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A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC), in Healthy Adult Volunteers

Qué se está evaluando

3K3A-APC, diluted in 0.9% sodium chloride in water

+ 3K3A-APC, diluted in 0.9% sodium chloride in water

BiológicoMedicamento

Quiénes están siendo reclutados

De 18 a 55 años

+25 Criterios de eligibilidad

Ver todos los criterios de elegibilidad

Cómo está diseñado el estudio

Otro tipo de estudio

Controlado con PlaceboFase 1

Intervencional

Inicio del estudio: agosto de 2012

Ver detalles del protocolo

Resumen

Patrocinador PrincipalZZ Biotech, LLC

Última actualización: 5 de febrero de 2018

Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2012

Fecha en la que se inscribió al primer participante.

This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses. Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo (Cohorts 1-6). Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12 hours for 5 doses (Cohorts 7-10). Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for 12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for observation and PK sampling. Subjects will return on Study Day 4 (~72 hours after infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be made to subjects to collect AEs that occur within 28-days of the dose. Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for observation and PK sampling. Subjects will return on Study Day 6 (~72 hours after last infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be made to subjects to collect AEs that occur within 28-days of the last dose.

NCT01660230

Patrocinador PrincipalZZ Biotech, LLC

Última actualización: 5 de febrero de 2018

Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Detalles del Diseño

Se reclutarán 64 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.

Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 55 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

7 criterios de inclusión requeridos para participar

Age 18 to 55 years, inclusive

Agreement to abstain from smoking and drinking alcoholic beverages from 48 hours prior to randomization through last Study Day (15)

Body Mass Index (BMI) of 19 to 30 kg/m2, inclusive (see APPENDIX B)

Both men and women of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age > 40 years without menses for >= 2 years) must agree to use a barrier method of contraception plus a spermicide throughout the study

Mostrar Más Criterios

18 criterios de exclusión impiden participar

Activated partial thromboplastin time (aPTT) greater than upper limit of normal (ULN)

Any medical problem for which the subject is being evaluated and/or treated

Any other clinically significant abnormalities in laboratory values (chemistries, hematology, coagulation studies, and urinalysis - see APPENDIX C)

Any other condition, that in the opinion of the Site Investigator, may adversely affect the safety of the subject, the subject's ability to complete the study, or the outcome of the study

Mostrar Más Criterios

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.

Grupos de Tratamiento

Objetivos del Estudio

11 grupos de intervención están designados en este estudio

9.090909090909092% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo

Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes

Grupo II

Comparador Activo

Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes

Grupo III

Comparador Activo

Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes

Grupo IV

Comparador Activo

Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes

Grupo 5

Comparador Activo

Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes

Grupo 6

Comparador Activo

Cohort 6: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes

Grupo 7

Comparador Activo

Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses

Grupo 8

Comparador Activo

Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses

Grupo 9

Comparador Activo

Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses

Grupo 10

Comparador Activo

Cohort 10: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses

Grupo 11

Placebo

Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Privatklinik Leech

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Completado1 Centros de Estudio