Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Idiopahtic pulmonary fibrosis
Key facts
- Sponsor
- Vicore Pharma AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 14 May 2025 → 25 Aug 2025
- Decision date (initial)
- 2025-04-22
- 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
Idiopahtic pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vicore Pharma AB
- Sponsor organisation
- Vicore Pharma AB
- Address
- Kornhamnstorg 53
- City
- Stockholm
- Postcode
- 111 27
- Country
- Sweden
Scientific contact point
- Organisation
- Vicore Pharma AB
- Contact name
- Global Medical Manager
Public contact point
- Organisation
- Vicore Pharma AB
- Contact name
- Global Medical Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 30 | 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 | 2025-05-14 | 2025-08-25 | 2025-05-14 | 2025-05-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-18 | Sweden | Acceptable 2025-04-22
|
2025-04-22 |