Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: AHB-137; Drug: Placebo; Drug: NAs

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 401336
      • The Second Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Mengchao Hepatobiliary Hospital OF Fujian Medical University
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • The Third People's Hospital of Zhenjiang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310052
      • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
• Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
• Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
• Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
• At screening, ALT<3×upper limit of normal (ULN);
• Use effective contraception as required;
• HBV DNA within the specified range at screening;
• HBsAg was within the specified range at screening.

Exclusion Criteria:

• Clinically significant abnormalities except chronic HBV infection;
• Any clinically significant liver diseases;
• Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
• Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
• Hepatobiliary neoplasm malignant;
• The laboratory examination results are obviously abnormal;
• History of vasculitis or signs and symptoms of potential vasculitis;
• Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
• History of extrahepatic disease that may be related to HBV immune status;
• Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
• History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
• Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
• Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
• Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHB-137 and placebo	Drug: AHB-137; AHB-137 will be administered .; Drug: Placebo; Placebo will be administered .
Experimental: AHB-137 and Nucleos(t)Ide Analogue (NAs)	Drug: AHB-137; AHB-137 will be administered .; Drug: NAs; NAs will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.		Up to 48 weeks
Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.		Up to 48 weeks
Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.		Up to 48 weeks
Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb		Up to 48 weeks
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb		Up to 48weeks
Percentage of participants who reached HBeAg negative	Only for participants with HBeAg positive at baseline	Up to 48 weeks
Percentage of participants achieving HBeAg seroconversion	Only for participants with HBeAg positive at baseline	Up to 48 weeks
Proportion of participants with ALT normailzation in absence of rescue therapy.	Only for participants with abnormal ALT at baseline	Up to 48 weeks
Time of ALT normalization in absence of rescue therapy	Only for participants with abnormal ALT at baseline	Up to 48 weeks
Safety: number of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events(TRAEs), serious adverse events (SAE) and clinically significant examination results	Examination including laboratory examination, electrocardiogram (ECG) examination	Up to 48 weeks
Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)		Up to 48 weeks
The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma		Up to 48 weeks
The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137		Up to 48 weeks
Plasma concentrations of AHB-137		Up to 48 weeks
Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline	This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Ausper Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hepatitis B, Chronic
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic; Substandard Drugs; Pharmaceutical Preparations; nas
• Other Study ID Numbers: AB-10-8008

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
• product manufactured in and exported from the U.S.: No