NCT05366439终止1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])
研究概览
简要总结
This study will assess the safety and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model
详细描述
A Phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of AT-752 in a Dengue Human Challenge Model
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must agree to use protocol-specified methods of contraception
- •Negative pregnancy test
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Abuse of drugs
- •Other clinically significant medical conditions
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo administered orally for 14 days
干预措施: Placebo Comparator (Drug)
AT-752
Experimental
AT-752 administered orally for 14 days
干预措施: AT-752 (Drug)
结局指标
主要结局
Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])
时间窗: Day 2 until 28 days post virus inoculation
次要结局
未报告次要终点
研究者
研究点 (1)
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