Overview
Sponsor-declared trial summary
Phase I study in healthy participants. Intended indication: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease
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
- 14 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-09
- 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
Phase I study in healthy participants. Intended indication: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease
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
- New drug / Bio RA team
Public contact point
- Organisation
- Chong Kun Dang Pharmaceutical Corp.
- Contact name
- New drug / Bio RA team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 335 | 1 |
| Rest of world
United Kingdom
|
— | 184 | — |
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 | 2026-01-14 | 2026-01-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-29 | Germany | Acceptable 2026-01-07
|
2026-01-09 |