A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

This Phase I/II randomised, double-blind, placebo-controlled trial (n=57) studied the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of CYB003, a synthetic psilocybin analogue, in healthy participants and those with major depressive disorder (MDD).

The study, conducted by Cybin Inc. at three locations in the United States, aims to assess CYB003 in both healthy volunteers and MDD patients across multiple dosing sessions. Participants with MDD will receive supportive EMBARK psychotherapy throughout the trial, while healthy volunteers will receive psychological support. The study design includes various arms testing different dosing regimens of CYB003 compared to placebo, with dosing sessions spaced approximately 1-3 weeks apart depending on the participant group.

Key objectives include evaluating the safety profile of CYB003, its effects on depressive symptoms in MDD patients, and examining pharmacokinetic parameters. The trial also includes a cohort to assess bioavailability and food effects. Participants aged 21-65 years with specific health criteria are eligible. This phase I/IIa study represents an important step in developing CYB003 as a potential novel treatment for depression.

Original Title: A Study of a Psilocybin Analog (CYB003) in Participants With Major Depressive Disorder

Topic Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Completed
Results Published No
Start date 19 July 2022
End date 18 January 2024
Chance of happening 89%
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation Second
Participants 57
Sex All
Age 21- 55
Therapy No

Trial Details

A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Relative Bioavailability and Food Effect Cohort to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of CYB003 in Healthy Participants With and Without Major Depressive Disorder (MDD)

NCT Number NCT05385783

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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