Work

Physiologically-based pharmacokinetic model to predict pharmacokinetics of KY0467 in humans and guide dose selection in infants and children

Year: 2026

Type: article

Abstract: Background: Hand, foot and mouth disease (HFMD) caused by enterovirus 71 (EV71) remains a severe threat to infants and young children, with no specific antiviral therapy currently available. KY0467 is a novel EV71-targeting antiviral drug under clinical development, but clinical data are limited to healthy adults, and appropriate pediatric dosing regimens are urgently needed. Methods: In this study, a physiologically based pharmacokinetic (PBPK) model was developed and validated in rats and beagles, extrapolated to humans, and verified using clinical pharmacokinetic (PK) data from healthy adults. The model was then scaled to infants (28 days-23 months) and children (2-5 years) using age-dependent physiological parameters to predict effective doses matching adult exposure at 30 mg/day. Results: were within 0.5- to 2-fold. Population simulations identified effective doses of 0.5 mg/kg/day for infants and 9 mg/day for children. Conclusions: In conclusion, the adult PBPK model of KY0467 was successfully developed and validated for the first time, and the extrapolated pediatric model could be used to predict pediatric dosing of KY0467, which will provide invaluable references for the design of future clinical trials and its rational use in the pediatric population.

Source: Frontiers in Pharmacology

DOI: 10.3389/fphar.2026.1866331