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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT05385783

Public ClinicalTrials.gov record NCT05385783. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT05385783
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Cybin IRL Limited
Industry
Enrollment
57 participants

Conditions and interventions

Interventions

  • CYB003 Drug
  • Psychotherapy Behavioral
  • Placebo Drug
  • Psychological Support Behavioral

Drug · Behavioral

Eligibility (public fields only)

Age range
21 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2022
Primary completion
Oct 15, 2023
Completion
Jan 17, 2024
Last update posted
Mar 24, 2024

2022 – 2024

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
CenExel ACMR Atlanta Georgia 30331
iResearch Atlanta Decatur Georgia 30030
Clinilabs Drug Development Corporation Eatontown New Jersey 07724

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05385783, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 24, 2024 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05385783 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →