ACT201 Injection in Participants With Chronic Hepatitis B (CHB) on Nucleos(t)Ide Analog Therapy - Phase Ib

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

Fase 1

Rango de edad

18 años - 65 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

40 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

This is a multicenter, randomized, open-label, parallel-controlled Phase Ib clinical trial. It aims to evaluate the safety and preliminary efficacy of ACT201 Injection combined with standard therapy (PegIFNα, NA) in participants with chronic hepatitis B who are receiving NA treatment. A total of 40 participants with chronic hepatitis B will be enrolled. Eligible participants should have stable NA treatment, HBV DNA \< 100 IU/mL, negative HBeAg, and HBsAg ≤ 100 IU/mL. They will be randomized into four treatment groups at a 1:1:1:1 ratio.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• Voluntarily participate in this trial and sign the informed consent form;
• Aged 18 to 65 years (inclusive), male or female;
• Body mass index (BMI) ranging from 18 to 32 kg/m² (inclusive);
• HBsAg-positive or HBV DNA-positive for at least 6 months, or with prior liver biopsy results consistent with chronic HBV infection, or HBsAg-positive and anti-HBc IgM-negative at screening;
• Receiving stable nucleos(t)ide analogue (NA) therapy at screening;
• Meeting the specified requirements for HBsAg, HBeAg, HBV DNA and liver function parameters;
• Willing to use effective contraception with no plan to conceive, donate sperm or donate ova.

Exclusion Criteria:

• Subjects who have sustained major trauma or undergone major surgery recently, or have a planned surgery;
• Subjects with uncontrolled, clinically significant abnormalities or other severe illnesses in addition to chronic HBV infection;
• Subjects with a history of other liver diseases;
• Subjects with a history of liver cirrhosis;
• Subjects with imaging findings suggestive of a suspected malignant hepatic lesion;
• Subjects with prior or current manifestations of hepatic decompensation;
• Subjects with a history of extrahepatic diseases potentially associated with HBV immune status;
• Subjects with other diseases associated with vasculitis;
• Subjects with infections (other than HBV) requiring systemic antiviral or antibacterial therapy at screening;
• Subjects with a history of malignancy;
• Subjects with prior solid organ or bone marrow transplantation;
• Subjects with current or past history of severe psychiatric disorders;
• Subjects with severe retinopathy or other severe ophthalmologic diseases;
• Subjects who have received prohibited study drugs previously or currently;
• Subjects with concomitant hematological diseases;
• Subjects with abnormal laboratory findings;
• Subjects with abnormal QTcF interval;
• Subjects with a history of allergy;
• Subjects who are breastfeeding or have a positive serum pregnancy test at screening;
• Subjects participating in another clinical trial, or those who have not completed the washout period specified in the protocol prior to this trial;
• Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this trial.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

Asignación al azar

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (4)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

4 centros

Equipo y fechas

Patrocinador principal

Xiamen Amoytop Biotech Co., Ltd.

Inicio del estudio

20 nov 2026 Estimado

Finalización primaria

2027-02 Estimado

Finalización del estudio

2027-12 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio