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

Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable Nucleos(t)Ide Analogue (NA) Treatment

AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: AHB-137; Drug: AHB-137 and Placebo; Drug: AHB-137 (16weeks)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Chongqing, China
    • The Second Affiliated Hospital of Chongqing Medical University
  • Guangzhou, China
    • Nanfang Hospital, Southern Medical University
  • Jilin, China
    • The First Hospital of Jilin University
  • Fujian
    • Fuzhou, Fujian, China
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • The Third People's Hospital of Zhenjiang

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study and discontinue their NA therapy according to the protocol;
2. At least 18 years old at the time of signing of the informed consent;
3. Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive) ;
4. Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
5. Participants whose serum HBsAg positive for at least 6 months prior to screening;
6. Participants who have stable on NA therapy at least 6 months prior to screening;
7. Participants with HBsAg concentration >100 IU/mL and≤3000 IU/mL, HBV DNA<100 IU/mL;
8. Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
9. For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.

Exclusion Criteria:

1. Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;
2. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
3. Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
4. Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
5. Liver stiffness measurement (LSM) > 9.0 kPa when screening;
6. Diagnosed or suspected hepatocellular carcinoma;
7. The laboratory examination results are obviously abnormal;
8. History of vasculitis or signs and symptoms of potential vasculitis;
9. History of extrahepatic disease that may be related to HBV immune status;
10. 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.
11. Administration of any Interferon within 6 months prior to screening;
12. History of malignant tumor within the past 5 years;
13. 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;
14. Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
15. 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;
16. Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days;
17. Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;
18. 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: AHB-137 and Placebo; AHB-137and placebo will be administered subcutaneously.
Experimental: AHB-137	Drug: AHB-137; AHB-137 injection will be administered subcutaneously.
Experimental: AHB-137 (16 weeks)	Drug: AHB-137 (16weeks); AHB-137 injection will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with different levels of HBsAg reduction compared with baseline		Up to 72 weeks
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137		Up to 24 weeks
Safety: number of participants with adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results, including laboratory examination, electrocardiogram (ECG) examination, physical examination and vital signs		Up to 72 weeks
Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)		Up to 72 weeks
Changes of cytokine levels compared with baseline		Up to 72 weeks
The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma		Up to 72 weeks
The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137		Up to 72 weeks
Plasma concentrations of AHB-137		Up to 72 weeks
Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed		At 8 weeks
Proportion of participants meeting NA treatment discontinuation criteria.		Up to 48 weeks
Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.		Up to 72 weeks
The time from the discontinuation of NA treatment to virological relapse		Up to 72 weeks
The time from the discontinuation of NA treatment to clinical relapse		Up to 72 weeks
Proportion of participants maintaining sustained response.		Up to 72 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 72 weeks

Collaborators and Investigators

• Sponsor: Ausper Biopharma Co., Ltd.
• Investigators: Principal Investigator: Junqi Niu, The First Hospital of Jilin University; Principal Investigator: Jinlin Hou, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): May 26, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• 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
• Other Study ID Numbers: AB-10-8003

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