Target-Mediated Drug Disposition (TMDD) Modeling of an Anti-TFPI Antibody (MG1113) in Cynomolgus Monkeys to Predict Human Pharmacokinetics and Pharmacodynamics.
CONCLUSIONS: MG1113 showed nonlinear PK after both IV and SC administrations at the dosing range from 2.5~10 mg/kg. The concentrations of MG1113 vs. TFPI could be characterized a dose-response relationship using a TMDD model. The TMDD modeling and simulation built in this study were used to simulate various dosage regimens of MG1113 to apply to the first-in-human study design, and moreover expected to be referred to establish the dose for further clinical trials.
PMID: 33448093 [PubMed - as supplied by publisher]
Source: Thrombosis and Haemostasis - Category: Hematology Authors: Kwak EY, Kim MJ, Park JH, Jung HW, Jung ME Tags: J Thromb Haemost Source Type: research