Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
96
Countries
1
Sites
1
Cognitive impairment
Key facts
- Sponsor
- Vandria SA
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-08-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
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 SA
- Sponsor organisation
- Vandria SA
- Address
- Batiment Epfl Innovation Park
- City
- Lausanne
- Postcode
- 1015
- 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 | Not authorised | 96 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | France | Not acceptable 2024-07-29
|
2024-08-02 |