NCT05414981已完成1 期
A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 9
- 主要终点
- Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
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-H3733 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-H3733 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)
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
- •Current or prior treatment for cHBV
研究组 & 干预措施
ABI-H3733
Active Comparator
干预措施: ABI-H3733 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
时间窗: Through end of study, up to 56 days
次要结局
- Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV(Through treatment period, up to 28 days)
- To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results(Through treatment period, up to 28 days)
- To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR(Through treatment period, up to 28 days)
研究者
研究点 (9)
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