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

NCT06993480 | Active Not Recruiting Phase 2

• 1 other identifier: AB-10-8005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 CHB treated with nucleos (t) ide analogues.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

• The changes of peripheral blood cytokines compared to baseline;

  Up to 48 weeks

Study Arms (1)

AHB-137

EXPERIMENTAL

AHB-137 will be injected subcutaneously.

Drug: AHB-137

Interventions

AHB-137 DRUG

AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).

AHB-137

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participated in the study and signed an informed consent form;
• Aged between 18 and 55 years at the time of signing the informed consent form;
• Body mass index (BMI) within the range of 18-30 kg/ m2;
• HBeAg negative or positive 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dazhi Zhang

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): February 9, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)