NCT01797419撤回1 期
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<24 months of age
- •Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening
排除标准
- •Chronic or congenital heart disease
- •Required ventilation or admission to any pediatric Intensive Care Unit
- •Inadequate organ function
研究组 & 干预措施
GS-5806
Experimental
Single dose, oral liquid, .5 mL/kg
干预措施: GS-5806 (Drug)
Placebo
Placebo Comparator
Single dose, oral liquid, .5 mL/kg
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 10 days from subject randomization to study drug
Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.
次要结局
- Pharmacokinetics effects of GS-5806(10 days from subject randomization to study drug)
研究者
研究点 (9)
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