The aim of the study is to investigate the safety of GH001 (containing
5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of
depressive symptoms, and its dose-related psychoactive effects in patients with
Treatment-Resistant Depression (TRD).
The study is comprised of two open-label, single-arm study parts where Part A evaluates
single doses of GH001 at two dose levels and Part B evaluates a specific individualized
dosing regimen of GH001.