Pharmacokinetics analysis
Free inclacumab plasma concentrations were measured in samples collected from participants using a Meso Scale Discovery electrochemiluminescence assay. This validated ligand-binding assay captured inclacumab in plasma using a biotin-labeled anti-inclacumab mAb bound to a blocked streptavidin plate (Meso Scale Discovery). Captured inclacumab was then detected with a SULFO-TAG-labeled anti-inclacumab mAb. The method was applicable to the quantitation of inclacumab within a nominal range of 10 to 2560 ng/mL and required a minimum 20.0 μL human plasma aliquot containing sodium citrate. Samples were frozen at approximately − 80 °C before analysis. The analysis was performed at PPD Bioanalytical Laboratory (Richmond, VA, USA).