Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
56
Countries
1
Sites
1
serious infections caused by selected aerobic gram-negative pathogens in patients with limited treatment options
Key facts
- Sponsor
- Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 30 Jun 2025 → 20 Jul 2025
- Decision date (initial)
- 2025-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
serious infections caused by selected aerobic gram-negative pathogens in patients with limited treatment options
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10038738 | Respiratory thoracic and mediastinal disorders | 13 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Sponsor organisation
- Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Address
- Ul. Aleksandra Fleminga 2
- City
- Warsaw
- Postcode
- 03-176
- Country
- Poland
Scientific contact point
- Organisation
- Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Contact name
- Ilona Łojszczyk, PhD Eng.
Public contact point
- Organisation
- Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Contact name
- Ilona Łojszczyk, PhD Eng.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 56 | 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 |
|---|---|---|---|---|---|
| Czechia | 2025-06-30 | 2025-07-20 | 2025-06-30 | 2025-07-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Czechia | Acceptable 2025-04-23
|
2025-04-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-15 | Czechia | Acceptable 2025-05-30
|
2025-05-30 |