Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Androgenetic alopecia
Key facts
- Sponsor
- Bioresearch Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-04-29
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10068168 | Androgenetic alopecia | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioresearch Pharma S.A.
- Sponsor organisation
- Bioresearch Pharma S.A.
- Address
- Ul. Zygmunta Glogera 2/11
- City
- Warsaw
- Postcode
- 02-051
- Country
- Poland
Scientific contact point
- Organisation
- Bioresearch Pharma S.A.
- Contact name
- Maciej Wierzbicki
Public contact point
- Organisation
- Bioresearch Pharma S.A.
- Contact name
- Maciej Wierzbicki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-19 | Poland | Acceptable 2026-04-27
|
2026-04-29 |