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SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

RecruitingRegisteredCTG

Randomised, double‑blind, placebo‑controlled Phase I/II two‑part study (n=66 actual) of IV SPL026 (DMT fumarate): single‑dose, dose‑escalation in healthy volunteers; patients with MDD receive dose 1 randomised vs placebo and an open‑label second dose 2 weeks later.

Details

Two‑part study: Part A tests single IV SPL026 in psychedelic‑naïve healthy volunteers in a parallel dose‑escalation design; Part B treats patients with moderate‑severe MDD with up to two single IV doses (dose 1 randomised double‑blind vs placebo; dose 2 open‑label active 2 weeks later).

Outcomes include safety and tolerability, pharmacokinetics and pharmacodynamics, and clinical efficacy measures (eg HAM‑D) with acute and follow‑up assessments.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT04673383