Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)
24 de mayo de 2026 actualizado por: AusperBio Therapeutics Inc.
A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB).
Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
144
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Debbie Liao
- Número de teléfono: (650) 650-2877
- Correo electrónico: ausperbioclinicaltrials@ausperbio.com
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Auckland
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Grafton, Auckland, Nueva Zelanda, 1010
- New Zealand Clinical Research
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Male or female participants, aged 18-65 years old (inclusive)
- Body Mass Index between 19 to 35 kg/m2 (inclusive)
- Body weight > or = 45 kg.
- Documented HBV infection for ≥6 months prior to randomization.
- For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
- For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
- Screening electrocardiogram (ECG) without clinically significant abnormalities
- Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
- Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
- Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.
Exclusion Criteria:
- Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
- Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
- History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
- Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
- HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
- Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
- Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
- Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
- History or signs of vasculitis or related autoimmune diseases.
- Malignancy within 5 years (except non-melanoma skin cancer).
- Allergy to study drug components.
- Recent major surgery/trauma (within 3 months) or planned surgery during study.
- Alcohol or substance abuse affecting compliance.
- Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
- Participation in another clinical trial or recent investigational product use.
- Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
- Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
- Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
- Any other condition making the participant unsuitable (per investigator).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
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Administración oral
Injection
Injection
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Experimental: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
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Administración oral
Injection
Injection
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Experimental: AHB-171 and placebo in CHB (Part C: finite MD)
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Injection
Injection
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Experimental: AHB-171 and placebo in CHB (Part D: finite MD)
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Injection
Injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Adverse Events (AEs) [Safety and Tolerability]
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Periodo de tiempo: Up to 72 weeks
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Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
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Up to 72 weeks
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Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
Periodo de tiempo: Up to 72 weeks
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12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.
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Up to 72 weeks
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Incidence of laboratory abnormalities [Safety and Tolerability]
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
|
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Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Change from baseline in alanine aminotransferase (ALT) levels
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants experiencing virologic relapse.
Periodo de tiempo: Up to 72 weeks
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Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
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Up to 72 weeks
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Time to participants experiencing virologic relapse.
Periodo de tiempo: Up to 72 weeks
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Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
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Up to 72 weeks
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Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Plasma PK parameters AUC of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Plasma PK parameter Cmax of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
|
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Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
|
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Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
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Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
Periodo de tiempo: Time Frame: Up to 72 weeks
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Time Frame: Up to 72 weeks
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Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Periodo de tiempo: Up to 72 weeks
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Up to 72 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
6 de julio de 2026
Finalización primaria (Estimado)
8 de octubre de 2027
Finalización del estudio (Estimado)
14 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Infecciones
- Enfermedades virales
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Hepatitis, Viral, Humana
- Enfermedades contagiosas
- Infecciones por virus de ADN
- Infecciones por Hepadnaviridae
- Hepatitis Crónica
- Hepatitis
- Condiciones Patológicas, Signos y Síntomas
- Hepatitis B
- Hepatitis B Crónica
Otros números de identificación del estudio
- AB-17-8001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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