NCT07630727 Study of AHB-171 in Chronic Hepatitis B Participants

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 138 participants in total. It began in 2026-06-24 with a primary completion date of 2029-03-31.

Brief Summary

The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)

Eligibility Criteria

Inclusion Criteria: * Able to fully understand and sign the informed consent form (ICF). * Male or female participants, aged 18-65 years (inclusive). * Body mass index (BMI) meeting the predefined eligibility range. * Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening. * At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements. * Adopt effective contraceptive measures as required Exclusion Criteria: * History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation. * Prior history of solid organ or hematopoietic stem cell transplantation. * History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk. * History or presence of hepatic decompensation at screening. * History of primary liver cancer, or diagnosis/suspected liver cancer at screening. * Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening * History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation. * Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection). * History of drug abuse, or alcoholism. * Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period. * Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening. * Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening. * Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period. * Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions. * Clinically significant abnormal electrocardiogram (ECG) at screening. * Tested positive for HIV，HCV or active syphilis infection. * Uncontrolled hypertension at screening. * Clinically significant abnormal laboratory test as specified in protocol at screening. * Currently participating in another clinical trials, or within the washout period. * Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.

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