Study of AHB-171 in Chronic Hepatitis B Participants

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B, Chronic (CHB)
• Intervention / Treatment: Drug: AHB-171 Injection

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bella Lu; Phone Number: 0571-86959519; Email: clinicaltrial@ausperbio.com

Study Locations

• China
  • Jilin
    • Jilin City, Jilin, China
      • AusperBio Investigational Site
      • Contact: Bella Lu; Phone Number: 0571-86959519; Email: clinicaltrial@ausperbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHB-171 in Treatment CHB	Drug: AHB-171 Injection; Subcutaneous injection
Experimental: AHB-171 in Naïve CHB	Drug: AHB-171 Injection; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)		Up to 90 days
Reduction 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)	CTCAE will be used to describe severity.	Up to 90 days
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

Collaborators and Investigators

• Sponsor: Ausper Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Organizing Pneumonia; Immune System Diseases; Infections; Virus Diseases; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Hepatitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Hepatitis B
• Other Study ID Numbers: AB-17-8003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No