A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers

Randomised, double-blind, placebo-controlled single-ascending dose study in healthy adults to evaluate safety, tolerability and pharmacokinetics of topically administered NeuroDirect Ketamine and to determine a recommended phase 2 dose.

Three cohorts (25, 50, 100 mg) with 8 participants each (6 active, 2 placebo). PK sampling includes plasma at pre-dose, 0.5,1,2,4,6,8,12 h and 24,48,72,96 h; urine at pre-dose, 1,24,48,72,96 h; one CSF sample at 0.5 h post-dose.