Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Innovative Molecules GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 14 Feb 2025 → 16 Apr 2025
- Decision date (initial)
- 2025-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Innovative Molecules GmbH
- Sponsor organisation
- Innovative Molecules GmbH
- Address
- Lipowskystrasse 10, Sendling Sendling
- City
- Munich
- Postcode
- 81373
- Country
- Germany
Scientific contact point
- Organisation
- Innovative Molecules GmbH
- Contact name
- Company management
Public contact point
- Organisation
- Innovative Molecules GmbH
- Contact name
- Company management
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-02-14 | 2025-04-16 | 2025-02-24 | 2025-03-19 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Bulgaria | Acceptable 2025-02-07
|
2025-02-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-11 | Bulgaria | Acceptable 2025-02-07
|
2025-02-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-13 | Bulgaria | Acceptable 2025-02-07
|
2025-02-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-21 | Bulgaria | Acceptable 2025-04-04
|
2025-04-07 |