Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
32
Countries
1
Sites
1
Immune system Diseases
Key facts
- Sponsor
- Oxion Biologics AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Apr 2025 → 30 Oct 2025
- Decision date (initial)
- 2025-03-19
- 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
Immune system Diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10003816 | Autoimmune disorders | 10021428 |
| 27.0 | PT | 10061218 | Inflammation | 100000004867 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oxion Biologics AB
- Sponsor organisation
- Oxion Biologics AB
- Address
- Box 5376
- City
- Stockholm
- Postcode
- 102 49
- Country
- Sweden
Scientific contact point
- Organisation
- Oxion Biologics AB
- Contact name
- CSO Felix Sellberg
Public contact point
- Organisation
- Oxion Biologics AB
- Contact name
- CSO Felix Sellberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 32 | 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 |
|---|---|---|---|---|---|
| Sweden | 2025-04-03 | 2025-10-30 | 2025-04-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-13 | Sweden | Acceptable 2025-03-18
|
2025-03-19 |