Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
2
Ulcerative colitis
Key facts
- Sponsor
- EnteroTarget ApS
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 4 Feb 2025 → 2 Sep 2025
- Decision date (initial)
- 2024-09-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ulcerative colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10024123 | Left-sided ulcerative (chronic) colitis | 10017947 |
| 20.0 | LLT | 10036789 | Proctosigmoiditis | 10017947 |
| 20.0 | PT | 10036774 | Proctitis | 100000004856 |
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
EnteroTarget ApS
- Sponsor organisation
- EnteroTarget ApS
- Address
- Ole Maaloees Vej 3
- City
- Copenhagen N
- Postcode
- 2200
- Country
- Denmark
Scientific contact point
- Organisation
- EnteroTarget ApS
- Contact name
- Jørgen Olsen
Public contact point
- Organisation
- EnteroTarget ApS
- Contact name
- Jørgen Olsen
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 6 | 2 |
| 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 |
|---|---|---|---|---|---|
| Poland | 2025-02-04 | 2025-09-02 | 2025-04-10 | 2025-08-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-16 | Poland | Acceptable with conditions 2024-09-02
|
2024-09-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Poland | Acceptable 2024-12-20
|
2024-12-23 |