🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07630727
Recruiting Phase 2

Study of AHB-171 in Chronic Hepatitis B Participants

NCT07630727 · tracked via the Priya Life Science China tracker
Sponsor
Ausper Biopharma Co., Ltd.
Phase
Phase 2
Started
2026-06-24
Last updated
2026-07-21

Condition(s) studied

Hepatitis B, Chronic (CHB)

Investigational drug(s) / intervention(s)

AHB-171 Injection

AHB-171 Injection: Subcutaneous injection

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
AusperBio Investigational Site Beijing Beijing Municipality Recruiting
AusperBio Investigational Site Chongqing Chongqing Municipality Recruiting
AusperBio Investigational Site Xiamen Fujian Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Nanning Guangxi Recruiting
AusperBio Investigational Site Zhengzhou Henan Recruiting
AusperBio Investigational Site Changzhou Jiangsu Recruiting
AusperBio Investigational Site Jilin City Jilin Recruiting
AusperBio Investigational Site Chengdu Sichuang Recruiting
AusperBio Investigational Site Hangzhou Zhejiang Recruiting

More Ausper Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07630727 on ClinicalTrials.gov ↗ ← All trials in China