A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

Phase 2

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: AHB-137

• Registration Number: NCT06993480
• Lead Sponsor: Ausper Biopharma Co., Ltd.

Brief Summary

AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with HBeAg-negative CHB treated with nucleos (t) ide analogues.

Detailed Description

The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with HBeAg-negative CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an AHB-137 treatment period (24 weeks) and a follow-up period (24 weeks).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-28
• Study Start: 2025-06-18
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Voluntarily participated in the study and signed an informed consent form;
• Aged between 18 and 50 years at the time of signing the informed consent form;
• Body mass index (BMI) within the range of 18-30 kg/ m2;
• HBeAg negative at screening;
• HBsAg or HBV DNA positive for at least 6 months;
• Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
• 100 IU/mL < HBsAg ≤ 3000 IU/mL and HBV DNA < 100 IU/mL at screening;
• Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
• Effective contraception as required.

Exclusion Criteria

• Clinically significant abnormalities other than a history of CHB infection;
• Concomitant clinically significant other liver diseases;
• Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
• Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
• Liver stiffness value (LSM) > 9.0 kPa at screening;
• Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
• Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
• Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
• History of extrahepatic disease possibly related to HBV immune status;
• Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy;
• Receiving or using any interferon-containing therapy within 12 months prior to screening;
• History of malignancy within 5 years prior to screening or being evaluated for possible malignancy;
• Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant);
• Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
• Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening;
• Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
• Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment;
• Obviously abnormal laboratory test results;
• History of vasculitis or signs and symptoms of underlying vasculitis;
• Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AHB-137	AHB-137	AHB-137 will be injected subcutaneously.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
The changes of peripheral blood cytokines compared to baseline;	Up to 48 weeks
The changes of peripheral blood immune cell phenotypes compared to baseline;	Up to 48 weeks
The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline;	Up to 48 weeks
The changes in peripheral blood metabolomics compared to baseline;	Up to 48 weeks
The changes in peripheral blood proteomics compared to baseline;	Up to 48 weeks
The changes in liver metabolomics compared to baseline, if applicable ;	Up to 48 weeks
AHB-137 drug concentrations, and metabolite profiling, if applicable;	Up to 48 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA);	Up to 48 weeks
Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ.	Up to 48 weeks
Proportion of participants maintaining sustained response;	Up to 48 weeks
The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;	Up to 48 weeks
The changes in the phenotype of liver immune cells compared to baseline;	Up to 48 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.	Up to 48 weeks	Examination including laboratory examination, electrocardiogram (ECG) examination.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China