- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02290340
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants (MEDI8897 1b)
18 de septiembre de 2018 actualizado por: MedImmune LLC
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children.
The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines.
These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy.
Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.
Tipo de estudio
Intervencionista
Inscripción (Actual)
151
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
-
-
-
Santiago, Chile
- Research Site
-
Valdivia, Chile
- Research Site
-
-
-
-
California
-
Anaheim, California, Estados Unidos
- Research Site
-
Ontario, California, Estados Unidos
- Research Site
-
-
New York
-
Syracuse, New York, Estados Unidos
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos
- Research Site
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos
- Research Site
-
-
Utah
-
Saint George, Utah, Estados Unidos
- Research Site
-
-
Wisconsin
-
Marshfield, Wisconsin, Estados Unidos
- Research Site
-
-
-
-
-
Cape Town, Sudáfrica
- Research Site
-
East London, Sudáfrica
- Research Site
-
Johannesburg, Sudáfrica
- Research Site
-
Pretoria, Sudáfrica
- Research Site
-
-
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
No mayor que 1 año (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Key Inclusion Criteria:
- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
- Infants who are entering their first RSV season at the time of screening
Key Exclusion Criteria:
- Gestational age < 32 weeks 0 days and >34 weeks 6 days
- Meets AAP or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
Participants will receive placebo intramuscularly.
|
Participants will receive placebo intramuscularly.
|
Experimental: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
|
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
|
Experimental: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
|
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
|
Experimental: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
|
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
|
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897.
TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.
|
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Periodo de tiempo: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
|
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor.
The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia.
Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.
|
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Periodo de tiempo: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
|
Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs.
Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.
|
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Maximum Observed Serum Concentration (Cmax) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
The Cmax is the maximum observed serum concentration of MEDI8897.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
|
Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
|
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Terminal Elimination Half Life (t1/2) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Extravascular Clearance (CL/F) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Extravascular Volume of Distribution (Vz/F) of MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Periodo de tiempo: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
|
A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline.
Titers greater than or equal to 50 were considered positive.
|
Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
13 de enero de 2015
Finalización primaria (Actual)
28 de septiembre de 2016
Finalización del estudio (Actual)
28 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
17 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
10 de noviembre de 2014
Publicado por primera vez (Estimar)
14 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D5290C00002
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 Virus sincitial respiratorio
-
The AlfredMerck Sharp & Dohme LLCTerminadoInfección por el virus del papiloma humano | Virus del papiloma humanoAustralia
-
Kanazawa Medical UniversityMerck Sharp & Dohme LLCDesconocidoInfecciones por virus del papiloma | Vacunas contra el virus del papiloma
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention; American Cancer Society, Inc.; New... y otros colaboradoresRetiradoInfección por el virus del papiloma humanoEstados Unidos
-
Merck Sharp & Dohme LLCTerminadoInfección por el virus del papiloma humano
-
Sanford HealthTerminadoInfección por el virus del papiloma humanoEstados Unidos
-
GlaxoSmithKlineTerminadoInfección por el virus del papiloma humanoBaréin
-
Wuhan BravoVax Co., Ltd.Novotech (Australia) Pty Limited; Shanghai BravoBio Co., Ltd.Aún no reclutandoInfección por el virus del papiloma humanoAustralia
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention; New York State Department of Health; Arizona Department of Health Services y otros colaboradoresTerminadoInfección por el virus del papiloma humanoEstados Unidos
-
Merck Sharp & Dohme LLCTerminado
-
Merck Sharp & Dohme LLCKaiser PermanenteTerminadoInfección por el virus del papiloma humano