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A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function

28 de mayo de 2026 actualizado por: Wuhan Createrna Science and Technology Co., Ltd
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):

Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.

During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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.

Ubicaciones de estudio

    • Changchun
      • Jilin City, Changchun, Porcelana, 130000
        • The First Hospital of Jilin University

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:

  • Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
  • Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
  • Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
  • Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
  • Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;

Exclusion Criteria:

  • Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
  • Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
  • Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
  • Active systemic bacterial, viral or fungal infections within 14 days before administration;
  • Fever (≥ 38°C) within 7 days before administration;
  • Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant);
  • Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study;
  • Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;

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: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Experimental: mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Experimental: moderate hepatic impairment (Child-Pugh B) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cmax
Periodo de tiempo: up to 12 weeks
maximum concentration
up to 12 weeks
AUC0-last
Periodo de tiempo: up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
up to 12 weeks
AUC0-inf
Periodo de tiempo: up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
up to 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tmax
Periodo de tiempo: up to 12 weeks
time to reach maximum concentration
up to 12 weeks
CL/F
Periodo de tiempo: up to 12 weeks
apparent clearance
up to 12 weeks
Vz/F
Periodo de tiempo: up to 12 weeks
apparent volume of distribution
up to 12 weeks
t1/2
Periodo de tiempo: up to 12 weeks
terminal half-life
up to 12 weeks
body temperature
Periodo de tiempo: up to 12 weeks
Measure the body temperature of the subjects, using degrees Celsius as the unit.
up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
Periodo de tiempo: up to 12 weeks
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
up to 12 weeks
12-lead ECG
Periodo de tiempo: up to 12 weeks
Evaluate QT interval, PR interval, etc.
up to 12 weeks
adverse events and serious adverse events
Periodo de tiempo: up to 12 weeks
up to 12 weeks
Pulse
Periodo de tiempo: up to 12 weeks
Measure the pulse of the subjects, expressing it in units of beats per minute.
up to 12 weeks
Blood pressure
Periodo de tiempo: up to 12 weeks
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
up to 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: YaNan Wang, PHD, The First Hospital of Jilin University

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 (Actual)

20 de septiembre de 2024

Finalización primaria (Actual)

28 de diciembre de 2024

Finalización del estudio (Actual)

28 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

9 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MY008211-1-09

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

The company's business decision

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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