Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
30
Countries
1
Sites
1
not applicable (submitted trial is a bioavailability study in healthy subjects)
Key facts
- Sponsor
- Dermax
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 18 Oct 2024 → 3 Nov 2024
- Decision date (initial)
- 2024-09-13
- 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
not applicable (submitted trial is a bioavailability study in healthy subjects)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10047438 | Viral infectious disorders | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dermax
- Sponsor organisation
- Dermax
- Address
- Boulev. De Patience Et Beajonc 3 Box 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Dermax
- Contact name
- Christophe Lyssens
Public contact point
- Organisation
- Dermax
- Contact name
- Christophe Lyssens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 30 | 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 |
|---|---|---|---|---|---|
| Czechia | 2024-10-18 | 2024-11-03 | 2024-10-18 | 2024-10-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Czechia | Acceptable 2024-09-06
|
2024-09-13 |