This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
164
PF-06410293 40 mg administered subcutaneously by Prefilled syringe
PF-06410293 40 mg administered subcutaneously by prefilled pen
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Maximum serum concentration (Cmax)
Time frame: Day 1 - Day 15
Area under the concentration curve (AUC 0-2wk)
Time frame: Day 1-Day 15
Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose
Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device
Time frame: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose
Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device
Time frame: 1, 3, 8, 12 and 24 hours post injection
Time to reach the maximum serum concentration (Tmax)
Time frame: Day 1 - Day 43
AUC from time 0 to the last time point with quantifiable concentration (AUCT)
Time frame: Day 1 - Day 43
AUC extrapolated to infinity (AUC0 inf)
Time frame: Day 1 - Day 43
Volume of distribution (Vz/F),
Time frame: Day 1 - Day 43
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Apparent clearance (CL/F)
Time frame: Day 1 - Day 43
Terminal half life (t1/2)
Time frame: Day 1 - Day 43