- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04544826
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
28 settembre 2021 aggiornato da: 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.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
24
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Herston, Australia, 4006
- Nucleus Network, Q-Pharm Pty Ltd
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Cohort 1: JNJ-77474462 (Low Dose) or Placebo
Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
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JNJ-77474462 will be administered as SC injection.
Altri nomi:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Sperimentale: Cohort 2: JNJ-77474462 (Medium Dose) or Placebo
Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
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JNJ-77474462 will be administered as SC injection.
Altri nomi:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Sperimentale: Cohort 3: JNJ-77474462 (High Dose) or Placebo
Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
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JNJ-77474462 will be administered as SC injection.
Altri nomi:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: Up to Week 16
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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.
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Up to Week 16
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Number of Participants with Serious Adverse Events (SAEs)
Lasso di tempo: Up to Week 16
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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.
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Up to Week 16
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
Lasso di tempo: Up to Week 16
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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.
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Up to Week 16
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Number of Participants with Clinically Significant Changes in Vital Signs
Lasso di tempo: Up to Week 12
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Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
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Up to Week 12
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Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
Lasso di tempo: Up to Week 12
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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.
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Up to Week 12
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Number of Participants with Clinically Significant Changes in Hematology
Lasso di tempo: Up to Week 12
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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.
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Up to Week 12
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Number of Participants with Clinically Significant Changes in Chemistry
Lasso di tempo: Up to Week 12
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Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
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Up to Week 12
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Number of Participants with Clinically Significant Changes in Urinalysis
Lasso di tempo: Up to Week 12
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Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
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Up to Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maximum Observed Concentration (Cmax)
Lasso di tempo: Up to Week 12
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Cmax is the maximum observed concentration.
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Up to Week 12
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Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
Lasso di tempo: Up to Week 12
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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.
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Up to Week 12
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Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
Lasso di tempo: Up to Week 12
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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.
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Up to Week 12
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Time to Reach Maximum Observed Concentration (Tmax)
Lasso di tempo: Up to Week 12
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Tmax is the time to reach maximum observed concentration.
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Up to Week 12
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Terminal Half-life (T1/2)
Lasso di tempo: Up to Week 12
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T1/2 is the terminal half-life.
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Up to Week 12
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Apparent Total Systemic Clearance (CL/F)
Lasso di tempo: Up to Week 12
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CL/F is the apparent total systemic clearance after extravascular administration.
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Up to Week 12
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Apparent Volume of Distribution (Vz/F)
Lasso di tempo: Up to Week 12
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Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.
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Up to Week 12
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Number of Participants with Antibodies to JNJ-77474462
Lasso di tempo: Up to Week 12
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Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported.
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Up to Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 ottobre 2020
Completamento primario (Effettivo)
5 agosto 2021
Completamento dello studio (Effettivo)
5 agosto 2021
Date di iscrizione allo studio
Primo inviato
9 settembre 2020
Primo inviato che soddisfa i criteri di controllo qualità
9 settembre 2020
Primo Inserito (Effettivo)
10 settembre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 settembre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 settembre 2021
Ultimo verificato
1 settembre 2021
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CR108807
- 77474462ADM1002 (Altro identificatore: Janssen Research & Development, LLC)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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