Prediction of human pharmacokinetics of Fc-engineered therapeutic monoclonal antibodies using human FcRn transgenic mice.

ABSTRACT: Human FcRn transgenic mice (Tg32) have been widely used to evaluate the pharmacokinetics of mAbs and predict human pharmacokinetics. This study aims to establish an approach for predicting the human pharmacokinetics of Fc-engineered mAbs with enhanced FcRn binding mutations using Tg32 mice. MAbs were intravenously administered at 10 mg/kg in the absence or presence of IVIG (1000 mg/kg) in Tg32 mice. Pharmacokinetic parameters (CL, Q, V_c, and V_p) estimated in Tg32 mice were compared with clinical data. Optimal allometric scaling exponents were determined to improve the accuracy of human pharmacokinetic predictions for Fc-engineered mAbs. Moreover, we predicted the plasma concentration-time profile after IV injection in humans using parameters estimated based on an opti

SUBMITTER: Haraya K 

PROVIDER: S-EPMC11938312 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature