Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
18
Countries
1
Sites
1
No therapeutic indication in the current trial with healthy volunteers.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 12 Mar 2025 → 15 Apr 2025
- Decision date (initial)
- 2025-02-21
- 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
No therapeutic indication in the current trial with healthy volunteers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager
Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
- Sponsor organisation
- Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
- Address
- Kaliftaki 27
- City
- Kifisia
- Postcode
- 145 64
- Country
- Greece
Scientific contact point
- Organisation
- Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
- Contact name
- Head of RA
Public contact point
- Organisation
- Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
- Contact name
- Head of RA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-03-12 | 2025-04-15 | 2025-03-12 | 2025-03-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-12 | Bulgaria | Acceptable 2025-02-20
|
2025-02-21 |