Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
1
Sites
1
Psychatric disorder
Key facts
- Sponsor
- Eurofins Optimed, Synendos Therapeutics AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Feb 2024 → 21 Oct 2024
- Decision date (initial)
- 2024-01-15
- 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
Psychatric disorder
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
- Synendos Therapeutics AG
- Contact name
- Andrea Chicca
Public contact point
- Organisation
- Synendos Therapeutics AG
- Contact name
- Andrea Chicca
Synendos Therapeutics AG
- Sponsor organisation
- Synendos Therapeutics AG
- Address
- Barfusserplatz 3
- City
- Basel Town
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- Synendos Therapeutics AG
- Contact name
- Andrea CHICCA
Public contact point
- Organisation
- Synendos Therapeutics AG
- Contact name
- Andrea CHICCA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 72 | 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 | 2024-02-05 | 2024-10-21 | 2024-02-05 | 2024-10-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-14 | France | Acceptable 2023-12-18
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | France | Acceptable 2024-07-01
|
2024-07-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-04 | France | Acceptable 2024-07-01
|
2024-09-04 |