Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
28
Countries
1
Sites
1
not applicable (submitted trial is a pharmacokinetic study in healthy subjects)
Key facts
- Sponsor
- ReproNovo 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
- 17 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-09
- 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
not applicable (submitted trial is a pharmacokinetic study in healthy subjects)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ReproNovo ApS
- Sponsor organisation
- ReproNovo ApS
- Address
- Amagerfaelledvej 106
- City
- Copenhagen S
- Postcode
- 2300
- Country
- Denmark
Scientific contact point
- Organisation
- ReproNovo ApS
- Contact name
- ReproNovo Aps (contact)
Public contact point
- Organisation
- ReproNovo ApS
- Contact name
- ReproNovo Aps (contact)
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 28 | 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 | 2026-02-17 | 2026-02-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-18 | Czechia | Acceptable 2026-01-09
|
2026-01-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-21 | Czechia | Acceptable 2026-01-09
|
2026-05-21 |