Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
84
Countries
1
Sites
1
Moderate to severe pain
Key facts
- Sponsor
- Biodol Therapeutics
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Nov 2024 → 19 Feb 2026
- Decision date (initial)
- 2024-11-08
- 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
Moderate to severe pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biodol Therapeutics
- Sponsor organisation
- Biodol Therapeutics
- Address
- 165 Rue Denis Papin
- City
- Montarnaud
- Postcode
- 34570
- Country
- France
Scientific contact point
- Organisation
- Biodol Therapeutics
- Contact name
- Pierre SOKOLOFF
Public contact point
- Organisation
- Biodol Therapeutics
- Contact name
- Pierre SOKOLOFF
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 84 | 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 | 2024-11-25 | 2026-02-19 | 2024-11-25 | 2026-02-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | France | Acceptable 2024-11-08
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-07 | France | Acceptable 2025-04-16
|
2025-05-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-30 | France | Acceptable 2025-10-22
|
2025-10-22 |