Study of AHB-171 in Chronic Hepatitis B Participants

• AHB-171 Injection (Drug): Subcutaneous injection

Primary outcomes

• Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL) [Up to 90 days]

Secondary outcomes

• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) [Up to 90 days]
• Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit [Up to 90 days]
• Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi [Up to 90 days]
• Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit [Up to 90 days]
• Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit [Up to 90 days]
• Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit [Up to 90 days]
• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit [Up to 90 days]
• Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit [Up to 90 days]
• Absolute or log change from baseline for HBsAg at each visit [Up to 90 days]
• Absolute or log change from baseline for HBV RNA at each visit [Up to 90 days]
• Absolute or log change from baseline for HBcrAg at each visit [Up to 90 days]
• Absolute or log change from baseline for HBeAg at each visit [Up to 90 days]
• Absolute or log change from baseline for HBeAb at each visit [Up to 90 days]
• Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization [Up to 90 days]
• Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) [Up to 90 days]: CTCAE will be used to describe severity.
• Proportion of participants with clinically significant abnormalities in laboratory tests [Up to 90 days]
• Proportion of participants with clinically significant abnormalities in ECG [Up to 90 days]
• Proportion of participants with clinically significant abnormalities in physical examinations and vital signs [Up to 90 days]
• Changes in ECG from baseline [Up to 90 days]
• Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL [Up to 90 days]
• Plasma concentration of AHB-171 at different time points [Up to 90 days]
• Proportion of participants with detectable anti-drug antibody (ADA) [Up to 90 days]

Sex: All, ages: 18 Years to 65 Years

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.