Pharmacokinetics
BLOOD
Blood samples were collected at selected time points during Cycle 1 (predose, end of infusion [EOI], EOI+4h, start of infusion [SOI]+72h, SOI+144h) to perform Isa pharmacokinetics by non‐compartmental analysis using Phoenix WinNonlin® version 8.2 (Pharsight). Gyrolab Platform, a quantitative Sandwich immunoassay using biotinylated anti‐Isa antibodies bound by streptavidin beads within the Gyrolab Bioaffy CD microstructure for capture and Alexa Fluor® 647‐conjugated CD38 antibody for detection, was used to measure functional Isa (Isa with ≥1 site available to bind target) plasma levels, with a lower limit of quantitation of 5.0 μg/ml and an upper limit of quantitation of 500 μg/ml.