[HTML][HTML] A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal …

F Vincenti, G Klintmalm, H Yang, VR Peddi… - American Journal of …, 2020 - Elsevier
This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of
various doses of the anti-CD40 monoclonal antibody bleselumab (ASKP1240) in de novo
kidney transplant recipients receiving concomitant standard immunosuppression over 90
days posttransplant. Transplant recipients were randomized (1: 1: 1: 1: 1) to bleselumab 50
mg, 100 mg, 200 mg, or 500 mg, or placebo, in addition to standard maintenance
immunosuppression. The primary pharmacokinetic endpoints were AUC inf, C max, and …