Safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of intravenous dosing of SPL026 drug product (N, N-dimethyltryptamine fumarate; DMT Fumarate [A Serotonergic Psychedelic]) alone or in combination with selective serotonin reuptake inhibitors in patients with major depressive disorder
Open-label Phase I study (n=24 planned; 18 enrolled) single 27.5 mg IV SPL026 (DMT fumarate) 10-minute infusion in adults with major depressive disorder, comparing patients on stable SSRI versus those not on pharmacotherapy; primary outcomes: safety, PK/PD and exploratory efficacy.
Details
Phase Ib open-label study of a single 27.5 mg IV SPL026 (DMT fumarate) infusion administered as a 10-minute continuous infusion in adults with major depressive disorder; two cohorts enrolled: patients on a stable SSRI and patients not receiving pharmacological treatment who receive concurrent therapy.
Primary assessments include adverse events, vital signs, ECG and laboratory safety to Day 29 and C-SSRS for suicidal ideation/behaviour; secondary measures cover PK sampling and multiple PD/psychometric scales (DAS, RRS, SCS-R, WEMWBS, PIS, PTCS, MEQ, EDI, EBI, CEQ, VAS).
Sentinel dosing of two patients in the Test Cohort occurred with a minimum 48-hour safety review before continuation of dosing in the remaining cohort participants.