Study Director: Jonathan C. White, M.S.A.
This study was conducted for Cellphire, Inc., to evaluate the safety of the test article, Canine Thrombosomes™, following a single infusion dose of 10x the native platelet protein per animal (10x) or 3 doses of 1x the native platelet protein per animal (3x). Two treatment groups of six male and six female beagle dogs were to be administered the test article at respective doses of 1x or 10x, with half the animals necropsied on each Day 2 and 15. Animals receiving the 1x dose were to receive doses three times on Day 1, approximately 2 hours between doses, followed by one administration of Fresh Canine Platelets (100 mL). Due to a shortage of test article, three animals/sex were administered the 1x or 10x dose then scheduled for necropsy on Day 15 and two animals/sex were dosed for the scheduled Day 2 necropsy. Due to a dosing error, the two animals/sex scheduled for the Day 2 necropsy, were actually administered a single dose of approximately 2.4x followed by the fresh canine platelets. Animals in the 10x dose group received a single administration of the test article followed by a single dose of fresh canine platelets. One additional group of six animals/sex served as the control and received a single dose of the vehicle, Thrombosomes™ Buffer at a fixed volume of 105 mL, the mean dose volume administered to the 10x dose group animals. The test article or vehicle was administered to all groups via intravenous infusion.
Based on the results of this study, canine thrombosomes administered as a single dose of 10x, a single dose of 2.4x (misdosed group) or 3 doses of 1x administered approximately 2 hours apart were considered non-adverse.