Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
160
Countries
1
Sites
1
Chronic inflammatory diseases
Key facts
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Nov 2025 → 19 May 2026
- Decision date (initial)
- 2025-11-03
- 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
Chronic inflammatory diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10037153 | Psoriasis | 100000004858 |
| 21.1 | PT | 10037162 | Psoriatic arthropathy | 100000004859 |
| 28.0 | PT | 10011401 | Crohn´s disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fresenius Kabi SwissBioSim GmbH
- Sponsor organisation
- Fresenius Kabi SwissBioSim GmbH
- Address
- Route De Crassier 23
- City
- Eysins
- Postcode
- 1262
- Country
- Switzerland
Scientific contact point
- Organisation
- Fresenius Kabi SwissBioSim GmbH
- Contact name
- Andras Illes
Public contact point
- Organisation
- Fresenius Kabi SwissBioSim GmbH
- Contact name
- Leszek Michal Bialecki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 160 | 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 |
|---|---|---|---|---|---|
| Poland | 2025-11-15 | 2026-05-18 | 2025-11-15 | 2026-01-24 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-15 | Poland | Acceptable 2025-10-30
|
2025-11-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-27 | Poland | Acceptable 2025-10-30
|
2026-02-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-27 | Poland | Acceptable 2025-10-30
|
2026-05-27 |