A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
研究概览
简要总结
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, 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
- •Body mass index (BMI) ≥ 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg
- •Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
- •Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
- •Lack of bridging fibrosis or cirrhosis
排除标准
- •Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
- •History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
- •Clinically significant diseases or conditions
- •History of hepatocellular carcinoma
研究组 & 干预措施
ABI-4334
干预措施: ABI-4334 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
时间窗: Through end of study, up to 56 days
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
次要结局
- To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV(Through treatment period, up to 28 days)
- Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334(Through treatment period, up to 28 days)
- Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV(Through treatment period, up to 28 days)
- Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV(Through treatment period, up to 28 days)