Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants with CHB with Low Viral Load

Last updated: February 11, 2025
Sponsor: Ausper Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

AHB-137

Placebo

Clinical Study ID

NCT06829329
AB-10-8008
  • Ages 18-65
  • All Genders

Study Summary

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. About 60 participants will be recruited and randomly divided into two arms.The arms will be stratified based on HBsAg level (HBsAg greater than[>] 100 international unit per milliliter [IU/mL] to less than or equal to [≤]3000 IU/mL or greater than [>] 3000 IU/mL to ≤10000 IU/mL) at screening. The total duration of the study, including screening phase (up to 28 days), treatment phase (16 weeks), and follow-up phase (24 weeks), with a total study duration of approximately 44 weeks for each participant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants voluntarily participate in the study, and sign the Informed ConsentForm (ICF) prior to screening, able to complete the study according to the protocol;

  2. Male or female participants aged 18-65 years old (including the boundary value) atthe time of signing the ICF;

  3. Male participants weighed higher than 50kg and female participants weighted higherthan 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);

  4. Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 monthsprior to screening and has not received antiviral treatment with interferon ornucleos(t)ide analogue ;

  5. At screening, 20 IU/mL<HBV DNA≤2000 IU/mL;

  6. At screening, 100 IU/mL<HBsAg≤10000 IU/mL;

  7. At screening, ALT<3×upper limit of normal (ULN);

  8. For women with childbearing potential should be non-pregnant or non-lactating duringscreening, and participants are willing to take effective contraceptive measuresfrom the screening until the last visit or at least 6 months after the last dosing.

Exclusion

Exclusion Criteria:

  1. Clinically significant abnormalities except chronic HBV infection;

  2. Any clinically significant liver diseases, including but not limited to hepatitiscaused by other pathogenic infections, hemochromatosis, Wilson disease, primarybiliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severenon-alcoholic fatty liver disease, Imaging-diagnosed moderate to severe fatty liver,drug-induced liver injury, history of hereditary liver disease, etc.;

  3. Participants with severe infection requiring systemic anti-infection treatment 1month before randomization;

  4. Co-infection with current or past history of Hepatitis C virus (HCV), Humanimmunodeficiency virus (HIV), Hepatitis D virus (HDV).

  5. Participants who have had or currently have cirrhosis or currently have progressiveliver fibrosis;

  6. Participants who have had or currently have hepatobiliary system tumor; Or bloodalpha-fetoprotein (AFP) ≥ 20 ng/mL during screening, or the liver B-ultrasound, CT,MRI and other imaging examinations suggested the possibility of hepatobiliary systemtumors;

  7. The laboratory examination results are obviously abnormal;

  8. History of vasculitis or signs and symptoms of potential vasculitis;

  9. Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.

  10. History of extrahepatic disease that may be related to HBV immune status;

  11. Administration of immunosuppressants within 3 months prior to screening, except forshort-term use (≤2 weeks) or topical/inhaled steroids. Administration ofimmunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the firststudy intervention or have a history of vaccination within 1 month prior toscreening or planned administration during the study;

  12. History of malignancy within the past 5 years or the discovery of suspected tumorsduring the screening period;

  13. Any suspicion of drug component allergy, or allergic constitution (various drug andfood allergy, and judged by the investigator to be clinically significant) inparticipants;

  14. Participants who have significant trauma or major surgery within 3 months beforescreening, 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 monthbefore screening;

  16. Concurrently participating in another clinical study, or received an investigationalproduct within the following time period prior to the first dosing day in thecurrent study: 5 half-lives or twice the duration of the biological effect of thestudy treatment or 90 days, whichever is longer;

  17. Participants who have received any oligonucleotide or small molecule interferingribonucleic acid (siRNA) drugs;

  18. Any other circumstances or conditions for which the investigator considers that theparticipants are inappropriate to participate in the study.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: AHB-137
Phase: 2
Study Start date:
December 05, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 401336
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310052
    China

    Active - Recruiting

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