NCT03392116已完成1 期
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM120 in Healthy Adult Subjects
NGM Biopharmaceuticals, Inc1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年1月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Part A Arm-Single Dose: Treatment Emergent Adverse events
研究概览
简要总结
The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Normal ECG findings
排除标准
- •Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
研究组 & 干预措施
Part A: Placebo
Placebo Comparator
Single Dose
干预措施: Placebo (Other)
Part B: Placebo
Placebo Comparator
Multiple Dose
干预措施: Placebo (Other)
Part A: NGM120
Experimental
Single Dose
干预措施: NGM120 (Biological)
Part B: NGM120
Experimental
Multiple Dose
干预措施: NGM120 (Biological)
结局指标
主要结局
Part A Arm-Single Dose: Treatment Emergent Adverse events
时间窗: 28 days
Percentage of total subjects with Treatment Emergent Adverse event
Part B Arm-Multiple Dose: Treatment Emergent Adverse events
时间窗: 84 days
Percentage of total subjects with Treatment Emergent Adverse event
次要结局
未报告次要终点
研究者
研究点 (1)
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