Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
14
Countries
1
Sites
1
Urinary Tract Infection
Key facts
- Sponsor
- Schaper & Bruemmer GmbH & Co. KG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 4 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-14
- 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
Urinary Tract Infection
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Schaper & Bruemmer GmbH & Co. KG
- Sponsor organisation
- Schaper & Bruemmer GmbH & Co. KG
- Address
- Bahnhofstrasse 35, Ringelheim Ringelheim
- City
- Salzgitter
- Postcode
- 38259
- Country
- Germany
Scientific contact point
- Organisation
- Schaper & Bruemmer GmbH & Co. KG
- Contact name
- Dr. Jennifer-Christin Kuchernig
Public contact point
- Organisation
- Schaper & Bruemmer GmbH & Co. KG
- Contact name
- Dr. Jennifer-Christin Kuchernig
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 14 | 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 |
|---|---|---|---|---|---|
| Germany | 2025-08-04 | 2025-08-26 | 2025-08-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-13 | Germany | Acceptable 2025-07-11
|
2025-07-14 |