NCT04877769已完成1 期
A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19
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
- 24
- 试验地点
- 1
- 主要终点
- Concentrations of AT-527 in epithelial lining fluid
研究概览
简要总结
This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must agree to use birth control, as required by the protocol.
- •Females must have a negative pregnancy test at Screening and prior to dosing
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 28 days of dosing
- •Concomitant use of prescription medications, or systemic over-the-counter medications
- •Other clinically significant medical conditions or laboratory abnormalities
研究组 & 干预措施
AT-527 Group A
Experimental
n=8
干预措施: AT-527 (Drug)
AT-527 Group B
Experimental
n=8
干预措施: AT-527 (Drug)
AT-527 Group C
Experimental
n=8
干预措施: AT-527 (Drug)
结局指标
主要结局
Concentrations of AT-527 in epithelial lining fluid
时间窗: 4-5 hours after last dose and 11-12 hours after last dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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