Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
2
Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
Key facts
- Sponsor
- Antaros Medical AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2026-03-11
- 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
Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10042954 | Systemic sclerosis pulmonary | 100000004855 |
| 21.0 | LLT | 10025109 | Lung involvement in systemic sclerosis | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antaros Medical AB
- Sponsor organisation
- Antaros Medical AB
- Address
- Forandringens Gata 10
- City
- Molndal
- Postcode
- 431 53
- Country
- Sweden
Scientific contact point
- Organisation
- Antaros Medical AB
- Contact name
- Lars Johansson
Public contact point
- Organisation
- Antaros Medical AB
- Contact name
- Lars Johansson
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 15 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-13 | Sweden | Acceptable 2026-03-10
|
2026-03-11 |