Testing AHB-137 for chronic hepatitis b

Exclusion

• −History of hypersensitivity or allergy to any component of the investigational product (IP).
• −Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
• −Any severe infection (other than chronic HBV infection) within 1 month prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
• −History of extrahepatic diseases potentially associated with HBV infection.
• −Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.
• −Participants will be excluded from the study if any of the following criteria apply:
• −Concomitant clinically significant liver disease.
• −History of immune thrombocytopenia.
• −Current suspected liver cirrhosis and/or evidence of cirrhosis by protocolProtocolThe detailed plan a study must follow.Read more →-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screeningScreeningThe checks done before joining, to see whether a study fits.Read more → is acceptable.
• −History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
• −Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
• −Protocol-specified abnormal laboratory values at Screening.
• −History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.
• −History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.
• −Current alcohol or substance abuse judged by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to potentially interfere with participant compliance.
• −Participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → or receipt of any investigational product prior to first dose in this study within:
• −Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or
• −Six months, if neither half-life nor duration of effect is known
• −Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.
• −Any of the following prior or concomitant therapies:
• −Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical/inhaled corticosteroids
• −Interferon therapy within 12 months prior to first dose
• −Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster
• −Current treatment with bulevirtide
• −Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin.
• −Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.
• −Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study.
• −Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → is confirmed by the Medical Monitor.