Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
1
Osteoarthritis
Key facts
- Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 7 Jan 2026 → ongoing
- Decision date (initial)
- 2025-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517421-12-00
- WHO UTN
- U1111-1317-3338
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Osteoarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10023476 | Knee osteoarthritis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Charite Universitaetsmedizin Berlin KöR
- Sponsor organisation
- Charite Universitaetsmedizin Berlin KöR
- Address
- Chariteplatz 1, Mitte Mitte
- City
- Berlin
- Postcode
- 10117
- Country
- Germany
Scientific contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Trial centre
Public contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Trial centre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 18 | 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 | 2026-01-07 | 2026-01-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Germany | Acceptable 2025-05-30
|
2025-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-14 | Germany | Acceptable 2026-05-07
|
2026-05-08 |