Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Androgenetic alopecia
Key facts
- Sponsor
- Industrial Farmaceutica Cantabria S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 1 Feb 2024 → 1 Mar 2024
- Decision date (initial)
- 2023-10-20
- 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
Androgenetic alopecia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Industrial Farmaceutica Cantabria S.A.
- Sponsor organisation
- Industrial Farmaceutica Cantabria S.A.
- Address
- Barrio Solia N 30, Liano Liano
- City
- Villaescusa
- Postcode
- 39690
- Country
- Spain
Scientific contact point
- Organisation
- Industrial Farmaceutica Cantabria S.A.
- Contact name
- Ana López Ballesteros
Public contact point
- Organisation
- Industrial Farmaceutica Cantabria S.A.
- Contact name
- Ana López Ballesteros
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 14 | 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 |
|---|---|---|---|---|---|
| Spain | 2024-02-01 | 2024-03-01 | 2024-02-02 | 2024-02-09 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-07 | Spain | Acceptable with conditions 2023-10-20
|
2023-10-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-14 | Spain | Acceptable with conditions 2024-01-26
|
2024-01-26 |