Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
39
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- Institut National De La Sante Et De La Recherche Medicale
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 5 Apr 2024 → ongoing
- Decision date (initial)
- 2023-04-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502871-49-00
- ClinicalTrials.gov
- NCT06024421
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut National De La Sante Et De La Recherche Medicale
- Sponsor organisation
- Institut National De La Sante Et De La Recherche Medicale
- Address
- 101 Rue De Tolbiac
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Pr Denis MALVY
Public contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Pr Xavier DUVAL
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 39 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Centre d'Investigation Clinique 1425, 46 Rue Henri Huchard, 75877, Paris Cedex 18
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 | 2024-04-05 | 2024-05-14 | 2025-11-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-127898
- Halt date
- 2025-11-12
- Planned restart
- 2026-07-27
- Member states concerned
- France
- Publication date
- 2026-04-08
- Reason
- Feasibility (recruitment issues etc.)
- Explanation
- The shelf life of the experimental drug’s tablets was November 30, 2026. Since negotiations with the drug’s license holder did not result in the receipt of a new batch before that date, patient enrollment has been suspended. Negotiations are ongoing, and an amendment is currently being drafted.
- Follow-up measures
- Participant follow-up in accordance with the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-19 | France | Acceptable 2023-04-25
|
2023-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-05 | France | Acceptable 2024-12-24
|
2024-12-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-07 | France | Acceptable 2025-04-02
|
2025-04-03 |