This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
41
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Placebo for PF-06741086, single dose
Pfizer Clinical Research Unit
Brussels, Belgium
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Time frame: Day 1 up to Day 84
Percentage of subjects with laboratory abnormalities
Time frame: Day 1 up to Day 84
Number of subjects with change from baseline in vital signs
blood pressure, pulse rate, temperature, respiration rate
Time frame: Day 1 up to Day 84
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Time frame: Day 1 to Day 84
Percentage of subjects with changes from baseline in physical examination
Time frame: Day 1 to Day 84
Percentage of subjects with infusion site reactions
Time frame: Day 1 up to Day 7
Percentage of subjects with injection site reactions
Time frame: Day 1 to Day 7
Plasma PF-06741086 concentrations
Time frame: Day 1 up to Day 84
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 up to Day 84
Time for Cmax (Tmax)
Time frame: Day 1 up to Day 84
Area under the curve from time zero to last quantifiable concentration (AUClast)
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Time frame: Day 1 up to Day 84
Terminal half-life (t 1/2)
Time frame: Day 1 up to Day 84
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: Day 1 up to Day 84
Volume of distribution at steady state (Vss)
Intravenous administration only
Time frame: Day 1 up to Day 84
Apparent volume of distribution (Vz/F)
Subcutaneous administration only
Time frame: Day 1 up to Day 84
Clearance (CL)
Intravenous administration only
Time frame: Day 1 up to Day 84
Apparent clearance (CL/F)
Subcutaneous administration only
Time frame: Day 1 up to Day 84
Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)]
Time frame: Day 1 up to Day 84
Mean residence time (MRT)
Time frame: Day 1 up to Day 84
Total tissue factor pathway inhibitor concentrations over time
Time frame: Day 1 up to Day 84
Thrombin generation
may include lag time, peak thrombin generation, and endogenous thrombin generation potential
Time frame: Day 1 up to Day 84
Prothrombin fragment 1+2 (PF1+2) concentrations over time
Time frame: Day 1 up to Day 84
D-dimer concentrations over time
Time frame: Day 1 up to Day 84
Dilute prothrombin time (dPT)
Time frame: Day 1 up to Day 84
Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production
Immunogenicity
Time frame: Day 1 up to Day 84