NCT04857606已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Subject Incidence of Treatment-emergent Adverse Events
研究概览
简要总结
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 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 609
Experimental
Up to 7 cohorts ranging by various dose levels.
干预措施: AMG 609 (Drug)
Placebo
Experimental
Participants will receive the matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Subject Incidence of Treatment-emergent Adverse Events
时间窗: Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
时间窗: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
时间窗: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
时间窗: Baseline to Day 113
次要结局
- Maximum Observed Concentration (Cmax) of AMG 609(Up to Day 150)
- Time to Maximum Observed Concentration (Tmax) of AMG 609(Up to Day 150)
- Area Under the Concentration Time Curve (AUC) of AMG 609(Up to Day 150)
研究者
研究点 (10)
Loading locations...
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