NCT04711187已完成1 期
A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects
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
- 81
- 试验地点
- 1
- 主要终点
- Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
研究概览
简要总结
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- •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 18-32 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 28 days of dosing
- •Other clinically significant medical conditions or laboratory abnormalities
研究组 & 干预措施
AT-527 Formulation 2 Dose 3
Experimental
干预措施: Placebo Comparator (Other)
AT-527 Formulation 1 Dose 1
Experimental
干预措施: AT-527 Formulation 1 (Drug)
AT-527 Formulation 1 Dose 1
Experimental
干预措施: Placebo Comparator (Other)
AT-527 Formulation 2 Dose 1
Experimental
干预措施: AT-527 Formulation 2 (Drug)
AT-527 Formulation 2 Dose 2
Experimental
干预措施: Placebo Comparator (Other)
AT-527 Formulation 2 Dose 2
Experimental
干预措施: AT-527 Formulation 2 (Drug)
AT-527 Formulation 1 Dose 3
Experimental
干预措施: AT-527 Formulation 1 (Drug)
AT-527 Formulation 1 Dose 3
Experimental
干预措施: Placebo Comparator (Other)
AT-527 Formulation 2 Dose 3
Experimental
干预措施: AT-527 Formulation 2 (Drug)
AT-527 Formulation 2 Dose 1 Fast/Fed
Experimental
干预措施: AT-527 Formulation 2 (Drug)
AT-527 Formulation 2 Dose 3 Fast/Fed
Experimental
干预措施: AT-527 Formulation 2 (Drug)
结局指标
主要结局
Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
时间窗: Day 10
次要结局
- Pharmacokinetics (PK) of AT-527(Days 1 and 5)
研究者
研究点 (1)
Loading locations...
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