Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
48
Countries
1
Sites
7
Health Participants
Key facts
- Sponsor
- ANRS Maladies Infectieuses Emergentes
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 17 Jun 2025 → ongoing
- Decision date (initial)
- 2025-04-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516767-92-01
- ClinicalTrials.gov
- NCT07113106
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Health Participants
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ANRS Maladies Infectieuses Emergentes
- Sponsor organisation
- ANRS Maladies Infectieuses Emergentes
- Address
- 101 Rue De Tolbiac
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- ANRS Maladies Infectieuses Emergentes
- Contact name
- Sabrina ALOUI
Public contact point
- Organisation
- ANRS Maladies Infectieuses Emergentes
- Contact name
- Yazdan YAZDANPANAH
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 48 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Of Clermont-Ferrand
CIC1405, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
CHU Henri Mondor
Service d'immunologie clinique et maladies infectieuses, 1 Rue Gustave Eiffel, Maladies Infectieuses & U2TI, Creteil
Centre Hospitalier Universitaire De Caen Normandie
Centre de recherche clinique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Nantes
CIC1413, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
CIC 14036 Institut Coeur Poumon, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hôpital Cochin
CIC 1417 Cochin Pasteur, 27 rue du Fbg St Jacques, 75014, Paris
Hopital Saint Louis
CIC1427, 1 Avenue Claude Vellefaux, 75010, Paris
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 | 2025-06-17 | 2025-06-18 | 2026-04-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-17 | France | Acceptable 2025-04-22
|
2025-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-16 | France | Acceptable 2025-11-28
|
2025-12-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-29 | France | Acceptable | 2026-03-23 |