A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way

This Phase I trial (n=44) aims to assess the safety, tolerability, and pharmacokinetics (how the drug is absorbed, distributed, and eliminated by the body) of COMP360 (psilocybin) in healthy volunteers. The study also investigates how food intake affects the body’s response to a 25 mg dose and examines the relationship between COMP360 dosage and heart function, specifically the QT interval (a measure of electrical activity in the heart).

The study consists of two parts. The first part is a single-dose, double-blind, placebo-controlled trial involving 32 participants who receive one of four doses of COMP360 (1 mg, 10 mg, 25 mg, or 50 mg) or a placebo under fasting conditions. The second part is an open-label, randomised crossover trial with 12 participants receiving a 25 mg dose of COMP360 twice—once after fasting and once after a high-fat meal—to evaluate the effects of food intake. Participants are closely monitored for 24 hours post-dose, with assessments of heart function, blood pressure, and overall well-being.

The study was conducted at MAC Clinical Research Centre (UK) and funded by Compass.

Topic Safety Healthy Subjects
Compound Psilocybin
Country United Kingdom
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Trial Details



Trial Number

Sponsors & Collaborators

COMPASS Pathways
COMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.

Data attribution

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