Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
18
Countries
1
Sites
1
adjunctive neuropathic pain
Key facts
- Sponsor
- Tetra Pharm Technologies ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-10-29
- 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
adjunctive neuropathic pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tetra Pharm Technologies ApS
- Sponsor organisation
- Tetra Pharm Technologies ApS
- Address
- Soendre Jernbanevej 11-13
- City
- Hilleroed
- Postcode
- 3400
- Country
- Denmark
Scientific contact point
- Organisation
- Tetra Pharm Technologies ApS
- Contact name
- Kirsten Harting
Public contact point
- Organisation
- Tetra Pharm Technologies ApS
- Contact name
- Martin Rose
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Germany | Acceptable with conditions 2024-10-23
|
2024-10-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-24 | Germany | Acceptable 2025-02-19
|
2025-02-20 |