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Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers

25 de enero de 2016 actualizado por: Enzychem Lifesciences Corporation

A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of action of improving neutropenia by promoting neutrophil production from hematopoietic stem cells and at the same time, efficiently controlling STAT6/Complement 3(C3), suggesting its potential to be developed as an orally administered new drug for treatment of neutropenia resulting from decreased neutrophils caused by administration of an anticancer agent.

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

Tipo de estudio

Intervencionista

Inscripción (Actual)

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.

Ubicaciones de estudio

      • Seoul, Corea, república de
        • Yonsei University Health system, Severance Hospital

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

19 años a 45 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  • Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
  • Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI < 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/[height (m)]2
  • No inherited or chronic disease and pathologic symptoms or findings from internal examinations
  • Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug
  • Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial
  • Consent to practice medically acceptable contraception during the trial

Exclusion Criteria:

  • Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity
  • Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records
  • Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records
  • Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history
  • (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON® -TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis
  • Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Single dose group-Group 1-Experimental
Single dose, 500mg of Study drug(EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Single dose group-Group 1-Placebo
Single dose, 500mg of Placebo
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Single dose group-Group 2-Experimental
Single dose, 1000mg of Study drug(EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Single dose group-Group 2-Placebo
Single dose, 1000mg of Placebo
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Single dose group-Group 3-Experimental
Single dose, 2000mg of Study drug (EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Single dose group-Group 3-Placebo
Single dose, 2000mg of Placebo
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Single dose group-Group 4-Experimental
Single dose, 4000mg of Study drug (EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Single dose group-Group 4-Placebo
Single dose, 4000mg of Placebo
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Multiple dose group-Group 1-Experimental
Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Multiple dose group-Group 1-Placebo
Multiple dose, Placebo 500mg, Once daily, for 14 days
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Multiple dose group-Group 2-Experimental
Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Multiple dose group-Group 2-Placebo
Multiple dose, Placebo 1000mg, Once daily, for 14 days
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Multiple dose group-Group 3-Experimental
Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Multiple dose group-Group 3-Placebo
Multiple dose, Placebo 2000mg, Once daily, for 14 days
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)
Experimental: Multiple dose group-Group 4-Experimental
Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Otros nombres:
  • Cápsula blanda EC18
Comparador de placebos: Multiple dose group-Group 4-Placebo
Multiple dose, Placebo 4000mg, Once daily, for 14 days
Placebo with same shape and size
Otros nombres:
  • Placebo for EC-18 (Sofe-capsule)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
No. and severity of Adverse event as a Measure of Safety and Tolerability
Periodo de tiempo: From date of D-1 until Follow-up visit: up to 30 days
From date of D-1 until Follow-up visit: up to 30 days
Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
Periodo de tiempo: From date of screening until Follow-up visit: up to 60 days
From date of screening until Follow-up visit: up to 60 days

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax,ss (Maximum (peak) steady-state plasma drug concentration during a dosage interval)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmin,ss (Minimum steady-state plasma drug concentration during a dosage interval)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cavg,ss (Average steady-state plasma drug concentration during multiple-dose administration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Fluctuation
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: t1/2 (half-life)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCτ (Area under the plasma concentration-time curve from time zero to time t)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCinf (Area under the plasma concentration-time curve from time zero to infinity)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax (Maximum (peak) plasma drug concentration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Tmax (Time to reach maximum (peak) plasma concentration following drug
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Accumulation index
Periodo de tiempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 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

1 de marzo de 2015

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

23 de agosto de 2015

Publicado por primera vez (Estimar)

26 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de enero de 2016

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

25 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EC-18-101

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

I will update the status when it is decided.

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 EC-18

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