Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
89
Countries
1
Sites
1
Women infertility
Key facts
- Sponsor
- Freya Biosciences ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 13 Feb 2025 → 6 Jan 2026
- Decision date (initial)
- 2025-02-06
- 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
Women infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10021926 | Infertility | 100000004872 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Freya Biosciences ApS
- Sponsor organisation
- Freya Biosciences ApS
- Address
- Fruebjergvej 3
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Freya Biosciences ApS
- Contact name
- Clinical Department
Public contact point
- Organisation
- Freya Biosciences ApS
- Contact name
- Clinical Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 89 | 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 |
|---|---|---|---|---|---|
| Germany | 2025-02-13 | 2026-01-06 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-30 | Germany | Acceptable 2025-01-29
|
2025-02-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-29 | Germany | Acceptable 2025-01-29
|
2025-04-29 |