Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
2
urinary incontinence
Key facts
- Sponsor
- Nicolaus Copernicus University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2024-10-31
- 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
urinary incontinence
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10021643 | Incontinence urinary | 10038359 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nicolaus Copernicus University
- Sponsor organisation
- Nicolaus Copernicus University
- Address
- Ul. Jurija Gagarina 11
- City
- Torun
- Postcode
- 87-100
- Country
- Poland
Scientific contact point
- Organisation
- Nicolaus Copernicus University
- Contact name
- Science and Projects Department
Public contact point
- Organisation
- Nicolaus Copernicus University
- Contact name
- Press office
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 15 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-25 | Poland | Acceptable with conditions 2024-10-29
|
2024-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-27 | Poland | Acceptable 2025-05-16
|
2025-05-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-11 | Acceptable 2025-05-16
|
||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-19 | Poland | Acceptable 2026-04-13
|
2026-04-15 |