NCT01756482已完成2 期
Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in viral load measurements.
研究概览
简要总结
This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.
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
- Triple (Participant, Care Provider, 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
- •Healthy male or female
- •Between 18 to 45 years old
- •Body Mass Index of 18 to 33 kg/m2
排除标准
- •Acute or chronic medical illness
- •Positive for Human Immunodeficiency Virus, Hepatitis B or C
- •Nose or nasopharynx abnormalities
- •Abnormal lung function
研究组 & 干预措施
GS-5806
Experimental
GS-5806, powder for oral solution
干预措施: GS-5806 (Drug)
Sugar powder for oral solution in juice
Placebo Comparator
Sugar powder for oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Change in viral load measurements.
时间窗: Post initial dose of GS-5806/placebo to Day 12
Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.
次要结局
- Change of baseline symptoms(Innoculation through Day 12)
研究者
研究点 (1)
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