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Active, Not Recruiting

NCT Number: NCT06829329

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AHB-137

Drug

AHB-137 will be administered .

NAs

Drug

NAs will be administered.

Placebo

Drug

Placebo will be administered .

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

    Time frame: Up to 48 weeks

    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.

  7. Percentage of participants who reached HBeAg negative

    Time frame: Up to 48 weeks

    Only for participants with HBeAg positive at baseline

  8. Percentage of participants achieving HBeAg seroconversion

    Time frame: Up to 48 weeks

    Only for participants with HBeAg positive at baseline

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

    Time frame: Up to 48 weeks

    Only for participants with abnormal ALT at baseline

  10. Time of ALT normalization in absence of rescue therapy

    Time frame: Up to 48 weeks

    Only for participants with abnormal ALT at baseline

  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

    Time frame: Up to 48 weeks

    Examination including laboratory examination, electrocardiogram (ECG) examination

  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

Sponsors and collaborators

Lead sponsor

Ausper Biopharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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