Quantitative Approach to Predicting Human Pharmacokinetics of Monoclonal Antibody (DSP-mAbX) from Preclinical Data
DSP-mAbX is a full human monoclonal antibody targeted to a cell surface antigen. The cross-reactivity of DSP-mAbX to the target antigen in human and monkey has already been confirmed. Here, a quantitative translation of DSP-mAbX in vitro and in vivo pharmacology from cynomolgus monkeys to humans is presented. This approach is useful to guide the selection of a safe starting dose for Phase 1 clinical trials based on levels of target occupancy.
American Conference on Pharmacometrics (ACoP) Annual Meeting: October 4-7, 2015, Crystal City, VA
By Kenta Kadotsuji, Susan Willavize, Thaddeus H. Grasela, Yuta Shibue, Jin Shimakura, Yoshiko Tomita, Takao Watanabe, Masashi Yabuki