Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
96
Countries
1
Sites
1
Cognitive impairment
Key facts
- Sponsor
- Vandria S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 19 Nov 2024 → 12 Nov 2025
- Decision date (initial)
- 2024-11-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512106-26-02
- ClinicalTrials.gov
- NCT06721091
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cognitive impairment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009846 | Cognitive impairment | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vandria S.A.
- Sponsor organisation
- Vandria S.A.
- Address
- Route De La Corniche 8
- City
- Epalinges
- Postcode
- 1066
- Country
- Switzerland
Scientific contact point
- Organisation
- Vandria SA
- Contact name
- Chief Executive Officer
Public contact point
- Organisation
- Vandria SA
- Contact name
- Chief Executive Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 96 | 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 | 2024-11-19 | 2025-11-12 | 2024-12-02 | 2025-11-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-09-17
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | France | Acceptable 2024-11-15
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-10 | France | Acceptable 2025-04-04
|
2025-04-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-04 | France | Acceptable 2025-07-18
|
2025-07-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-17 | France | Acceptable | 2025-09-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-10 | France | Acceptable | 2025-10-10 |