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

This interventional trial (n=44) studied the safety, tolerability, pharmacokinetics, and QT interval effects of different doses of COMP360 (psilocybin) in healthy volunteers, including an assessment of food effects.

The study consists of two parts:

  1. A single-dose pharmacokinetic (PK) component (n=32): This is a double-blind, placebo-controlled trial testing four doses of COMP360 (1 mg, 10 mg, 25 mg, 50 mg) or placebo in fasting conditions.
  2. A food effect (FE) component (n=12): This is an open-label, randomised crossover trial testing 25 mg of COMP360 in both fasting and fed conditions.

The study aims to investigate the safety and tolerability of COMP360, its pharmacokinetics at different doses and with/without food, and the relationship between drug concentration and QT interval changes.

Participants are healthy volunteers aged 18-55. The study involves dosing sessions with therapist support, overnight stays for monitoring, and various assessments including heart monitoring, blood sampling, and psychological evaluations.

The trial is being conducted at MAC Clinical Research Centre in the UK from November 2020 to October 2022, funded by COMPASS Pathfinder Limited. This Phase I study in healthy volunteers is an important step in developing COMP360 as a potential treatment for depression.

Topic 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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