The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
78
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.
Nucleus Network, Q-Pharm Pty Ltd
Herston, Australia
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
Cmax is the maximum observed plasma concentration.
Time frame: Up to Week 12
Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Time frame: Up to Week 12
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
Time frame: Up to Week 12
Terminal Half-Life (T1/2) of JNJ-77474462
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Time frame: Up to Week 12
Absolute Subcutaneous (SC) Bioavailability (F%)
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).
Time frame: Up to Week 12
Percentage of Participants with Treatment-emergent Adverse Events (TEAE)
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 adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.
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Time frame: Up to Week 12
Percentage of Participants with Serious Adverse Events (SAE)
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 12
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (including body temperature, resting \[supine\] pulse/heart rate, respiratory rate and blood pressure) will be reported.
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
Number of participants with clinically significant changes ECG will be reported.
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Laboratory Findings
Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.
Time frame: Up to Week 12
Number of Participants with Anti-JNJ-77474462 Antibodies
Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.
Time frame: Up to Week 12