Quantitative Prediction of Human Pharmacokinetics for Fc-Engineered Therapeutic Monoclonal Antibodies With Increased FcRn Binding Mutations After Subcutaneous Injection.

ABSTRACT: Fc-engineered antibodies (mAbs) enhancing FcRn binding have rapidly expanded in drug discovery and development. Although an approach exists for predicting the pharmacokinetics of Fc-engineered mAbs after intravenous injections in humans, no methodology has been established for predicting pharmacokinetics after subcutaneous injections. This study aimed to establish a methodology for predicting the pharmacokinetics of Fc-engineered mAbs after subcutaneous injections in humans. First, bioavailability (F) and absorption rate constant (k_a) values following subcutaneous injections in humans were collected and analyzed. Then, AUC after subcutaneous injections in humans was predicted using the geometric mean of reported F and allometrically scaled clearance (CL) from cynomolgus monkeys.

SUBMITTER: Haraya K 

PROVIDER: S-EPMC12824526 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature