A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
详细描述
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or female, ages 18 to 65 years
- •Documented chronic HCV infection, genotype 1a or 1b
- •Treatment-naïve
- •BMI = 18 - 35 kg/m2
排除标准
- •Female patients who are pregnant or breast-feeding
- •Previous treatment for HCV infection
- •HIV or HBV positive
- •Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
- •History of any other known cause of liver disease;
研究组 & 干预措施
Cohort 1
Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid
干预措施: ANA598 200 mg bid or placebo (Drug)
Cohort 2
Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid
干预措施: ANA598 400 mg bid or placebo (Drug)
Cohort 3
Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid
干预措施: ANA598 800 mg bid or placebo (Drug)
结局指标
主要结局
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
时间窗: 10 days
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
时间窗: 10 days
次要结局
未报告次要终点