Trials / Completed
CompletedNCT05385783
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Cybin IRL Limited · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYB003 | CYB003 is a synthetic psilocybin analog. |
| BEHAVIORAL | Psychotherapy | Manualized psychotherapy (called EMBARK) performed by facilitators |
| DRUG | Placebo | Placebo |
| BEHAVIORAL | Psychological Support | Manualized psychological support performed by facilitators |
Timeline
- Start date
- 2022-08-02
- Primary completion
- 2023-10-16
- Completion
- 2024-01-18
- First posted
- 2022-05-23
- Last updated
- 2024-03-25
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05385783. Inclusion in this directory is not an endorsement.