Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Type 2 Diabetes Mellitus
Key facts
- Sponsor
- Gan & Lee Pharmaceuticals USA Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- completed 10 Jun 2025
- Decision date (initial)
- 2025-03-19
- 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
Type 2 Diabetes Mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gan & Lee Pharmaceuticals USA Corp.
- Sponsor organisation
- Gan & Lee Pharmaceuticals USA Corp.
- Address
- 520 Us Highway 22 Suite 302
- City
- Bridgewater
- Postcode
- 08807-2410
- Country
- United States
Scientific contact point
- Organisation
- Gan & Lee Pharmaceuticals USA Corp.
- Contact name
- Olena Kucheruk
Public contact point
- Organisation
- Gan & Lee Pharmaceuticals USA Corp.
- Contact name
- Olena Kucheruk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-24 | Germany | Acceptable 2025-03-17
|
2025-03-19 |