Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
48
Countries
1
Sites
1
Men and women infertility
Key facts
- Sponsor
- Igyxos
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 22 Sep 2023 → 25 Jul 2025
- Decision date (initial)
- 2023-09-15
- 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
Men and women infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10021929 | Infertility male | 100000004872 |
| 20.0 | PT | 10021928 | Infertility female | 100000004872 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Igyxos
- Sponsor organisation
- Igyxos
- Address
- Centre Inrae Val De Loire
- City
- Nouzilly
- Postcode
- 37380
- Country
- France
Scientific contact point
- Organisation
- Igyxos
- Contact name
- Clinical Department
Public contact point
- Organisation
- Igyxos
- Contact name
- Clinical Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 48 | 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 | 2023-09-22 | 2025-07-25 | 2023-09-25 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-06 | Germany | Acceptable with conditions 2023-09-14
|
2023-09-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-15 | Germany | Acceptable with conditions 2023-09-14
|
2023-09-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-20 | Germany | Acceptable 2024-01-15
|
2024-01-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-01 | Germany | Acceptable 2024-04-18
|
2024-04-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-18 | Germany | Acceptable 2024-04-18
|
2024-06-18 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-08-01 | Germany | Acceptable 2024-04-18
|
2024-08-01 |