Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
1
Healthy volunteer trial. Intended indication: treatment of infections due to A. baumannii.
Key facts
- Sponsor
- Bioversys S.A.S.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 12 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-01
- 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
Healthy volunteer trial. Intended indication: treatment of infections due to A. baumannii.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioversys S.A.S.
- Sponsor organisation
- Bioversys S.A.S.
- Address
- 1 Rue Du Professeur Calmette
- City
- Lille
- Postcode
- 59800
- Country
- France
Scientific contact point
- Organisation
- Bioversys S.A.S.
- Contact name
- Chief Development Officer
Public contact point
- Organisation
- Bioversys S.A.S.
- Contact name
- Chief Development Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 16 | 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 |
|---|---|---|---|---|---|
| Austria | 2026-03-12 | 2026-03-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-28 | Austria | Acceptable 2026-02-23
|
2026-03-01 |