A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 14
- 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 three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥ 18 and ≤ 65 years of age.
- •In good general health except for chronic HBV infection, documented by:
- •Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
- •Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
- •Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
排除标准
- •History or evidence of decompensated liver disease at any time prior to Screening
- •History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
- •Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
- •Previous treatment with a commercially approved HBV therapy within the last 6 months
研究组 & 干预措施
ABI-H2158
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
干预措施: ABI-H2158 (Drug)
Matching Placebo for ABI-H2158
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
干预措施: Placebo for ABI-H2158 (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 28 days
次要结局
未报告次要终点