NCT05256732已完成1 期
Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult 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
- 136
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of AT-527
研究概览
简要总结
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult 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 BID
Experimental
干预措施: AT-527 (Drug)
AT-527
Experimental
干预措施: AT-527 fasted (Drug)
AT-527
Experimental
干预措施: AT-527 fed (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Comparator fasted (Other)
Placebo
Placebo Comparator
干预措施: Placebo Comparator fed (Other)
AT-527 single dose fasted/fed
Experimental
干预措施: AT-527 single dose (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of AT-527
时间窗: Day 1
Trough plasma concentration (Ctrough)
Proportions of subjects experiencing treatment-emergent adverse events
时间窗: Day 1-10
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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