Jun 21 2010
Sinapis Pharma, Inc. announces that its first patients were dosed in a Phase I clinical trial study on June 14, 2010. This study, in human volunteers, is designed to evaluate the safety, pharmacokinetics, and absolute bioavailability of an intravenous infusion of methamphetamine. The first cohort, investigating shorter infusion times, went well. Future cohorts will evaluate longer infusion times and higher drug doses.
"We are excited to have launched the clinical development of this drug with the objective of defining the exact dosing schedule to take into a Phase II trial in traumatic brain injury or stroke," said Dr. Donald Picker, company CEO. Sinapis hopes to be able to begin its important proof of principle Phase II trial before year end.