Quantitative Approach to Predicting Human Pharmacokinetics of Monoclonal Antibody (DSP-mAbX) from Preclinical Data

Authors: Kadotsuji K, Willavize S, Grasela TH, Shibue Y, Shimakura J, Tomita Y, Watanabe T, Yabuki M
Conference: ACoP
Keywords: antibody, DSP-mAbX, mabx, monoclonal, occupancy, Phase 1, PK, preclinical, target
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

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