AHB-171 in Chronic Hepatitis B patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 2 interventional trial evaluating multiple doses of AHB-171 Injection in adults with chronic hepatitis B. Participants include treatment-naïve individuals (both HBeAg-positive and -negative) and those with prior nucleos(t)ide analogue therapy who are HBeAg-negative. The study will monitor safety and efficacy over multiple dosing periods. Inclusion requires documented chronic HBV infection and specific prior treatment histories; key exclusions include major systemic diseases or other liver conditions. The trial is conducted at three AusperBio sites in Beijing, Chongqing, and Xiamen, led by Ausper Biopharma Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• AusperBio Investigational Site
  Beijing, Beijing Municipality, China Recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Recruiting
• AusperBio Investigational Site
  Xiamen, Fujian, China Recruiting
• AusperBio Investigational Site
  Guangzhou, Guangdong, China Recruiting
• AusperBio Investigational Site
  Nanning, Guangxi, China Recruiting
• AusperBio Investigational Site
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Bella Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AHB-137 injection in people with chronic hepatitis B

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• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

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  Recruiting Phase 1 Ausper Biopharma Co., Ltd. · Chongqing, Chongqing Municipality and 4 other locations · NCT07600788

• AHB-171 injectable therapy in healthy adults and chronic hepatitis B patients

  This early test will see if AHB-171 is safe and tolerable in healthy adults and people with chronic hepatitis B, and whether the immune system responds to it.

  Recruiting at 2 sites Phase 1 Ausper Biopharma Co., Ltd. · Ch’ang-ch’un, Jilin and 1 other locations · NCT07511218

• Long-term follow-up of people with chronic hepatitis B after AHB-137 injection

  This follow-up will see how long viral control lasts in people with chronic hepatitis B who had a complete or partial response to AHB-137 injection.

  Recruiting at 8 sites Ausper Biopharma Co., Ltd. · Hefei, Anhui and 36 other locations · NCT07146100

• AHB-137 injection for adults with chronic hepatitis B previously treated with nucleos(t)ide analogue antivirals

  This will test whether AHB-137 injection improves viral control and liver function in adults with chronic hepatitis B who were previously treated with nucleos(t)ide analogue antivirals.

  Recruiting at 4 sites Phase 2 Ausper Biopharma Co., Ltd. · Beijing, Beijing Municipality and 11 other locations · NCT07137910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.