NCT03219957已完成1 期
A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected 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
- 88
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •All subjects (healthy and HCV-infected subjects):
- •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- •Must have a negative pregnancy test at Screening and prior to dosing
- •Minimum body weight of 50 kg
- •Willing to comply with the study requirements and to provide written informed consent
- •Additional inclusion criteria for HCV-infected subjects:
- •Must have not received prior treatment for HCV infection
- •Documented clinical history compatible with chronic HCV infection
- •Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.
排除标准
- •All subjects (healthy and HCV-infected subjects):
- •Pregnant or breastfeeding
- •Infected with hepatitis B virus or HIV
- •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
Experimental
干预措施: AT-527 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Comparator (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Through Day 35 for subjects receiving multiple doses.
Number of subjects experiencing treatment-emergent adverse events
次要结局
- Antiviral Activity of AT-527(Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.)
- Pharmacokinetics (PK) of AT-527(Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses)
研究者
研究点 (1)
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