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NCT05385783 · ClinicalTrials.gov registry record · Phase 1
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
A Phase 1 study, sponsored by Cybin IRL Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT05385783: Completed Phase 1 study, sponsored by Cybin IRL Limited.
NCT05385783 is a Phase 1 study that has completed, run by Cybin IRL Limited. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05385783, a Phase 1 study, has completed, sponsored by Cybin IRL Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study 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).
Primary Outcome
Any untoward medical occurrence in a clinical investigation participant administered a drug and does not necessarily have a causal relationship with the treatment
Interventions
- DRUG Placebo
- BEHAVIORAL Psychotherapy
- DRUG CYB003
- BEHAVIORAL Psychological Support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2024-01-18 |
| Phase | Phase 1 |
What the finished NCT05385783 record still lists
NCT05385783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05385783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05385783 about?
NCT05385783 is a clinical study titled "A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder". 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).
What is the current status of trial NCT05385783?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2022-08-02. Estimated completion is 2024-01-18.
What interventions are being tested in trial NCT05385783?
The interventions under investigation include: Placebo (DRUG), Psychotherapy (BEHAVIORAL), CYB003 (DRUG), Psychological Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT05385783?
This trial is sponsored by Cybin IRL Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05385783's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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