Ketamine for Major Depressive Disorder

SHX-C301 is a Phase 1, first-in-human, single-blind, multi-centre sequential study to evaluate the pharmacokinetics, safety and antidepressant effects of SHX-001 transdermal patch in subjects with MDD inadequately controlled by standard of care.

Each subject will receive placebo, low dose (20 mg) and high dose (40 mg) patches in the same order across three study periods; primary outcomes include PK measures and safety/tolerability and exploratory antidepressant effects.