Randomised Phase I study (n=16) comparing PK/PD and safety of six varying doses of a fixed-combination of DMT and harmine across six study days in healthy volunteers with continuous psychological support.
Randomised allocation to one of two sequences (Sequence A or B). Each participant undergoes six study days with a minimum of one day between days; sequences differ by dose order and by inclusion of study days containing only one active ingredient to cover combination effects in a factorial manner.
Pharmacokinetic and pharmacodynamic assessments are obtained over 24 hours on each study visit to estimate dose–exposure relationships and drug–drug interaction; safety/tolerability is monitored continuously and participants receive psychological support in a controlled environment.
Six varying doses of a fixed-combination of DMT and harmine administered across six study days (sequence A).
Fixed-combination DMT + harmine (RE01); six varying doses across study days; harmine co-administered; dosing order per Sequence A.
Six varying doses of a fixed-combination of DMT and harmine administered across six study days (sequence B).
Fixed-combination DMT + harmine (RE01); six varying doses across study days; harmine co-administered; dosing order per Sequence B.