Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
45
Countries
1
Sites
2
Rheumatoid arthritis
Key facts
- Sponsor
- Ilab Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 7 Jun 2024 → 15 Oct 2025
- Decision date (initial)
- 2024-05-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510247-38-00
- ClinicalTrials.gov
- NCT05533372
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ilab Co. Ltd.
- Sponsor organisation
- Ilab Co. Ltd.
- Address
- 9-22 Pangyoro255beon-Gil, Bundang Bundang
- City
- Seongnam
- Postcode
- 13486
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Ilab Co. Ltd.
- Contact name
- Taegwon Oh
Public contact point
- Organisation
- Ilab Co. Ltd.
- Contact name
- Taegwon Oh
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 35 | 2 |
| Rest of world
United States
|
— | 10 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, 1st floor, wards 33, 34, and 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
ARENSIA Clinics S.R.L., 3rd floor-, and wards 1, 2, 3, 4, 5, 6 and 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
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 |
|---|---|---|---|---|---|
| Romania | 2024-06-07 | 2025-10-15 | 2024-06-07 | 2025-09-11 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-07 | Romania | Acceptable with conditions 2024-05-20
|
2024-05-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-26 | Romania | No conclusion 2024-08-12
|
2024-08-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-18 | Romania | No conclusion 2024-08-12
|
2024-11-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-31 | Romania | Acceptable 2025-03-17
|
2025-03-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-17 | Romania | Acceptable 2025-03-17
|
2025-09-17 |