Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
76
Countries
1
Sites
2
No therapeutic indication in the current trial with healthy volunteers. The intended indication is for treatment of adult patients with highly active relapsing multiple sclerosis (MS).
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Pharos Pharmaceutical Oriented Services Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Mar 2024 → 2 May 2024
- Decision date (initial)
- 2024-02-06
- 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. The intended indication is for treatment of adult patients with highly active relapsing multiple sclerosis (MS).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10039720 | Sclerosis multiple | 10029205 |
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
- Lindenallee 70, Dahlwitz-Hoppegarten Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova
Pharos Pharmaceutical Oriented Services Ltd.
- Sponsor organisation
- Pharos Pharmaceutical Oriented Services Ltd.
- Address
- Lesvou Street End, Thesi Loggos Industrial Zone Thesi Loggos Industrial Zone
- City
- Metamorfossi
- Postcode
- 144 52
- Country
- Greece
Public contact point
- Organisation
- Pharos Pharmaceutical Oriented Services Ltd.
- Contact name
- Fotini Samara
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 76 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Clinic of Clinical Pharmacology and Therapeutics at UMHAT 'Tsaritsa Ioanna-ISUL' EAD
Clinic of Clinical Pharmacology and Therapeutics, 8 'Bialo more' Str., 1504, Sofia
Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
Bed space for short term stay, 47 'Bacho Kiro' str., 1202, Sofia
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 | 2024-03-01 | 2024-05-02 | 2024-03-01 | 2024-03-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Bulgaria | Acceptable 2024-02-01
|
2024-02-06 |