Clinical trial • Phase I • Other
BI 3821001 for Healthy volunteers
Phase I trial of BI 3821001 for Healthy volunteers. None/Not specified-controlled. 72 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 23-01-2026
- First CTIS Authorization Date
- 18-03-2026
Trial design
None/Not specified-controlled Phase I trial across 1 site in Germany.
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 72
Eligibility
Recruits 72 Vulnerable population not selected; study population: healthy male volunteers. No specific information on consent or assent handling is provided in the record..
- Vulnerable Population
- Vulnerable population not selected; study population: healthy male volunteers. No specific information on consent or assent handling is provided in the record.
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 5
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 72
Germany
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 72
Sites
- Site Name
- CRS Clinical Research Services Berlin GmbH
- Department Name
- Clinical Pharmacology Unit
- Contact Person Name
- Matthias Berse
- Contact Person Email
- matthias.berse@crs-group.de
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 3821001
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