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Active, not recruitingNCT06829329Updated Jul 29, 2026

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

A Phase 2 interventional study of AHB-137 and NAs in Chronic Hepatitis B, sponsored by Ausper Biopharma Co., Ltd.. Active, not recruiting at 6 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Ausper Biopharma Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Hepatitis B

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Keywords

  • Hepatitis B, Chronic
03

In context

Hepatitis B, Chronic

942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.

This study's enrollment of 105 is close to the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Ausper Biopharma Co., Ltd. is the lead sponsor of 12 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    AHB-137 and placebo

    Drug: AHB-137 · Drug: Placebo

  • Experimental
    AHB-137 and Nucleos(t)Ide Analogue (NAs)

    Drug: AHB-137 · Drug: NAs

Interventions

  • DrugAHB-137

    AHB-137 will be administered .

  • DrugNAs

    NAs will be administered.

  • DrugPlacebo

    Placebo will be administered .

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.

    Time frame: Up to 48 weeks

  2. Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.

    Time frame: Up to 48 weeks

  3. Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.

    Time frame: Up to 48 weeks

  4. Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb

    Time frame: Up to 48 weeks

  5. Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb

    Time frame: Up to 48weeks

  6. 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.

    Time frame: Up to 48 weeks

  7. Percentage of participants who reached HBeAg negative

    Only for participants with HBeAg positive at baseline

    Time frame: Up to 48 weeks

  8. Percentage of participants achieving HBeAg seroconversion

    Only for participants with HBeAg positive at baseline

    Time frame: Up to 48 weeks

  9. Proportion of participants with ALT normailzation in absence of rescue therapy.

    Only for participants with abnormal ALT at baseline

    Time frame: Up to 48 weeks

  10. Time of ALT normalization in absence of rescue therapy

    Only for participants with abnormal ALT at baseline

    Time frame: Up to 48 weeks

  11. 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

    Time frame: Up to 48 weeks

  12. Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)

    Time frame: Up to 48 weeks

  13. The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma

    Time frame: Up to 48 weeks

  14. The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137

    Time frame: Up to 48 weeks

  15. Plasma concentrations of AHB-137

    Time frame: Up to 48 weeks

07

Study locations

6 sites
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality 401336, China
  • Mengchao Hepatobiliary Hospital of Fujian Medical University
    Fuzhou, Fujian, China
  • AusperBio Investigational Site
    Guangzhou, Guangdong, China
  • AusperBio Investigational Site
    Changzhou, Jiangsu, China
  • The Third People's Hospital of Zhenjiang
    Zhenjiang, Jiangsu, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310052, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06829329
Lead sponsor
Ausper Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Feb 17, 2025
Start date
Dec 13, 2024
Primary completion
Aug 2, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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