Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection

Laborértékek

• Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
  • Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
  • Co-infection with HCV virus, HIV, or HDV.
  • Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage).
  • Abnormal hematological and biochemical parameters, including:
  • Hemoglobin < 10 g/dl
  • Absolute neutrophil count < 0.75 × 109/L
  • Platelets ≤ 50 × 109/L
  • AST or ALT > 10 × ULN
  • Total Bilirubin > 2.5 × ULN
  • Albumin < 3.0 g/dL
  • INR > 1.5 × ULN (unless stable on anticoagulant regimen)
  • Received solid organ or bone marrow transplant.
  • Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.
  • Significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.
  • Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc).
  • Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
  • Known hypersensitivity to study drugs, metabolites, or formulation excipients.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
  • Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 30 days.

• Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
  • Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
  • Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
  • HBeAg-positive or HBeAg-negative chronic hepatitis B with all of the following: HBV DNA ≥ 2 x 104 IU/mL; Screening serum 1 ULN < ALT level ≤ 10 ULN.
  • Treatment-naive subjects (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue) will be eligible for enrollment. Treatment-experienced subjects receiving oral antiviral treatment at Screening must continue their treatment regimen until the time of randomization, when it will be discontinued.
  • Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit.
  • Estimated creatinine clearance (CLcr) ≥ 50 mL/min（using the Cockcroft-Gault method）based on serum creatinine and actual body weight as measured at the screening evaluation, as follows:
  • （140-age in years）(body weight [kg]) (72)(serum creatinine [mg/dL]） 8) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant).
  • Must be willing and able to comply with all study requirements.