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

28 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

320

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: AHB-137
AHB-137 will be administered subcutaneously.
Medicamento: AHB-137
AHB-137 will be administered subcutaneously.
Comparador de Placebo: Placebo
Placebo will be administered subcutaneously.
Medicamento: Placebo
O placebo será administrado por via subcutânea.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: 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.
Prazo: Up to 48 weeks.
Up to 48 weeks.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Prazo: Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Prazo: 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.
Prazo: Up to 48 weeks.
Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: Up to 48 weeks.
Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: Up to 48 weeks.
Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Prazo: Up to 48 weeks.
Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Prazo: Up to 48 weeks.
Up to 48 weeks.
AHB-137 resistance analysis.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: Up to 48 weeks.
Up to 48 weeks.
Plasma drug concentration of AHB-137.
Prazo: Up to 48 weeks.
Up to 48 weeks.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ausper Biopharma Co., Ltd.

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de junho de 2026

Conclusão Primária (Estimado)

20 de junho de 2027

Conclusão do estudo (Estimado)

20 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AB-10-8016

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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