Preclinical safety evaluation of IT anti-PD1
Because no clinical studies had previously evaluated IT administration of anti-PD1, we first tested this approach in immunocompetent female mice to evaluate safety. For a detailed summary of the animal dosing, please refer to the We evaluated an IT dose of 13 μg of murine anti-PD1 antibody, which was equivalent to a dose of 50 mg in patients based on differences in CSF volumes in mice versus humans. The dose was administered in a volume of 6.5 μl via the cisterna magna and was compared with the effects of IT administration of equal volumes of vehicle or rat immunuglobulin-G2a (IgG2a) control antibodies (vehicle, 