NCT01597947已完成1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) ACHN-975 in Normal Healthy Volunteers
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
- 50
- 试验地点
- 1
- 主要终点
- Frequency of AEs
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 40 and 100 kilograms (between ~88 pounds and ~220 pounds)
- •Use of contraception
- •Stable health
- •Negative tests for alcohol, tobacco, and drugs of abuse
排除标准
- •History of clinically significant disease
- •Pregnancy
研究组 & 干预措施
Arm A
Experimental
干预措施: ACHN-975 (Drug)
Arm B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Frequency of AEs
时间窗: 7 days
Severity of AEs
时间窗: 7 days
次要结局
- Plasma concentrations of ACHN-975(2 days)
- Urine concentrations of ACHN-975(2 days)
研究者
研究点 (1)
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