Study of AHB-171 in Chronic Hepatitis B Participants

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

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.

Conditions2

Interventions1

Related trials

• A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants — Ausper Biopharma Co., Ltd.

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