Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
136
Countries
1
Sites
1
Severe infections caused by Gram-negative bacteria
Key facts
- Sponsor
- Basilea Pharmaceutica International AG Allschwil
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 4 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-06
- 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
Severe infections caused by Gram-negative bacteria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10018657 | Gram-negative bacterial infection NOS | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Basilea Pharmaceutica International AG Allschwil
- Sponsor organisation
- Basilea Pharmaceutica International AG Allschwil
- Address
- Hegenheimermattweg 167b
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 136 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-03-04 | 2026-03-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-15 | Netherlands | Acceptable 2026-02-05
|
2026-02-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-16 | Netherlands | Acceptable 2026-02-05
|
2026-03-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-28 | Netherlands | Acceptable | 2026-06-02 |