Sinapis Pharma Completes Phase I Trial for Brain Injury Treatment

The trial successfully demonstrated the safety of an IV infusion of Methamphetamine and produced the IV infusion pharmacokinetics needed to initiate Phase IIa clinical studies in stroke patients.

Sinapis Pharma, Inc. announced that it has completed its first clinical trial in the development of its lead drug for the treatment of stroke and traumatic brain injury. 

This was a single-center, open-label, randomized, two-period, two-treatment, two-sequence, single dose, crossover study of the safety and pharmacokinetics of oral and IV administration of methamphetamine HCl in six healthy volunteers.  Subjects were randomized 1:1 to receive a single oral dose of methamphetamine HCl (5 mg Desoxyn? tablet) or a single IV dose of methamphetamine HCl (5 mL of 0.5 mg/mL methamphetamine HCl injection infused over one hour for a total dose of 2.5 mg), and then crossed over to the other treatment (i.e., IV or oral dose, respectively) after a 10 day washout period.  Subjects received a single dose of study drug on Day 1 of each of the two treatment pe