Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Prevention of infections caused by Gram-negative bacteria
Key facts
- Sponsor
- Remab Therapeutics S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 20 May 2025 → ongoing
- Decision date (initial)
- 2023-06-12
- 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
Prevention of infections caused by Gram-negative bacteria
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Remab Therapeutics S.L.
- Sponsor organisation
- Remab Therapeutics S.L.
- Address
- Calle De Can Domenec S/n
- City
- Cerdanyola Del Valles
- Postcode
- 08193
- Country
- Spain
Scientific contact point
- Organisation
- Remab Therapeutics S.L.
- Contact name
- Rafael Mañez Mendiluce
Public contact point
- Organisation
- Remab Therapeutics S.L.
- Contact name
- Rafael Mañez Mendiluce
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 40 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-05-20 | 2025-05-20 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-31 | Spain | Acceptable 2023-06-12
|
2023-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-27 | Spain | Acceptable 2024-02-26
|
2024-02-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | Spain | Acceptable 2024-10-03
|
2024-10-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | Spain | Acceptable 2025-04-24
|
2025-04-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-29 | Spain | Acceptable 2025-09-01
|
2025-09-05 |