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A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

28. juli 2026 opdateret af: Ausper Biopharma Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

320

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Yao Xie
        • Kontakt:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina
        • Rekruttering
        • The Second Affiliated Hospital of Chongqing Medical University
        • Ledende efterforsker:
          • Peng Hu
        • Kontakt:
      • Chongqing, Chongqing Municipality, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Kontakt:
        • Ledende efterforsker:
          • Guicheng Wu
    • Fujian
      • Xiamen, Fujian, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Qianguo Mao
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Kontakt:
        • Ledende efterforsker:
          • Xingfei Pan
      • Jiangmen, Guangdong, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Kontakt:
        • Ledende efterforsker:
          • Gang He
      • Meizhou, Guangdong, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Kontakt:
        • Ledende efterforsker:
          • Tianhuang Liu
      • Qingyuan, Guangdong, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Xi He
        • Kontakt:
      • Shenzhen, Guangdong, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Guoxin Hu
        • Kontakt:
    • Guangxi
      • Liuzhou, Guangxi, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Jiaguang Hu
        • Kontakt:
    • Hubei
      • Wuhan, Hubei, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Kai Dai
        • Kontakt:
      • Yichang, Hubei, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Kontakt:
        • Ledende efterforsker:
          • Xiaolin Zhou
    • Hunan
      • Changsha, Hunan, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Jing Ma
        • Kontakt:
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Jie Li
        • Kontakt:
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Xiaoping Wu
        • Kontakt:
    • Jilin
      • Changchun, Jilin, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Yanhang Gao
        • Kontakt:
    • Liaoning
      • Shenyang, Liaoning, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Yang Ding
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Liang Chen
        • Kontakt:
    • Shanxi
      • Xi’an, Shanxi, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Shuangsuo Dang
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Li Zhu
        • Kontakt:
    • Yunan
      • Kunming, Yunan, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Hui Li
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Rekruttering
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Ledende efterforsker:
          • Yunqing Qiu
        • Kontakt:
      • Hangzhou, Zhejiang, Kina
        • Rekruttering
        • AusperBio Investigational Site
        • Ledende efterforsker:
          • Guoping Sheng
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
  • Aged 18-65 years (including boundary values).
  • Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
  • HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
  • HBsAg and HBV DNA values met protocol requirements at screening.
  • ALT < 3xULN at screening.
  • Use highly effective contraception as required.

Exclusion Criteria:

  • Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
  • Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
  • Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
  • Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
  • Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
  • Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
  • Laboratory test results do not meet the criteria.
  • Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
  • Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
  • Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
  • Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
  • Participants are participating in another clinical trial or failing to wash out as required.
  • Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
  • Participants that require regular long-term anticoagulants.
  • Abnormal thyroid function.
  • Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
  • Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AHB-137
AHB-137 will be administered subcutaneously.
Medicin: AHB-137
AHB-137 will be administered subcutaneously.
Placebo komparator: Placebo
Placebo will be administered subcutaneously.
Medicin: Placebo
Placebo vil blive indgivet subkutant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Tidsramme: Up to 48 weeks.
HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
Tidsramme: Up to 48 weeks.

HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.

HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Test Values of Virological Parameters.
Tidsramme: Up to 48 weeks.
HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit.
Up to 48 weeks.
Time to first achievement of HBsAg and first HBeAg seroconversion.
Tidsramme: Up to 48 weeks.

HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.

HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Tidsramme: Up to 48 weeks.
Response options range from 1 to 5 with higher scores indicating more severe impact .
Up to 48 weeks.
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Tidsramme: Up to 48 weeks.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
Up to 48 weeks.
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
AHB-137 resistance analysis.
Tidsramme: Up to 48 weeks.
Method: Sequencing of HBV DNA/RNA.
Up to 48 weeks.
Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
Safety: number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Tidsramme: Up to 48 weeks.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Up to 48 weeks.
Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.
Plasma drug concentration of AHB-137.
Tidsramme: Up to 48 weeks.
Up to 48 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ausper Biopharma Co., Ltd.

Efterforskere

  • Ledende efterforsker: Peng Hu, The Second Affiliated Hospital of Chongqing Medical University
  • Ledende efterforsker: Yunqing Qiu, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2026

Primær færdiggørelse (Anslået)

20. juni 2027

Studieafslutning (Anslået)

20. juni 2028

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AB-10-8016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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