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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
24
JNJ-77474462 will be administered as SC injection.
Matching placebo to JNJ-77474462 will be administered as SC injection.
Nucleus Network, Q-Pharm Pty Ltd
Herston, Australia
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Up to Week 16
Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: Up to Week 16
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
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.
Time frame: Up to Week 16
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
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.
Time frame: Up to Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Participants with Clinically Significant Changes in Hematology
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.
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Chemistry
Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Urinalysis
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
Time frame: Up to Week 12
Maximum Observed Concentration (Cmax)
Cmax is the maximum observed concentration.
Time frame: Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
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.
Time frame: 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])
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.
Time frame: Up to Week 12
Time to Reach Maximum Observed Concentration (Tmax)
Tmax is the time to reach maximum observed concentration.
Time frame: Up to Week 12
Terminal Half-life (T1/2)
T1/2 is the terminal half-life.
Time frame: Up to Week 12
Apparent Total Systemic Clearance (CL/F)
CL/F is the apparent total systemic clearance after extravascular administration.
Time frame: Up to Week 12
Apparent Volume of Distribution (Vz/F)
Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.
Time frame: Up to Week 12
Number of Participants with Antibodies to JNJ-77474462
Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported.
Time frame: Up to Week 12