Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
260
Countries
1
Sites
1
None. Healthy subjects
Key facts
- Sponsor
- IBSA Institut Biochimique SA
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 May 2025 → 9 Jan 2026
- Decision date (initial)
- 2025-04-04
- 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
None. Healthy subjects
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036376 | Post herpetic neuralgia | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IBSA Institut Biochimique SA
- Sponsor organisation
- IBSA Institut Biochimique SA
- Address
- Via Pian Scairolo 49
- City
- Pazzallo
- Postcode
- 6912
- Country
- Switzerland
Scientific contact point
- Organisation
- IBSA Institut Biochimique SA
- Contact name
- Stefano ROVATI
Public contact point
- Organisation
- IBSA Institut Biochimique SA
- Contact name
- Guiseppe CELIBERTI
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 260 | 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 |
|---|---|---|---|---|---|
| France | 2025-05-12 | 2026-01-09 | 2025-05-12 | 2025-11-28 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-23 | France | Acceptable 2025-04-04
|
2025-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-18 | France | Acceptable 2025-10-14
|
2025-10-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-12 | France | Acceptable 2025-10-14
|
2025-11-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-04 | France | Acceptable 2025-10-14
|
2025-12-04 |