Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
72
Countries
1
Sites
1
Depression and anxiety disorders
Key facts
- Sponsor
- Cybin IRL Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 26 Jun 2024
- Decision date (initial)
- 2023-12-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Depression and anxiety disorders
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cybin IRL Limited
- Sponsor organisation
- Cybin IRL Limited
- Address
- One Spencer Dock, Spencer Dock Spencer Dock
- City
- Dublin 1
- Postcode
- DO1 X9R7
- Country
- Ireland
Scientific contact point
- Organisation
- Cybin IRL Limited
- Contact name
- A. House-Gecewicz
Public contact point
- Organisation
- Cybin IRL Limited
- Contact name
- A. House-Gecewicz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Psychiatry, Zernikedreef 8, 2333 CL, Leiden
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-23 | Netherlands | Acceptable 2023-12-14
|
2023-12-14 |