Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
120
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Argenx
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 5 Jun 2025 → 5 Feb 2026
- Decision date (initial)
- 2025-05-30
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10021428 | Immune system disorders | 4 |
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 |
|---|---|---|---|
| Netherlands | Ended | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-06-05 | 2026-02-05 | 2025-06-10 | 2026-02-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-07 | Netherlands | Acceptable 2025-05-30
|
2025-05-30 |