Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
132
Countries
1
Sites
1
Not applicable, Healthy Volunteers
Key facts
- Sponsor
- Mabxience Research S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 12 Feb 2024 → 4 Jun 2025
- Decision date (initial)
- 2024-01-25
- 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, Healthy Volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mabxience Research S.L.
- Sponsor organisation
- Mabxience Research S.L.
- Address
- Calle De Manuel Pombo Angulo 28 Floor 3
- City
- Madrid
- Postcode
- 28050
- Country
- Spain
Scientific contact point
- Organisation
- Mabxience Research S.L.
- Contact name
- Susana Millán
Public contact point
- Organisation
- Mabxience Research S.L.
- Contact name
- Susana Millán
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 132 | 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 | 2024-02-12 | 2025-06-04 | 2024-02-12 | 2024-09-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | Netherlands | Acceptable 2024-01-25
|
2024-01-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-13 | Netherlands | Acceptable 2024-02-27
|
2024-02-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-24 | Netherlands | Acceptable 2024-02-27
|
2024-05-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-14 | Netherlands | Acceptable 2024-02-27
|
2024-11-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-14 | Netherlands | Acceptable 2025-01-20
|
2025-01-21 |