Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
5
Bacterial urinary infection
Key facts
- Sponsor
- Phagenix
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2024-05-06
- 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
Bacterial urinary infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029279 | Neurogenic bladder | 100000004857 |
| 20.0 | PT | 10054088 | Urinary tract infection bacterial | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Phagenix
2
Total trials
Commercial
- Sponsor organisation
- Phagenix
- Address
- 60 Avenue Rockefeller
- City
- Lyon
- Postcode
- 69008
- Country
- France
Scientific contact point
- Organisation
- Phagenix
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Phagenix
- Contact name
- Chief Medical Officer
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 36 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Bicetre Hospital
Clinical pharmacology - CRC, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Nantes
Urology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Rennes
Urology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nimes
Infectious deseases, Place Du Professeur Robert Debre, 30900, Nimes
Raymond Poincare Hospital
Infectious deseases, 104 Boulevard Raymond Poincare, 92380, Garches
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 |
|---|---|---|---|---|---|
| France |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-08 | France | Acceptable with conditions 2024-04-29
|
2024-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-23 | France | Acceptable 2026-04-27
|
2026-05-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-05-11 | France | Acceptable 2026-05-21
|
2026-05-21 |