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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04544826
Registration number
NCT04544826
Ethics application status
Date submitted
9/09/2020
Date registered
10/09/2020
Date last updated
29/09/2021
Titles & IDs
Public title
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
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Scientific title
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
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Secondary ID [1]
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77474462ADM1002
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Secondary ID [2]
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CR108807
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77474462
Treatment: Drugs - Placebo
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.
Experimental: Cohort 2: JNJ-77474462 (Medium Dose) or Placebo - Participants will receive single medium dose of JNJ-77474462 or matching placebo 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.
Treatment: Drugs: JNJ-77474462
JNJ-77474462 will be administered as SC injection.
Treatment: Drugs: Placebo
Matching placebo to JNJ-77474462 will be administered as SC injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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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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Timepoint [1]
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Up to Week 16
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Primary outcome [2]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [2]
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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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Timepoint [2]
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Up to Week 16
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Primary outcome [3]
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
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Assessment method [3]
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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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Timepoint [3]
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Up to Week 16
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Primary outcome [4]
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Number of Participants with Clinically Significant Changes in Vital Signs
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Assessment method [4]
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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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Timepoint [4]
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Up to Week 12
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Primary outcome [5]
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Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
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Assessment method [5]
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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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Timepoint [5]
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Up to Week 12
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Primary outcome [6]
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Number of Participants with Clinically Significant Changes in Hematology
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Assessment method [6]
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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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Timepoint [6]
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Up to Week 12
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Primary outcome [7]
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Number of Participants with Clinically Significant Changes in Chemistry
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Assessment method [7]
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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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Timepoint [7]
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Up to Week 12
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Primary outcome [8]
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Number of Participants with Clinically Significant Changes in Urinalysis
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Assessment method [8]
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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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Timepoint [8]
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Up to Week 12
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Secondary outcome [1]
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Maximum Observed Concentration (Cmax)
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Assessment method [1]
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Cmax is the maximum observed concentration.
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Timepoint [1]
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Up to Week 12
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Secondary outcome [2]
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Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
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Assessment method [2]
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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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Timepoint [2]
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Up to Week 12
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Secondary outcome [3]
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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])
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Assessment method [3]
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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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Timepoint [3]
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Up to Week 12
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Secondary outcome [4]
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Time to Reach Maximum Observed Concentration (Tmax)
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Assessment method [4]
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Tmax is the time to reach maximum observed concentration.
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Timepoint [4]
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Up to Week 12
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Secondary outcome [5]
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Terminal Half-life (T1/2)
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Assessment method [5]
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T1/2 is the terminal half-life.
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Timepoint [5]
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Up to Week 12
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Secondary outcome [6]
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Apparent Total Systemic Clearance (CL/F)
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Assessment method [6]
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CL/F is the apparent total systemic clearance after extravascular administration.
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Timepoint [6]
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Up to Week 12
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Secondary outcome [7]
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Apparent Volume of Distribution (Vz/F)
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Assessment method [7]
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Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.
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Timepoint [7]
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Up to Week 12
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Secondary outcome [8]
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Number of Participants with Antibodies to JNJ-77474462
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Assessment method [8]
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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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Timepoint [8]
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Up to Week 12
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/08/2021
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Nucleus Network, Q-Pharm Pty Ltd - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04544826
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04544826
Download to PDF