A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study in Healthy Volunteers and Patients With Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANA773 Tosylate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
研究概览
简要总结
The overall study design includes two parts, Part A and Part B.
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
详细描述
Study Design:
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male or female, ages 18 to 65 years
- •Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months
- •Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL
- •Naïve to or have relapsed from prior IFN-alpha based therapy
排除标准
- •Female subjects who are pregnant or breast-feeding
- •Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication
- •Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days
- •History of significant medical condition that could interfere with study medication or associated study assessments
- •History of or current drug or alcohol abuse
研究组 & 干预措施
Part A, Group 1 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part A, Group 1 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part A, Group 2 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part A, Group 2 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part A, Group 3 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part A, Group 3 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part A, Group 4 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part A, Group 4 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part A, Group 5 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part A, Group 5 Healthy Volunteer
a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part B, Group 6 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part B, Group 6 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part B, Group 7 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part B, Group 7 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part B, Group 8 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2)
干预措施: ANA773 (Drug)
Part B, Group 8 HCV Infected Patient
multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2)
干预措施: Placebo (Drug)
Part B, Group 9 HCV Infected Patient
multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2)
干预措施: ANA773 (Drug)
Part B, Group 9 HCV Infected Patient
multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
时间窗: Up to 41 Days
Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
次要结局
- Immunological effects in both Healthy Subjects and Chronic HCV Patients(Up to 41 days)