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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects

6 de abril de 2022 actualizado por: RetroLead (Shanghai) BioPharma Co., Ltd.

A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects

This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

64

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

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

18 años a 45 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the study protocol;
  2. Must be 18 to 45 years of age (inclusive);
  3. Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
  4. Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
  5. Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;

Exclusion Criteria:

  1. History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
  2. Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
  3. Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
  4. Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
  5. Suspected allergy to any ingredient in the study drug;
  6. Use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug;
  7. Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator;
  8. Use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug;
  9. Participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer);
  10. Receiving vaccine(s) within 1 month prior to the first dose of study drug;
  11. Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling;
  12. An average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 3 months before screening;
  13. Subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up;
  14. Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet;
  15. Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
  16. Pregnant or lactating females;
  17. Other conditions judged by the investigator to be not suitable to participate in 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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment group A(Part A)
Drug1: HRS5685, dose 1; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group B(Part A)
Drug1: HRS5685, dose 2; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group C(Part A)
Drug1: HRS5685, dose 3; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group D(Part A)
Drug1: HRS5685, dose 4; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group E(Part A)
Drug1: HRS5685, dose 5; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group F(Part A)
Drug1: HRS5685, dose 6; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group G(Part B)
Drug1: HRS5685, dose 3; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

Experimental: Treatment group H(Part B)
Drug1: HRS5685, dose 4; Drug2: Placebo

Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H

Drug2: Placebo Single dose in group A-F and multiple doses in group G-H

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Safety and tolerability: Incidence and severity of adverse events
Periodo de tiempo: Up to Day 63 after the last dose
Up to Day 63 after the last dose

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Area under the concentration-time curve during a dosing interval (AUCtau),
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Maximum observed concentration (Cmax)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Time to Maximum observed concentration (Tmax)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Half-life (t1/2),
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Apparent clearance (CL/F)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Apparent volume of distribution (Vz/F)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Trough concentration (Ctrough)
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Accumulation ratio (Rac),
Periodo de tiempo: Pre-dose up to Day 63 after the last dose
Pre-dose up to Day 63 after the last dose
Renal clearance (CLr)
Periodo de tiempo: Pre-dose up to 72 hours post-dose
Pre-dose up to 72 hours post-dose
Cumulative amount of drug excreted (Ae)
Periodo de tiempo: Pre-dose up to 72 hours post-dose
Pre-dose up to 72 hours post-dose
Cumulative percentage of dose recovered (fe)
Periodo de tiempo: Pre-dose up to 72 hours post-dose
Pre-dose up to 72 hours post-dose

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 (Anticipado)

15 de abril de 2022

Finalización primaria (Anticipado)

10 de marzo de 2023

Finalización del estudio (Anticipado)

10 de marzo de 2023

Fechas de registro del estudio

Enviado por primera vez

29 de marzo de 2022

Primero enviado que cumplió con los criterios de control de calidad

6 de abril de 2022

Publicado por primera vez (Actual)

14 de abril de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de abril de 2022

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

6 de abril de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

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. .

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