Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
80
Countries
1
Sites
1
Fragile X syndrome
Key facts
- Sponsor
- Kaerus Bioscience Limited
- 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
- 10 Jul 2024 → 26 Dec 2024
- Decision date (initial)
- 2024-06-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Fragile X syndrome
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kaerus Bioscience Limited
- Sponsor organisation
- Kaerus Bioscience Limited
- Address
- 2nd Floor, 168 Shoreditch High Street 168 Shoreditch High Street
- City
- London
- Postcode
- E1 6RA
- Country
- United Kingdom
Scientific contact point
- Organisation
- Kaerus Bioscience Limited
- Contact name
- Robert Ring
Public contact point
- Organisation
- Kaerus Bioscience Limited
- Contact name
- Marc Ceusters
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 80 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-10 | 2024-12-26 | 2024-07-12 | 2024-12-10 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Belgium | Acceptable with conditions 2024-06-14
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-20 | Belgium | Acceptable 2024-07-09
|
2024-07-10 |