Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Not authorised
Participants planned
48
Countries
1
Sites
1
Functional female infertility
Key facts
- Sponsor
- Xentria Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2026-03-23
- 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
Functional female infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10021926 | Infertility | 100000004872 |
| 20.0 | PT | 10021928 | Infertility female | 100000004872 |
| 27.1 | LLT | 10016398 | Female infertility | 10038604 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Xentria Inc.
- Sponsor organisation
- Xentria Inc.
- Address
- 2032 North Clybourn Avenue Suite 100
- City
- Chicago
- Postcode
- 60614-4051
- Country
- United States
Scientific contact point
- Organisation
- Xentria Inc.
- Contact name
- Tom Matthews
Public contact point
- Organisation
- Xentria Inc.
- Contact name
- Noopur Singh
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Not authorised | 48 | 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 | 2025-11-13 | Poland | Not acceptable 2026-03-16
|
2026-03-23 |