IM and IV SPL026 Drug Product in Healthy Participants

This open-label, crossover study (n=14) assesses the effects of SPL026, administered intramuscularly (IM) and intravenously (IV), in healthy participants with varying degrees of psychedelic experience.

Part A involves psychedelic-experienced participants receiving both IM and IV doses, while Part B includes less experienced or psychedelic-naive participants receiving only IM doses. The trial aims to evaluate safety, tolerability, and pharmacokinetic parameters of SPL026.

Primary outcomes include lab biochemistry, incidence of adverse events, vital signs (heart rate, blood pressure, temperature), ECG readings, physical exams, and suicidal ideation. Secondary outcomes involve evaluating plasma levels of DMT and assessing mystical and challenging experiences using questionnaires.

The study, conducted by Small Pharma Ltd., commenced in January 2023 and concluded in April 2023. Recruitment took place at Hammersmith Medicines Research in London, UK.

Topic Healthy Subjects
Compound DMT
Country United Kingdom
Visit trial
Status Completed
Results Published No
Start date 03 January 2023
End date 05 April 2023
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 14
Sex All
Age 25- 65
Therapy No

Trial Details

The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.

NCT Number NCT05644093

Sponsors & Collaborators

Small Pharma
Small Pharma works on the development of two drugs. Together with Imperial College London they are developing intravenous administration DMT. The other project is a variant on ketamine (SPL801B).

Data attribution

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