The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
11
Guselkumab will be administered subcutaneously.
Risankizumab will be administered subcutaneously.
Medical University Graz
Graz, Austria
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
Skin tissue versus serum concentration ratio will be summarized.
Time frame: Up to Week 12
Part 1: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Time frame: Up to Week 8
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
Colon tissue versus serum concentration ratio will be summarized.
Time frame: Up to Week 4
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
Synovial tissue versus serum concentration ratio will be summarized.
Time frame: Up to Week 12
Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab
Cmax is defined as maximum observed serum concentration.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab
Tmax is defined as time to reach maximum observed serum concentration.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab
AUC(0-last) is defined as area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
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Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity with extrapolation of the terminal phase.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Terminal Half-life (T1/2)
T1/2 is defined as terminal half-life.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab
CL/F is defined as apparent total systemic clearance after extravascular administration.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab
Vz/F is defined as apparent volume of distribution based on terminal phase after extravascular administration.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24
Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab
The detection and characterization of antibodies to guselkumab and risankizumab will be performed using a validated assay method.
Time frame: Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24