Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
81
Countries
1
Sites
1
not applicable
Key facts
- Sponsor
- Argenx
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 4 Dec 2024 → 28 May 2026
- Decision date (initial)
- 2024-12-03
- 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
not applicable
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Argenx
- Sponsor organisation
- Argenx
- Address
- Industriepark-Zwijnaarde 7
- City
- Gent
- Postcode
- 9052
- Country
- Belgium
Scientific contact point
- Organisation
- Argenx
- Contact name
- Chief Scientific Officer
Public contact point
- Organisation
- Argenx
- Contact name
- Vice President Clinical Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 81 | 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 | 2024-12-04 | 2026-05-28 | 2024-12-12 | 2025-12-26 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Belgium | Acceptable with conditions 2024-11-27
|
2024-12-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-21 | Belgium | Acceptable 2025-02-04
|
2025-02-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-10 | Belgium | Acceptable 2025-05-21
|
2025-05-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-26 | Belgium | Acceptable 2025-05-21
|
2025-09-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-28 | Belgium | Acceptable 2026-06-01
|
2026-06-01 |