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 randomised, double-blind, placebo-controlled trial (n=40) will study the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects of intravenous (IV) and intramuscular (IM) dosing of SPL028 (deuterated DMT fumarate) in healthy volunteers and participants with major depressive disorder (MDD).

The study, conducted by MAC Clinical Research Unit in Manchester, UK, aims to investigate a modified version of N,N-dimethyltryptamine (DMT) called SPL028, which is predicted to have a longer duration of effect compared to standard DMT. The trial is divided into multiple cohorts, with Cohorts 1 and 2 involving experienced psychedelic users (healthy volunteers), and Cohorts 3-5 involving participants with limited psychedelic experience, including those with MDD.

Participants in Cohorts 1 and 2 will receive two doses of the study medication over approximately 15 weeks, while those in Cohorts 3-5 will receive one dose over about 8 weeks. The study involves inpatient stays, follow-up video calls, and various assessments including questionnaires on attitudes, moods, and relationships. The primary objectives are to assess the safety and tolerability of SPL028 administered via IV and IM routes, evaluate its pharmacokinetics and pharmacodynamics, and assess its effects on mood, feelings, thoughts, and beliefs.

Topic Healthy Subjects Depression
Compound DMT
Country United Kingdom
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Trial Details



Trial Number

Sponsors & Collaborators

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.

Data attribution

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