Clinical trial • Phase I • Infectious Disease
BAL2420 for Gram-negative bacterial infection
Phase I trial of BAL2420 for Gram-negative bacterial infection. None/Not specified-controlled. 136 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Gram-negative bacterial infection
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-12-2025
- First CTIS Authorization Date
- 06-02-2026
Trial design
None/Not specified-controlled Phase I trial in Netherlands.
- Comparator
- None/Not specified
- Target Sample Size
- 136
Eligibility
Recruits 136 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in record.
Recruitment
- Planned Sample Size
- 136
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 136
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 3
- Number Of Sites
- 1
- Number Of Participants
- 136
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Renger Tiessen
- Contact Person Email
- Renger.Tiessen@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Basilea Pharmaceutica International AG Allschwil
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- BAL2420
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