Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Healthy female participants of childbearing potential.
Key facts
- Sponsor
- Abivax
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Oct 2023 → 31 Aug 2024
- Decision date (initial)
- 2023-08-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy female participants of childbearing potential.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
| 20.1 | PT | 10021972 | Inflammatory bowel disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abivax
- Sponsor organisation
- Abivax
- Address
- 7 Boulevard Haussmann
- City
- Paris
- Postcode
- 75009
- Country
- France
Scientific contact point
- Organisation
- Abivax
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Abivax
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 36 | 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 | 2023-10-10 | 2024-08-31 | 2024-08-01 | 2024-08-15 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-30 | Belgium | Acceptable with conditions 2023-08-09
|
2023-08-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-10-05 | Belgium | Acceptable with conditions 2023-08-09
|
2023-10-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-17 | Belgium | Acceptable with conditions 2024-05-29
|
2024-05-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-06 | Belgium | Acceptable with conditions | 2024-06-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-07-17 | Belgium | Acceptable with conditions | 2024-07-17 |