The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
62
Comparison of different dosages of PF-06823859 to placebo
Comparison of Placebo to different doses of PF-06823859
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
Safety
Time frame: Dosing through approximately Day 189
Apparent Clearance (CL) of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859
Immunogenicity
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Plasma Decay Half-Life (t1/2)
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Volume of Distribution at Steady State (Vss) of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
AUCtau (dose normalized)
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
C av of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Mean residence of time for PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189
bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859
Pharmacokinetics
Time frame: Pre dose to approximately Day 189