Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
1
Phase I trial, healthy volunteers
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2025-02-04
- 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
Phase I trial, healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Varsinais-Suomen hyvinvointialue
- Sponsor organisation
- Varsinais-Suomen hyvinvointialue
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Juha Rinne
Public contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Juha Rinne
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Finland | Acceptable with conditions 2025-01-30
|
2025-02-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-05 | Finland | Acceptable with conditions 2025-01-30
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-17 | Finland | Acceptable 2025-03-05
|
2025-03-07 |