Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
10
Chronic Graft-versus-Host Disease
Key facts
- Sponsor
- Qurient 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
- 23 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Graft-versus-Host Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10066261 | Chronic graft versus host disease | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Qurient Co. Ltd.
- Sponsor organisation
- Qurient Co. Ltd.
- Address
- C Dong 801 Pdc 242 Pangyo-Ro, Bundang Bundang
- City
- Seongnam
- Postcode
- 13487
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Qurient Co. Ltd.
- Contact name
- Head of Clinical Development
Public contact point
- Organisation
- Qurient Co. Ltd.
- Contact name
- Qurient Co., Ltd.
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 16 | 10 |
| Rest of world
United States
|
— | 2 | — |
Investigational sites
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
Hematology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
University Clinical Hospital Virgen De La Arrixaca
Hematology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Regional De Malaga
Hematology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Spain | 2025-12-23 | 2025-12-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-29 | Spain | Acceptable 2025-11-18
|
2025-11-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-16 | Spain | Acceptable 2025-11-18
|
2025-12-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-17 | Spain | Acceptable | 2026-01-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-23 | Spain | Acceptable | 2026-02-23 |