmacokinetics (PK) of AMG 133 after multiple subcutaneous (SC) administrations in participants with overweight or obesity using various dose regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AMG 133 Dose A
Participants will receive AMG 133 Dose A SC, followed by subsequent doses of Dose C and Dose D.
干预措施: AMG 133 (Drug)
AMG 133 Dose B
Participants will receive AMG 133 Dose B SC, followed by subsequent doses of Dose C and Dose D.
干预措施: AMG 133 (Drug)
AMG 133 Dose C
Participants will receive AMG 133 Dose C SC, followed by subsequent doses of Dose C and Dose D.
干预措施: AMG 133 (Drug)
结局指标
主要结局
Maximum Concentration (Cmax) of AMG 133
时间窗: Up to Day 99
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133
时间窗: Day 29
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of AMG 133
时间窗: Day 1 and Day 15
次要结局
- Number of Participants Who Develop Anti-AMG 133 Antibodies(Up to Day 99)
- Number of Participants Who Experience Treatment-emergent Adverse Events(Up to Day 99)
- Number of Participants Who Experience Serious Adverse Events(Up to Day 99)