ACTRN12620000295943进行中（未招募）1 期
Part 3 of a three part study-- A Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-729 Administered by Subcutaneous Injection to Subjects with Chronic Hepatitis B Infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not 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 3:
- •- 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.
- •- BMI greater than or equal to 18 kg/m2 and lesser than or equal to 38 kg/m2.
- •- Documented chronic HBV infection as defined in the protocol
- •- HBV-DNA at screening: For HBV-DNA+ subjects (Cohorts G) only: HBV-DNA greater than or equal to 1,000 IU/mL at Screening. For HBV-DNA- subjects (Cohorts E, F, I and J) only: HBV-DNA must be lower than the limit of quantitation at Screening.
排除标准
- •Exclusion Criteria for Study Part 3
- •Known co-infection with any of the following:
- •b. acute hepatitis A virus (HAV),
- •d. hepatitis D virus (HDV), OR
- •e. hepatitis E virus (HEV) infection.
- •Any known preexisting 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
- •b. Immunologically mediated disease or significant immunosuppresion
- •d. Current or history of any clinically significant cardiac abnormalities/dysfunction or uncontrolled
- •hypertension.
- •e. Evidence of decompensated liver disease or findings suggestive of HCC at any time.
- •Evidence of active or suspected malignancy, or a history of malignancy
- •Findings/Diagnostic Assessments at Screening, confirmed by repeat testing:
- •- ALT or AST greater than 2 × upper limit of normal (ULN).
- •- Total bilirubin greater than 1.5 × ULN.
- •- Alpha fetoprotein (AFP) greater than 100 ng/mL.
研究者
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