Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
1
Bladder cancer
Key facts
- Sponsor
- Region Sjaelland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2026-526388-39-00
- ClinicalTrials.gov
- NCT07555769
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Bladder cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10046585 | Urinary tract neoplasms malignant NEC | 10029104 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 28.0 | SOC | 10038359 | Renal and urinary disorders | 18 |
| 20.0 | HLGT | 10038364 | Renal and urinary tract neoplasms malignant and unspecified | 10029104 |
| 28.1 | HLT | 10005013 | Bladder neoplasms malignant | 10029104 |
| 20.0 | HLT | 10046586 | Urinary tract neoplasms unspecified malignancy NEC | 10029104 |
| 20.0 | HLT | 10005058 | Bladder neoplasms | 10038359 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Sjaelland
- Sponsor organisation
- Region Sjaelland
- Address
- Sygehusvej 10
- City
- Roskilde
- Postcode
- 4000
- Country
- Denmark
Scientific contact point
- Organisation
- Region Sjaelland
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Region Sjaelland
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 20 | 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 | 2026-04-15 | Denmark | Acceptable 2026-07-03
|
2026-07-03 |