Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and effects of intravenous (IV) and intramuscular (IM) dosing of SPL028 (deuterated DMT fumarate [a serotonergic psychedelic]) in healthy volunteers and participants with major depressive disorder (MDD)
Randomised, double-blind, placebo-controlled Phase I trial (n=38) assessing safety, tolerability, PK and PD of IV and IM SPL028 (deuterated DMT fumarate) in healthy participants; optional Part B (MDD) did not take place.
Details
Phase I, double-blind study in healthy participants testing SPL028 (deuterated DMT fumarate) administered by IV infusion or IM injection across up to five cohorts; randomisation in Part A was 6 active:2 placebo per cohort and cohorts 1–2 included two treatment periods spaced 3–6 weeks apart.
Outcomes included safety/tolerability (AEs, vitals, ECG, labs), suicidal ideation/behaviour (BSS), PK (frequent sampling: IV up to 2 h, IM up to 4 h), PD measures (WEMWBS, STAI-T, MEQ, EDI, EBI, CEQ, PTCS) and blinding integrity; Part B (open-label MDD cohort) did not take place.