In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
146
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Pfizer Investigational Site
Overland Park, Kansas, United States
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Time frame: Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Time frame: Day 1 - Day 57
Systemic Clearance (CL)
Time frame: Day 1 - Day 57
Terminal Disposition Half-Life (t1/2)
Time frame: Day 1 - Day 57
Volume of Distribution at Steady State (Vss)
Time frame: Day 1 - Day 57
Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)
Time frame: Day 1 - LSLV or Day 85 whichever occurs later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.