Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
2
Countries
1
Sites
1
Diabetes type I
Key facts
- Sponsor
- Uppsala University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 8 Mar 2024 → ongoing
- Decision date (initial)
- 2023-11-16
- 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
Diabetes type I
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045228 | Type I diabetes mellitus | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uppsala University Hospital
- Sponsor organisation
- Uppsala University Hospital
- Address
- Akademiska Sjukhuset
- City
- Uppsala
- Postcode
- 751 85
- Country
- Sweden
Scientific contact point
- Organisation
- Uppsala University Hospital
- Contact name
- Per-Ola Carlsson
Public contact point
- Organisation
- Uppsala University Hospital
- Contact name
- Per-Ola Carlsson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 2 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-03-08 | 2024-12-01 | 2025-10-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-04 | Sweden | Acceptable 2023-11-13
|
2023-11-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-03 | Sweden | Acceptable 2024-05-20
|
2024-05-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-10 | Sweden | Acceptable 2026-01-30
|
2026-01-30 |