Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
9
Countries
1
Sites
1
Type 2 diabetes
Key facts
- Sponsor
- Nanexa AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2024-02-21
- 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 2 diabetes
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nanexa AB
- Sponsor organisation
- Nanexa AB
- Address
- Virdings Alle 2, Vaksala Vaksala
- City
- Uppsala
- Postcode
- 754 50
- Country
- Sweden
Scientific contact point
- Organisation
- Nanexa AB
- Contact name
- Head office
Public contact point
- Organisation
- Nanexa AB
- Contact name
- Head office
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Not authorised | 9 | 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 | 2023-12-04 | Germany | Not acceptable 2024-02-15
|
2024-02-21 |