Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
75
Countries
1
Sites
1
Rift Valley fever (RVF) infection
Key facts
- Sponsor
- Cr2o B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Jul 2022 → ongoing
- Decision date (initial)
- 2022-07-26
- 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
Rift Valley fever (RVF) infection
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cr2o B.V.
- Sponsor organisation
- Cr2o B.V.
- Address
- Bisonspoor 3002 C 701
- City
- Maarssen
- Postcode
- 3605 LT
- Country
- Netherlands
Scientific contact point
- Organisation
- Cr2o B.V.
- Contact name
- Bart Hendriks
Public contact point
- Organisation
- Cr2o B.V.
- Contact name
- Bart Hendriks
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 75 | 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 | 2022-07-26 | 2022-08-01 | 2022-12-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-21 | Belgium | Acceptable 2022-07-26
|
2022-07-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-13 | Belgium | Acceptable 2023-08-11
|
2023-08-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-21 | Belgium | Acceptable 2022-07-26
|
2023-09-21 |