Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
8
Countries
1
Sites
3
mild-to-moderate active ulcerative colitis
Key facts
- Sponsor
- Liveome Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-11-18
- 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
mild-to-moderate active 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
Liveome Inc.
- Sponsor organisation
- Liveome Inc.
- Address
- 2F 114 Central town-Ro, Yeongtong-Gu Yeongtong-Gu
- City
- Suwon-Si
- Postcode
- 16506
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Liveome Inc.
- Contact name
- Sophie Hyun-Ja Ko
Public contact point
- Organisation
- Liveome Inc.
- Contact name
- Sophie Hyun-Ja Ko
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 8 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Poland | Acceptable with conditions 2024-11-12
|
2024-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-08 | Poland | Acceptable 2025-02-24
|
2025-03-02 |