Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
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]
- Trial duration
- 26 Feb 2025 → 5 May 2025
- Decision date (initial)
- 2024-05-15
- 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 | Ended | 12 | 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 | 2024-05-27 | 2025-05-05 | 2024-05-27 | 2025-05-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-56437
- Halt date
- 2024-11-04
- Member states concerned
- Germany
- Publication date
- 2024-11-08
- Reason
- Sponsor decision
- Explanation
- A substantial modification might be implemented to continue the trial with another cohort. The decision is pending.
- Follow-up measures
- not applicable
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-05 | Germany | Acceptable 2024-05-14
|
2024-05-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-19 | Germany | Acceptable 2024-05-14
|
2024-09-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Germany | Acceptable 2025-01-24
|
2025-01-24 |