The placebo-controlled, randomized study was designed to assess drug’s safety, tolerability along with pharmacokinetic parameters.
In the Phase 1 SAD study, the maximum tolerated single dose was defined per protocol as 55-60 mg.
The trial enrolled healthy male volunteers between the ages of 18 and 55 and who received s SAD’s over the course of the trial.
The results demonstrated that Anavex 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers.
Anavex executive director George Tidmarsh said with the successful completion of this trial, they will immediately begin a multiple ascending dose trial.