Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
68
Countries
1
Sites
1
Fragile X syndrome
Key facts
- Sponsor
- Connecta Therapeutics S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 23 Jun 2023 → 11 Nov 2024
- Decision date (initial)
- 2023-05-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Fragile X syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10017324 | Fragile X syndrome | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Connecta Therapeutics S.L.
- Sponsor organisation
- Connecta Therapeutics S.L.
- Address
- Calle Baldiri Reixac 10-12, Poligono Industrial Parc Cientific De Barcelona Poligono Industrial Parc Cientific De Barcelona
- City
- Barcelona
- Postcode
- 08028
- Country
- Spain
Scientific contact point
- Organisation
- Connecta Therapeutics S.L.
- Contact name
- Josep Prous
Public contact point
- Organisation
- Connecta Therapeutics S.L.
- Contact name
- Jordi Fabrega
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 68 | 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 |
|---|---|---|---|---|---|
| Spain | 2023-06-23 | 2024-11-11 | 2023-06-26 | 2024-09-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-05 | Spain | Acceptable 2023-05-17
|
2023-05-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-26 | Spain | Acceptable 2024-02-28
|
2024-02-29 |