A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
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
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Herston, Austrálie, 4006
- Nucleus Network, Q-Pharm Pty Ltd
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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.
Ostatní jména:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Experimentální: 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.
Ostatní jména:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Experimentální: 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.
Ostatní jména:
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Maximum Observed Concentration (Cmax)
Časové okno: 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])
Časové okno: 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])
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
Další identifikační čísla studie
- CR108807
- 77474462ADM1002 (Jiný identifikátor: Janssen Research & Development, LLC)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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