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)

This interventional trial (n=38) assessed the safety, tolerability, pharmacokinetics (how the drug is absorbed and processed by the body), and pharmacodynamics (how the drug affects the body) of SPL028 (a modified form of DMT) when given intravenously (IV) or intramuscularly (IM) in healthy volunteers.

SPL028 is a deuterated form of DMT, designed to have a longer-lasting effect compared to standard DMT, which is the main psychedelic compound in ayahuasca. The study aims to evaluate the safety and psychological effects of SPL028, particularly its impact on mood, thoughts, and beliefs. It includes multiple cohorts, with healthy volunteers who have prior psychedelic experience receiving two doses over 15 weeks, while MDD patients with little to no prior psychedelic use receive a single dose over an 8-week period. Participants will stay in a clinic under medical supervision, with follow-up assessments including psychotherapy sessions.

The study was conducted at the MAC Clinical Research Unit in Manchester, UK, and has now been completed. The planned second (B) part with MDD patients didn’t take place.

Topic Healthy Subjects Safety
Compound DMT
Country United Kingdom
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Trial Details



Trial Number

Sponsors & Collaborators

MAC Clinical Research


Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

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