Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
46
Countries
1
Sites
1
Urinary tract infections (UTIs)/complicated UTI (cUTI)
Key facts
- Sponsor
- Adjutec Pharma AS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 28 Aug 2024 → 10 Mar 2025
- Decision date (initial)
- 2024-05-06
- 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 infections (UTIs)/complicated UTI (cUTI)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10046577 | Urinary tract infections | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adjutec Pharma AS
- Sponsor organisation
- Adjutec Pharma AS
- Address
- Ullernchausseen 64
- City
- Oslo
- Postcode
- 0379
- Country
- Norway
Scientific contact point
- Organisation
- Adjutec Pharma AS
- Contact name
- Bjørg Bolstad
Public contact point
- Organisation
- Adjutec Pharma AS
- Contact name
- Bjørn Klem
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 46 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-08-28 | 2025-03-10 | 2024-09-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | Sweden | Acceptable 2024-05-06
|
2024-05-06 |