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

28. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

320

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AHB-137
AHB-137 will be administered subcutaneously.
Legemiddel: AHB-137
AHB-137 will be administered subcutaneously.
Placebo komparator: Placebo
Placebo will be administered subcutaneously.
Legemiddel: Placebo
Placebo vil bli administrert subkutant.

Hva måler studien?

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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ausper Biopharma Co., Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2026

Primær fullføring (Antatt)

20. juni 2027

Studiet fullført (Antatt)

20. juni 2028

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AB-10-8016

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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