ACTRN12618001438246撤回1 期
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AB-452 Following Oral Administration in Healthy Subjects and Subjects with Chronic Hepatitis B
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 76
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 (SAD and MD- Healthy Subjects)
- •- 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 2 (CHB Subjects)
- •- Adult male or female subjects, 18 to 65 years of age, inclusive.
- •- 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.
- •- Quantitative HBsAg >/=1000 IU/mL at the Screening Visit.
- •- Subjects must be HBeAg-negative or HBeAg-positive at least 3 months prior to the Screening Visit.
- •- Subjects must be either treatment naive or on-treatment
- •- Liver ultrasound with absence of clinically significant abnormalities is required < /=6 months prior to Day 1.
排除标准
- •Exclusion Criteria for Study Part 1 (SAD and MD- Healthy Subjects)
- •Medical Status or History
- •- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease, Gilbert’s Syndrome.
- •- Positive pregnancy test at Screening or Day -1.
- •Findings/Diagnostic Assessments
- •- Clinically significant ECG or vital sign abnormalities at Screening, Day -1, and Day 1 pre-dose.
- •- Clinically significant abnormalities in laboratory test results at Screening or Day -1 that are confirmed by a repeat reading.
- •Exclusion Criteria for Study Part 2 (CHB Subjects)
- •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. Active/acute 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, or hepatic encephalopathy.
- •c. Liver ultrasound or other imaging with findings suggestive of HCC.
- •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 < /=1 week prior to the first dose of study treatment.
- •Findings/Diagnostic Assessments at Screening, Confirmed by Repeat Testing
- •- QTc interval >450 msec for males or >470 msec for females at Screening or baseline (Day 1) visit.
- •- Total bilirubin >1.5 × upper limit of normal.
研究者
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