Application of Dose Modification Strategies in HDP-101-01 FH Trial Guided Through Modelling & Simulation
Time: 9:30 am
day: Conference Day One
Details:
- A two-compartment model with linear clearance was applied to describe the PK of the total antibody
- PKPD modelling and simulation analyses confirmed that dose mitigation strategies reduced the impact of HDP-101 on thrombocytes by dose splitting or administering pre-medication with corticosteroids and antihistamines
- HDP-101 demonstrated an excellent safety profile up to 112.5 ug/kg/cycle dosing where the RP2D is anticipated
