Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
48
Countries
1
Sites
1
neurological disease
Key facts
- Sponsor
- Ceres Brain Therapeutics
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 21 Feb 2025 → 26 Sep 2025
- Decision date (initial)
- 2025-01-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
neurological disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ceres Brain Therapeutics
- Sponsor organisation
- Ceres Brain Therapeutics
- Address
- 37 Boulevard Berthier
- City
- Paris
- Postcode
- 75017
- Country
- France
Scientific contact point
- Organisation
- Ceres Brain Therapeutics
- Contact name
- Project manager
Public contact point
- Organisation
- Ceres Brain Therapeutics
- Contact name
- Project manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2025-02-21 | 2025-09-26 | 2025-02-21 | 2025-08-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | France | Acceptable 2025-01-15
|
2025-01-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-28 | France | Acceptable | 2025-02-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | France | Acceptable 2025-04-01
|
2025-04-22 |