A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Antiviral Activity of AT-777 and AT-527
研究概览
简要总结
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.
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)
盲法说明
Part A is randomized, double-blind. Part B is open label.
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
- •Body mass index (BMI) of 18-35 kg/m2
- •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
- •Additional for Part A:
- •18-55 years of age
- •Additional for Part B:
- •18-65 years of age
- •HCV genotype 1, 2 or 3
- •Documented history compatible with chronic hepatitis C
- •HCV RNA ≥ 10,000 IU/mL at Screening
排除标准
- •Pregnant or breastfeeding
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 30 days of dosing
- •Other clinically significant medical conditions
- •Additional for Part B:
- •Prior exposure to any HCV NS5A inhibitor
- •Cirrhosis
- •Co-infection with hepatitis B virus or HIV
研究组 & 干预措施
Part A - 60 mg AT-777 single dose
干预措施: AT-777 (Drug)
Part A - 120 mg AT-777 single dose
干预措施: AT-777 (Drug)
Part A - Placebo single dose
干预措施: Placebo (Drug)
Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks
干预措施: AT-777 (Drug)
Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks
干预措施: AT-527 (Drug)
结局指标
主要结局
Antiviral Activity of AT-777 and AT-527
时间窗: Through 2 weeks of treatment for subjects in Part B
Number of subjects who achieve plasma HCV RNA \< lower limit of quantitation (LLOQ) and target not detected (TND)
Incidence of Treatment-Emergent Adverse Events
时间窗: Through 4 weeks after end of treatment for subjects in Part B
Number of subjects experiencing treatment-emergent adverse events
次要结局
- AT-777 area under the concentration-time curve (AUC)(Day 1 for subjects in Part A)
- AT-777 maximum plasma concentration (Cmax)(Day 1 for subjects in Part A)
- Proportion of subjects achieving sustained virologic response (SVR)(12 weeks after end of treatment for subjects in Part B)