Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
10
Countries
1
Sites
1
Distal radius fractures
Key facts
- Sponsor
- Novadip Biosciences
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 8 Aug 2023 → 19 Dec 2024
- Decision date (initial)
- 2024-01-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508321-27-00
- EudraCT number
- 2022-002304-21
- ClinicalTrials.gov
- NCT05987033
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Distal radius fractures
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novadip Biosciences
- Sponsor organisation
- Novadip Biosciences
- Address
- Rue Granbonpre 11
- City
- Mont-Saint-Guibert
- Postcode
- 1435
- Country
- Belgium
Scientific contact point
- Organisation
- Novadip Biosciences
- Contact name
- Denis Dufrane
Public contact point
- Organisation
- Novadip Biosciences
- Contact name
- Denis Dufrane
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Luxembourg | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier de Luxembourg
Orthopedics and traumatology, rue Ernest Barblé 4, L-1210, Luxembourg
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 |
|---|---|---|---|---|---|
| Luxembourg | 2023-08-08 | 2024-12-19 | 2023-08-08 | 2023-12-20 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | Luxembourg | Acceptable 2024-01-17
|
2024-01-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-10 | Luxembourg | Acceptable 2025-02-10
|
2025-02-11 |