Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
112
Countries
1
Sites
1
Ulcerative colitis
Key facts
- Sponsor
- Granite Bio AG
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507547-11-00
- WHO UTN
- U1111-1290-5105
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ulcerative colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Granite Bio AG
- Sponsor organisation
- Granite Bio AG
- Address
- Aeschenvorstadt 36
- City
- Basel Town
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- Granite Bio AG
- Contact name
- CT information desk
Public contact point
- Organisation
- Granite Bio AG
- Contact name
- CT information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 112 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-02-09 | 2024-02-09 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-12 | Germany | Acceptable 2023-12-22
|
2024-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-31 | Germany | Acceptable 2024-07-09
|
2024-07-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-14 | Germany | Acceptable 2024-07-09
|
2024-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-14 | Germany | Acceptable 2025-04-02
|
2025-04-16 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-04 | Germany | Acceptable 2025-04-02
|
2025-08-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-20 | Germany | Acceptable 2025-09-15
|
2025-09-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-01 | Germany | Acceptable 2025-09-15
|
2025-10-01 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-29 | Germany | Acceptable 2025-12-11
|
2025-12-11 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-13 | Germany | Acceptable 2026-03-10
|
2026-03-13 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-30 | Germany | Acceptable 2026-03-10
|
2026-04-30 |