Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
68
Countries
1
Sites
1
neuropathic pain
Key facts
- Sponsor
- University Of Pecs
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519485-50-00
- EudraCT number
- 2021-001804-13
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
neuropathic pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Pecs
- Sponsor organisation
- University Of Pecs
- Address
- Vasvari Pal Utca 4
- City
- Pecs
- Postcode
- 7622
- Country
- Hungary
Scientific contact point
- Organisation
- University Of Pecs
- Contact name
- Zsuzsanna Helyes
Public contact point
- Organisation
- University Of Pecs
- Contact name
- Zsuzsanna Helyes
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruiting | 68 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
DRC Kft.
Phase I, Gyogy ter 2., 8230, Balatonfured
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 |
|---|---|---|---|---|---|
| Hungary | 2024-11-25 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-06 | Hungary | Acceptable with conditions 2024-11-25
|
2024-11-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-14 | Hungary | Acceptable 2025-01-15
|
2025-01-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-27 | Hungary | Acceptable 2025-03-17
|
2025-04-16 |