NCT01695876已完成1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
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
- 58
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult subjects between 25 and 55 years old
- •Body mass index (BMI) between 18 and 32 kg/m2
- •Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
- •Additional inclusion criteria apply
排除标准
- •Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.
- •Additional exclusion criteria apply
研究组 & 干预措施
AMG 357
Experimental
AMG 357 is a small molecule for treatment of inflammatory disease
干预措施: AMG 357 (Drug)
Placebo
Placebo Comparator
Matching placebo to AMG 357 containing no active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: up to 35 days
Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.
次要结局
- Effect of Food on AMG 357(up to 11 days)
- Pharmacodynamics(up to 35 days)
研究者
研究点 (1)
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