Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
1
Type 1 diabetes
Key facts
- Sponsor
- Samchundang Pharm. Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 29 May 2026 → ongoing
- Decision date (initial)
- 2026-05-28
- 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
Type 1 diabetes
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Samchundang Pharm. Co. Ltd.
- Sponsor organisation
- Samchundang Pharm. Co. Ltd.
- Address
- 351 Hyoryeong-Ro, Seocho-Gu Seocho-Gu
- City
- Seoul
- Postcode
- 06643
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Samchundang Pharm. Co. Ltd.
- Contact name
- Global Business Development HQ
Public contact point
- Organisation
- Samchundang Pharm. Co. Ltd.
- Contact name
- Global Business Development HQ
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 16 | 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 |
|---|---|---|---|---|---|
| Germany | 2026-05-29 | 2026-05-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-18 | Germany | Acceptable 2026-05-18
|
2026-05-28 |