- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04544826
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
28. september 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Herston, Australien, 4006
- Nucleus Network, Q-Pharm Pty Ltd
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
Andre navne:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
Eksperimentel: 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.
Andre navne:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
Eksperimentel: 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.
Andre navne:
Matching placebo to JNJ-77474462 will be administered as SC injection.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maximum Observed Concentration (Cmax)
Tidsramme: 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])
Tidsramme: 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])
Tidsramme: 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)
Tidsramme: Up to Week 12
|
Tmax is the time to reach maximum observed concentration.
|
Up to Week 12
|
Terminal Half-life (T1/2)
Tidsramme: Up to Week 12
|
T1/2 is the terminal half-life.
|
Up to Week 12
|
Apparent Total Systemic Clearance (CL/F)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. oktober 2020
Primær færdiggørelse (Faktiske)
5. august 2021
Studieafslutning (Faktiske)
5. august 2021
Datoer for studieregistrering
Først indsendt
9. september 2020
Først indsendt, der opfyldte QC-kriterier
9. september 2020
Først opslået (Faktiske)
10. september 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CR108807
- 77474462ADM1002 (Anden identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med JNJ-77474462
-
Janssen Research & Development, LLCTrukket tilbage
-
Janssen Research & Development, LLCAfsluttetDermatitis, atopiskForenede Stater, Argentina
-
Janssen Research & Development, LLCAfsluttetDermatitis, atopiskForenede Stater, Tyskland, Canada, Polen, Japan
-
Janssen Research & Development, LLCAfsluttet
-
Janssen Research & Development, LLCAfsluttetHidradenitis SuppurativaForenede Stater, Tyskland, Canada, Japan, Holland, Spanien, Australien, Polen
-
Janssen Research & Development, LLCRekrutteringLymfom, Non-HodgkinDanmark, Israel, Spanien, Australien
-
Janssen Research & Development, LLCAfsluttet
-
Janssen Research & Development, LLCAfsluttet
-
Janssen Research & Development, LLCAfsluttet
-
Janssen-Cilag International NVAfsluttet