- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04544826
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
28 de septiembre de 2021 actualizado por: Janssen Research & Development, LLC
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
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
-
-
-
Herston, Australia, 4006
- Nucleus Network, Q-Pharm Pty Ltd
-
-
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 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant must be of first to third generation Japanese descent
- Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Participant must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day-1. If the results of the serum chemistry panel including hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2) and a body weight of between 50 to 90 kg inclusive
- A female participant must have a negative pregnancy test at screening and on Day -1
Exclusion Criteria:
- Coexisting Medical Conditions or Past Medical History: History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Coexisting Medical Conditions or Past Medical History: Has known allergies, hypersensitivity, or intolerance to JNJ-77474462 or its excipients, or any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-77474462 and its excipients used in this study
- Malignancy or Increased Potential for Malignancy: Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk and no evidence of recurrence within 5 years prior to screening
- Concomitant or Previous Medical Therapies Received: Participant is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
- Concomitant or Previous Medical Therapies Received: Has received over the counter medications (including vitamins/multivitamins supplements, corticosteroids, acetaminophen/paracetamol, aspirin, decongestants, antihistamines and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort, and cannabidol) within 2 weeks prior to first study intervention administration unless approved by the investigator and sponsor medical monitor
- Infections or Predisposition to Infections: has an active acute or clinically significant chronic infection
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 Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort 1: JNJ-77474462 (Low Dose) or Placebo
Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
|
JNJ-77474462 will be administered as SC injection.
Otros nombres:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
|
Experimental: Cohort 2: JNJ-77474462 (Medium Dose) or Placebo
Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
|
JNJ-77474462 will be administered as SC injection.
Otros nombres:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
|
Experimental: Cohort 3: JNJ-77474462 (High Dose) or Placebo
Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
|
JNJ-77474462 will be administered as SC injection.
Otros nombres:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
¿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)
Periodo de tiempo: Up to Week 16
|
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
|
Up to Week 16
|
|
Number of Participants with Serious Adverse Events (SAEs)
Periodo de tiempo: Up to Week 16
|
A 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 experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Up to Week 16
|
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
Periodo de tiempo: Up to Week 16
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
|
Up to Week 16
|
|
Number of Participants with Clinically Significant Changes in Vital Signs
Periodo de tiempo: Up to Week 12
|
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
|
Up to Week 12
|
|
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
Periodo de tiempo: Up to Week 12
|
Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.
|
Up to Week 12
|
|
Number of Participants with Clinically Significant Changes in Hematology
Periodo de tiempo: Up to Week 12
|
Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count [RBS], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.
|
Up to Week 12
|
|
Number of Participants with Clinically Significant Changes in Chemistry
Periodo de tiempo: Up to Week 12
|
Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
|
Up to Week 12
|
|
Number of Participants with Clinically Significant Changes in Urinalysis
Periodo de tiempo: Up to Week 12
|
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
|
Up to Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Observed Concentration (Cmax)
Periodo de tiempo: Up to Week 12
|
Cmax is the maximum observed concentration.
|
Up to Week 12
|
|
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
Periodo de tiempo: Up to Week 12
|
AUC(0-infinity) is defined area under the plasma/serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
|
Up to Week 12
|
|
Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
Periodo de tiempo: Up to Week 12
|
AUC(0-last) is defined as area under the plasma/serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
|
Up to Week 12
|
|
Time to Reach Maximum Observed Concentration (Tmax)
Periodo de tiempo: Up to Week 12
|
Tmax is the time to reach maximum observed concentration.
|
Up to Week 12
|
|
Terminal Half-life (T1/2)
Periodo de tiempo: Up to Week 12
|
T1/2 is the terminal half-life.
|
Up to Week 12
|
|
Apparent Total Systemic Clearance (CL/F)
Periodo de tiempo: Up to Week 12
|
CL/F is the apparent total systemic clearance after extravascular administration.
|
Up to Week 12
|
|
Apparent Volume of Distribution (Vz/F)
Periodo de tiempo: Up to Week 12
|
Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.
|
Up to Week 12
|
|
Number of Participants with Antibodies to JNJ-77474462
Periodo de tiempo: Up to Week 12
|
Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported.
|
Up to Week 12
|
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)
16 de octubre de 2020
Finalización primaria (Actual)
5 de agosto de 2021
Finalización del estudio (Actual)
5 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2020
Publicado por primera vez (Actual)
10 de septiembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CR108807
- 77474462ADM1002 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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 JNJ-77474462
-
Janssen Research & Development, LLCRetirado
-
Janssen Research & Development, LLCTerminadoDermatitis AtópicaEstados Unidos, Argentina
-
Janssen Research & Development, LLCTerminadoDermatitis AtópicaEstados Unidos, Alemania, Canadá, Polonia, Japón
-
Janssen Research & Development, LLCTerminado
-
Janssen Research & Development, LLCTerminadoHidradenitis supurativaEstados Unidos, Alemania, Canadá, Japón, Países Bajos, España, Australia, Polonia
-
Janssen Research & Development, LLCActivo, no reclutandoLinfoma No HodgkinDinamarca, España, Israel, Australia
-
Janssen Research & Development, LLCTerminado
-
Janssen Research & Development, LLCTerminado
-
Janssen Research & Development, LLCTerminado
-
Janssen Research & Development, LLCReclutamientoLinfoma No HodgkinAustralia, Bélgica, Turquía (Türkiye)