The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
48
Participants will receive JNJ-64304500 as SC injection.
Participants will receive matching placebo to JNJ-64304500 as SC injection.
Unnamed facility
Tokyo, Japan
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to End of Study (Day 112)
Maximum Observed Serum Concentration (Cmax)
The Cmax is the maximum observed serum analyte concentration.
Time frame: Up to End of Study (Day 112)
Time to Reach Maximum Observed Serum Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Up to End of Study (Day 112)
Elimination Half-Life (t1/2)
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Time frame: Up to End of Study (Day 112)
Apparent Volume of Distribution (Vd/F)
The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].
Time frame: Up to End of Study (Day 112)
Apparent Total Clearance (CL/F)
The CL/F is defined as Dose/AUC (0-infinity).
Time frame: Up to End of Study (Day 112)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time.
Time frame: Up to End of Study (Day 112)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Up to End of Study (Day 112)
Antibodies to JNJ-64304500
Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported.
Time frame: Up to End of Study (Day 112)
Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500
Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay.
Time frame: Up to End of Study (Day 112)