Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
12
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 4 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-525059-23-00
- ClinicalTrials.gov
- NCT07300670
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
- Turku University Hospital, Unit of Clinical Pharmacology
Public contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Turku University Hospital, Unit of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruitment ended | 12 | 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 |
|---|---|---|---|---|---|
| Finland | 2026-03-04 | 2026-03-04 | 2026-03-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-01 | Finland | Acceptable 2026-02-25
|
2026-02-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-14 | Finland | Acceptable 2026-02-25
|
2026-04-14 |