Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
10
Countries
1
Sites
1
Head and neck carcinoma
Key facts
- Sponsor
- HUS-Yhtymae, Neutron Therapeutics Finland Oy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 15 Apr 2025 → 16 Apr 2026
- Decision date (initial)
- 2024-10-16
- 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
Head and neck carcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Anu Anttonen
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Anu Anttonen
Neutron Therapeutics Finland Oy
- Sponsor organisation
- Neutron Therapeutics Finland Oy
- Address
- Kanavaranta 9
- City
- Helsinki
- Postcode
- 00160
- Country
- Finland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 10 | 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 | 2025-04-15 | 2026-04-16 | 2025-04-25 | 2026-03-12 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Finland | Acceptable 2024-10-08
|
2024-10-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-25 | Finland | Acceptable 2024-10-08
|
2025-03-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-21 | Finland | Acceptable 2024-10-08
|
2026-04-21 |