Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
24
Countries
1
Sites
1
Antidote
Key facts
- Sponsor
- Eurofins Optimed, Fabentech
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 5 Jan 2024 → 30 Sep 2024
- Decision date (initial)
- 2023-12-20
- 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
Antidote
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10015711 | Exposure to poisonous plant | 10022117 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eurofins Optimed
- Sponsor organisation
- Eurofins Optimed
- Address
- 1 Rue Des Essarts
- City
- Gieres
- Postcode
- 38610
- Country
- France
Scientific contact point
- Organisation
- Eurofins Optimed
- Contact name
- Félix COLLET
Public contact point
- Organisation
- Eurofins Optimed
- Contact name
- Félix COLLET
Fabentech
- Sponsor organisation
- Fabentech
- Address
- Building Tony Garnier, 24 Rue Jean Baldassini 24 Rue Jean Baldassini
- City
- Lyon
- Postcode
- 69007
- Country
- France
Scientific contact point
- Organisation
- Fabentech
- Contact name
- Romane ARLAUD
Public contact point
- Organisation
- Fabentech
- Contact name
- Romane ARLAUD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 24 | 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 | 2024-01-05 | 2024-09-30 | 2024-01-05 | 2024-08-01 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-20 | France | Acceptable with conditions 2023-12-19
|
2023-12-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | France | Acceptable 2023-12-22
|
2023-12-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-16 | France | 2024-03-04 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-05 | France | Acceptable 2024-04-22
|
2024-04-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-24 | France | Acceptable 2024-04-22
|
2024-04-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-04 | France | Acceptable 2024-08-02
|
2024-08-02 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-09 | France | Acceptable 2024-08-29
|
2024-08-30 |