NCT00822978已完成1 期
A Double-Blind, Randomized, Placebo-controlled, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in 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
- 39
- 试验地点
- 1
- 主要终点
- Incident and severity of adverse events
研究概览
简要总结
This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Within normal weight limits
- •In good health with normal routine laboratory results
- •Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noise
排除标准
- •No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
- •No problems with hearing or balance
- •No previous injury or surgery the the ears
- •No family history of hearing loss before the age of 65
- •Not taking any medication other than birth control medication
- •Smokers or use of tobacco products
- •Recent blood donor
- •Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)
研究组 & 干预措施
ACHN-490 Injection
Active Comparator
ACHN-490 Injection in escalating doses
干预措施: ACHN-490 Injection vs placebo (Drug)
2
Placebo Comparator
Placebo is normal saline
干预措施: ACHN-490 Injection vs placebo (Drug)
结局指标
主要结局
Incident and severity of adverse events
时间窗: 2 weeks after the last dose for each dose group
次要结局
- Changes from baseline in kidney function, laboratory values, abd vital signs(single and multi-dose)
- Pharmacokinetic parameters(After single and multiple-dose administration)
研究者
研究点 (1)
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