Study of AHB-171 in Chronic Hepatitis B Participants

Official title

An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B

Overview

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)

Interventions

• Drug AHB-171 Injection
  Subcutaneous injection

Primary outcome measures

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

Secondary outcome measures (12)

• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) [Time frame: Up to 90 days]
• Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit [Time frame: 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 [Time frame: Up to 90 days]
• Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit [Time frame: Up to 90 days]
• Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit [Time frame: Up to 90 days]
• Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit [Time frame: Up to 90 days]
• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit [Time frame: Up to 90 days]
• Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit [Time frame: Up to 90 days]
• Absolute or log change from baseline for HBsAg at each visit [Time frame: Up to 90 days]
• Absolute or log change from baseline for HBV RNA at each visit [Time frame: Up to 90 days]
• Absolute or log change from baseline for HBcrAg at each visit [Time frame: Up to 90 days]
• Absolute or log change from baseline for HBeAg at each visit [Time frame: Up to 90 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 10 centers

• AusperBio Investigational Site — Beijing
• AusperBio Investigational Site — Chongqing
• AusperBio Investigational Site — Xiamen
• AusperBio Investigational Site — Guangzhou
• AusperBio Investigational Site — Nanning
• AusperBio Investigational Site — Zhengzhou
• AusperBio Investigational Site — Changzhou
• AusperBio Investigational Site — Jilin City
• … and 2 more centers

Identifiers

NCT: NCT07630727 · AB-17-8003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗