A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety and tolerability, as measured by clinical adverse events and laboratory assessments
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
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
- Double (Participant, 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
PPI-461 50 mg
or placebo
干预措施: PPI-461 (Drug)
Cohort A
PPI-461 50 mg
or placebo
干预措施: Placebo (Drug)
Cohort B
PPI-461 100 mg
or placebo
干预措施: PPI-461 (Drug)
Cohort B
PPI-461 100 mg
or placebo
干预措施: Placebo (Drug)
Cohort C
PPI-461 200 mg
or placebo
干预措施: PPI-461 (Drug)
Cohort C
PPI-461 200 mg
or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
时间窗: up to Study Day 16 (14 days after the last PPI-461 dose)
Antiviral effects of PPI-461, as measured by HCV RNA levels
时间窗: Up to Study Day 16 (14 days after the last PPI-461 dose)
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations
时间窗: Up to Study Day 10 (8 days after the last PPI-461 dose)
次要结局
未报告次要终点