A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
研究概览
简要总结
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.
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
- Single (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
干预措施: ABI-H0731 (Drug)
ABI-H0731 or Matching Placebo
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
干预措施: ABI-H0731 (Drug)
ABI-H0731 or Matching Placebo
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
干预措施: Placebo for ABI-H0731 (Drug)
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
干预措施: Entecavir (Drug)
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
干预措施: Tenofovir disoproxil fumarate (Drug)
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: ABI-H0731 (Drug)
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: Pegasys (Drug)
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: Nucleos(t)ide (Drug)
结局指标
主要结局
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
时间窗: Up to 57 days
次要结局
未报告次要终点