Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
7
Countries
1
Sites
1
Acute Respiratory Distress Syndrome - ARDS
Key facts
- Sponsor
- Region Uppsala
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- completed 15 Apr 2026
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518160-13-00
- EudraCT number
- 2019-004462-18
- ClinicalTrials.gov
- NCT04447833
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Respiratory Distress Syndrome - ARDS
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Uppsala
- Sponsor organisation
- Region Uppsala
- Address
- Storgatan 27, Uppsala Domkyrkofors. Uppsala Domkyrkofors.
- City
- Uppsala
- Postcode
- 753 31
- Country
- Sweden
Scientific contact point
- Organisation
- Region Uppsala
- Contact name
- Oscar Simonsson
Public contact point
- Organisation
- Region Uppsala
- Contact name
- Oscar Simonsson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 7 | 1 |
| 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 | 2024-10-16 | Sweden | Acceptable 2024-10-25
|
2024-10-25 |