The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
109
Parexel
Baltimore, Maryland, United States
Pharmacodynamic variable: Individual subject cell surface antigen (CD40) occupancy levels over time
binding of ASKP1240-biotin to B cells
Time frame: Days 1-3, 5, 8,15, 22, 29, 43, 60, 75, and 90
Pharmacokinetics profile: AUCinf and Cmax
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) and Maximum concentration of study drug (Cmax)
Time frame: Days 1-8,15, 22, 29, 43 and 60
Pharmacokinetics profile: AUClast, tmax, t1/2, Vz, and CLtot
Area under the plasma concentration-time curve from time 0 up to the last quantifiable concentration (AUClast),Time to attain Cmax (tmax), Apparent terminal elimination of half-life (t1/2), Apparent volume of distribution ( Vz), and Total body clearance (CLtot)
Time frame: Days 1-8,15, 22, 29, 43 and 60
Total lymphocyte count
product of the white blood count (WBC) and percent lymphocytes \[from differential\]
Time frame: Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60
Peripheral lymphocyte subset quantification
leukocycte phenotypes: CD3, CD4, CD8,CD16, and CD20
Time frame: Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60
Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs), physical examination, pulse oximetry, and incidence of anti-ASKP1240 antibody formation
Time frame: Up to day 90
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