Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
213
Countries
1
Sites
1
Active psoriatic arthritis
Key facts
- Sponsor
- Chong Kun Dang Pharmaceutical Corp.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 11 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-26
- 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
Active psoriatic arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
| 28.0 | PT | 10011401 | Crohn´s disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chong Kun Dang Pharmaceutical Corp.
- Sponsor organisation
- Chong Kun Dang Pharmaceutical Corp.
- Address
- 8 Chungjeong-Ro
- City
- Seodaemun
- Postcode
- 03742
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Chong Kun Dang Pharmaceutical Corp.
- Contact name
- Soung-Jun Min, M.D.
Public contact point
- Organisation
- Chong Kun Dang Pharmaceutical Corp.
- Contact name
- Eunsu Jung
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 213 | 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 |
|---|---|---|---|---|---|
| Poland | 2025-11-11 | 2025-11-12 | 2026-03-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-03 | Poland | Acceptable 2025-10-20
|
2025-10-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-15 | Poland | Acceptable 2025-10-20
|
2025-12-15 |