Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Treatment of vascular hyperpermeability in patients with sepsis and septic shock.
Key facts
- Sponsor
- Aurobac Therapeutics S.A.S.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 16 Jul 2025 → 24 Oct 2025
- Decision date (initial)
- 2025-07-07
- 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
Treatment of vascular hyperpermeability in patients with sepsis and septic shock.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aurobac Therapeutics S.A.S.
- Sponsor organisation
- Aurobac Therapeutics S.A.S.
- Address
- 29 Avenue Tony Garnier
- City
- Lyon
- Postcode
- 69007
- Country
- France
Scientific contact point
- Organisation
- Aurobac Therapeutics S.A.S.
- Contact name
- Clinical Department
Public contact point
- Organisation
- Aurobac Therapeutics S.A.S.
- Contact name
- Clinical Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Portugal | 2025-07-16 | 2025-10-24 | 2025-07-19 | 2025-10-06 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-12 | Portugal | Acceptable 2025-07-07
|
2025-07-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-03 | Portugal | Acceptable 2025-10-09
|
2025-10-10 |