ACTRN12618000987268终止1 期
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-506, an HBV Capsid Inhibitor, in Healthy Subjects and HBV-DNA Positive Subjects with Chronic HBV Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria for Study Part 1 (Healthy Subjects - SAD) and Part 2 (Healthy Subjects - MD)
- •- Healthy males or females not of childbearing potential aged 18–45, inclusive.
- •- Male subjects must agree to use contraception as detailed in the protocol.
- •- Body mass index (BMI) >/= 18 kg/m2 and < /= 32 kg/m2.
- •Inclusion Criteria for Study Part 3 (CHB MAD)
- •- Adult male or female subjects, 18 to 65 years of age,
- •- Male subjects must agree to use contraception as detailed in the protocol.
- •- Female subjects must not be pregnant and must agree to use contraception as detailed in the protocol.
- •- Body mass index (BMI) >/= 18 kg/m2 and < /= 38 kg/m2.
- •- Documented chronic HBV infection
- •- HBV genotype A, B, C, or D at screening.
- •- Subjects must be either treatment-naïve or treatment-experienced (off-treatment)
- •- HBV-DNA >/= 2,000 IU/mL at screening for HBeAg-negative subjects and HBV-DNA >/= 20,000 IU/mL at screening for HBeAg-positive subjects.
- •- HBsAg >/= 250 IU/mL at screening.
排除标准
- •Exclusion Criteria for Study Part 1 (Healthy Subjects - SAD) and Part 2 (Healthy Subjects - MD)
- •Medical Status or History:
- •- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular disease, or evidence of active or suspected malignancy, or a history of malignancy.
- •Findings/Diagnostic Assessments:
- •- Clinically significant ECG or vital sign abnormalities at Screening, Day -1, or Day 1 pre-dose.
- •- Clinically significant abnormalities in laboratory test results at Screening or Day -1 that are confirmed by a repeat reading.
- •- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •Exclusion Criteria for Study Part 3 (CHB MAD)
- •Medical Status or History:
- •- Known co-infection with any of the following:
- •a. Human immunodeficiency virus (HIV),
- •b. Hepatitis C virus (HCV),
- •c. Hepatitis D virus (HDV), OR
- •d. Hepatitis E virus (HEV).
- •- Any known pre-existing medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to:
- •a. History of any clinically significant medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, a-1-antitrypsin deficiency, alcoholic liver disease, non-alcoholic steatohepatitis, or toxin exposures) that may affect the ability to respond to HBV therapy
- •b. Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, and/or hepatic encephalopathy.
- •c. Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
- •d. Current or history of any clinically significant cardiac abnormalities/dysfunction
- •e. Immune-mediated disease or immunosuppression
- •f. Psychiatric disease
- •g. Malignancy
- •h. Clinically unstable medical condition within 2 weeks prior to the first dose of study treatment.
- •Findings/Diagnostic Assessments at Screening, confirmed by repeat testing:
- •- ALT or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN).
- •- Total bilirubin >1.5 × ULN.
- •- Alpha fetoprotein (AFP) >100 ng/mL. For subjects with AFP results of 50 to 100 ng/mL, historical documentation of a liver ultrasound, computed tomography scan, or magnetic resonance imaging scan performed within 3 months prior to the first dose of study treatment to rule out HCC or other malignancy or liver abnormality must be provided.
研究者
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