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Human Mass Balance Study of [¹⁴C]HRS-1893

15 de junio de 2026 actualizado por: Shandong Suncadia Medicine Co., Ltd.
HRS-1893-107 is a Phase 1, single-center, non-randomized, open-label, single-dose study designed to investigate the mass balance, metabolism, and pharmacokinetics of [14C]HRS-1893. The study aims to quantify the radioactive recovery rate, determine the primary excretion pathways, evaluate the whole blood-to-plasma radioactivity ratio, identify major metabolites, and characterize the pharmacokinetic (PK) profile of HRS-1893 and its metabolites. Safety and tolerability will be monitored throughout the trial.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

6

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

Copia de seguridad de contactos de estudio

  • Nombre: Jing He
  • Número de teléfono: +86-0518-82342973
  • Correo electrónico: jing.he@hengrui.com

Ubicaciones de estudio

    • Jiangsu
      • Wuxi, Jiangsu, Porcelana, 214100
        • Jiangnan University Affiliated Hospital
        • Contacto:
        • Investigador principal:
          • Yiqing Zhao

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

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  1. Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
  2. Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
  3. After comprehensive physical examinations (including vital signs, physical examinations, etc.) and laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, fecal routine + occult blood, thyroid function), as well as abdominal B-ultrasound and chest anteroposterior X-ray films, no clinically significant abnormalities were found (ALT, AST, total bilirubin, direct bilirubin, creatine kinase must be < 1.5 times the upper limit of the normal reference value, glomerular filtration rate (eGFR) > 90 mL/(min·1.73 m2)), or the researchers judged that there were minor abnormalities that did not affect the participants' enrollment (such as hemangioma, cyst, calcification focus, nodules, etc.). Among them, abdominal B-ultrasound and chest anteroposterior X-ray films can accept the abdominal B-ultrasound or abdominal CT that can be traced within 6 months before administration, and the results of chest anteroposterior X-ray films or chest CT.
  4. The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be < 450 ms).
  5. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.

Exclusion Criteria:

  1. Systolic blood pressure (SBP) during the screening period or baseline period: SBP ≥ 140 mmHg or < 90 mmHg; Diastolic blood pressure (DBP): DBP ≥ 90 mmHg or < 60 mmHg, and the clinical doctor determines that it has clinical significance.
  2. During the screening period, any one of the following infectious disease screenings - hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody - showing any abnormal result and judged by the researcher to have clinical significance will be included.
  3. There is a history of syncope in the past.
  4. Those who have a history of allergies to drugs, foods, or the environment, or who are allergic to the test drug or any of its components.
  5. Within one month prior to taking the research drug, any prescription drugs, over-the-counter drugs, or herbal medicines were taken; those whose drug half-life was within five half-lives at the time of screening; and those who plan to take non-research trial drugs during the trial period.
  6. Select those who smoked an average of more than 5 cigarettes per day over the past 4 weeks; those who consumed an average of more than 15 grams of alcohol per day in a week (15 grams of alcohol is equivalent to 450 mL of beer or 150 mL of wine or 50 mL of low-alcohol liquor); or those whose alcohol breath test result was greater than 0 mg/100 mL during the screening period; or those who refrained from smoking, drinking alcohol and consuming caffeinated foods or beverages during the screening period and the test period, and had special dietary requirements that they could not comply with the unified diet.
  7. Habitual constipation or diarrhea.
  8. Those with a history of drug use or substance abuse; or those who tested positive for drug abuse in the screening urine test during the selection process.
  9. Those who habitually consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages, or those who are unable to quit during the trial period.
  10. Those who have a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
  11. Screen those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the participants receiving treatment with the trial drugs or medical devices).
  12. Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration.
  13. Those who had experienced blood loss or blood donation of 400 mL within the past 3 months, or those who received blood transfusion within the past 1 month will be selected.
  14. Staff members of the research center or other individuals directly involved in the implementation of the plan.
  15. The researchers believe that there are other circumstances that make the participants unsuitable for this trial, such as those that might increase the risk of the trial, affect the participants' compliance with the protocol, or cause physical or psychological conditions that prevent them from completing the trial.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: [14C]HRS-1893 Group
[14C]HRS-1893.
[14C]HRS-1893 suspension.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Total radioactivity ratio of whole blood/plasma
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Time to reach maximum concentration (Tmax)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Maximum concentration (Cmax)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Half-life (t1/2)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Apparent clearance (CL/F)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Apparent volume of distribution (V/F)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Periodo de tiempo: 0 to anticipated 11 days.
0 to anticipated 11 days.

Colaboradores e Investigadores

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

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)

1 de junio de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

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

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HRS-1893-107

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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. .

Ensayos clínicos sobre [14C]HRS-1893

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