Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
24
Countries
1
Sites
1
Not applicable for phase I study
Key facts
- Sponsor
- Gruenenthal GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 5 Jan 2026 → ongoing
- Decision date (initial)
- 2025-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523587-20-00
- WHO UTN
- U1111-1325-3397
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable for phase I study
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gruenenthal GmbH
- Sponsor organisation
- Gruenenthal GmbH
- Address
- Zieglerstrasse 6
- City
- Aachen
- Postcode
- 52078
- Country
- Germany
Scientific contact point
- Organisation
- Gruenenthal GmbH
- Contact name
- Grünenthal Trial Information Desk
Public contact point
- Organisation
- Gruenenthal GmbH
- Contact name
- Grünenthal Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 24 | 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 |
|---|---|---|---|---|---|
| France | 2026-01-05 | 2026-01-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-09 | France | Acceptable 2025-12-19
|
2025-12-19 |