Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
106
Countries
1
Sites
1
Unipolar depression (UD)
Key facts
- Sponsor
- Delix Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 14 Apr 2023 → 16 Aug 2024
- Decision date (initial)
- 2023-04-12
- 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
Unipolar depression (UD)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Delix Therapeutics Inc.
- Sponsor organisation
- Delix Therapeutics Inc.
- Address
- 20 Authors Road
- City
- Concord
- Postcode
- 01742-2607
- Country
- United States
Scientific contact point
- Organisation
- Delix Therapeutics Inc.
- Contact name
- Head of Research and Development
Public contact point
- Organisation
- Delix Therapeutics Inc.
- Contact name
- Head of Research and Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 106 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre For Human Drug Research
NA, Zernikedreef 8, 2333 CL, Leiden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-04-14 | 2024-08-16 | 2023-04-24 | 2024-07-05 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-27 | Netherlands | Acceptable 2023-04-12
|
2023-04-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-11 | Netherlands | Acceptable 2023-04-12
|
2023-05-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-10 | Netherlands | Acceptable 2023-04-12
|
2023-07-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-07-10 | Netherlands | Acceptable 2023-04-12
|
2023-07-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-08-01 | Netherlands | Acceptable 2023-04-12
|
2023-08-01 |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-09 | Netherlands | Acceptable 2023-08-16
|
2023-08-16 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-08-22 | Netherlands | Acceptable 2023-08-16
|
2023-08-22 |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-25 | Netherlands | Acceptable 2023-08-29
|
2023-08-29 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-07 | Netherlands | Acceptable with conditions 2023-12-15
|
2023-12-15 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2023-12-18 | Netherlands | Acceptable with conditions 2023-12-15
|
2023-12-18 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-31 | Netherlands | Acceptable 2024-02-08
|
2024-02-08 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-15 | Netherlands | Acceptable with conditions 2024-02-29
|
2024-02-29 |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-26 | Netherlands | Acceptable 2024-04-10
|
2024-04-10 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-06-27 | Netherlands | Acceptable 2024-04-10
|
2024-06-27 |