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NCT Number: NCT07630727

Study of AHB-171 in Chronic Hepatitis B Participants

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)

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AHB-171 Injection

Drug

Subcutaneous injection

Primary outcomes

  1. Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)

    Time frame: Up to 90 days

Secondary outcomes

  1. Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)

    Time frame: Up to 90 days

  2. Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit

    Time frame: Up to 90 days

  3. 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

  4. Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit

    Time frame: Up to 90 days

  5. Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit

    Time frame: Up to 90 days

  6. Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit

    Time frame: Up to 90 days

  7. Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit

    Time frame: Up to 90 days

  8. Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit

    Time frame: Up to 90 days

  9. Absolute or log change from baseline for HBsAg at each visit

    Time frame: Up to 90 days

  10. Absolute or log change from baseline for HBV RNA at each visit

    Time frame: Up to 90 days

  11. Absolute or log change from baseline for HBcrAg at each visit

    Time frame: Up to 90 days

  12. Absolute or log change from baseline for HBeAg at each visit

    Time frame: Up to 90 days

  13. Absolute or log change from baseline for HBeAb at each visit

    Time frame: Up to 90 days

  14. Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization

    Time frame: Up to 90 days

  15. Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)

    Time frame: Up to 90 days

    CTCAE will be used to describe severity.

  16. Proportion of participants with clinically significant abnormalities in laboratory tests

    Time frame: Up to 90 days

  17. Proportion of participants with clinically significant abnormalities in ECG

    Time frame: Up to 90 days

  18. Proportion of participants with clinically significant abnormalities in physical examinations and vital signs

    Time frame: Up to 90 days

  19. Changes in ECG from baseline

    Time frame: Up to 90 days

  20. Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL

    Time frame: Up to 90 days

  21. Plasma concentration of AHB-171 at different time points

    Time frame: Up to 90 days

  22. Proportion of participants with detectable anti-drug antibody (ADA)

    Time frame: Up to 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ausper Biopharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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