A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 51
- 主要终点
- Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
研究概览
简要总结
This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women of non-child bearing potential,
- •Between the ages of 18 and 55 inclusive,
- •Body mass index from 18 to 33 kg/m2,
- •Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct.
排除标准
- •Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia,
- •Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system,
- •History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.
研究组 & 干预措施
AMG 403
AMG 403 administered as subcutaneous and intravenous doses
干预措施: AMG 403 (Drug)
Placebo
No active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
时间窗: up to 112 days
Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.
Incidence of abnormal clinically significant vital signs
时间窗: up to 112 days
Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.
Incidence of abnormal clinically significant ECG results
时间窗: up to 112 days
ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.
Incidence of treatment emergent adverse events
时间窗: up to 112 days
次要结局
- Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax(up to 112 days)