Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
2
renal impairment
Key facts
- Sponsor
- Argenx
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 14 Jul 2023 → 12 Jun 2024
- Decision date (initial)
- 2023-06-20
- 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
renal impairment
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
- Peter Ulrichts
Public contact point
- Organisation
- Argenx
- Contact name
- Peter Ulrichts
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 48 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
APEX Gesellschaft Fur Angewandte Pharmakologie Und Experimentelle Pharmakotherapie mbH
Gesellschaft Fur Angewandte Pharmakologie Und Experimentelle Pharmakotherapie, Landsberger Strasse 476, Pasing-Obermenzing, Munich
CRS Clinical Research Services Management GmbH
Clinical Pharmacology Unit, Board of Managing Directors, Lornsenstrasse 7, Brunswik, Kiel
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 |
|---|---|---|---|---|---|
| Germany | 2023-07-14 | 2024-06-12 | 2023-07-19 | 2024-03-27 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-24 | Germany | Acceptable 2023-06-20
|
2023-06-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-19 | Germany | Acceptable 2023-06-20
|
2023-07-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-12-21 | Germany | Acceptable 2023-06-20
|
2023-12-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-19 | Germany | Acceptable 2024-02-19
|
2024-02-20 |