NCT01515358已完成1 期
A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 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
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with one or more drug related adverse events (AEs) or any serious AEs
研究概览
简要总结
The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.
干预措施: Placebo (Drug)
LY3000328
Experimental
Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.
干预措施: LY3000328 (Drug)
结局指标
主要结局
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
时间窗: Baseline to study completion (estimate 3 months)
次要结局
- Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328(Pre-dose up to Day 6 post-dose)
- Pharmacokinetics: Maximum concentration (Cmax) of LY3000328(Pre-dose up to Day 6 post-dose)
- Change in Cathepsin S (CatS) activity(Pre-dose, up to 48 hours post-dose)
研究者
研究点 (1)
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