Clinical trial • Phase III • Other
BI 3031185 for Healthy volunteer
Phase III trial of BI 3031185 for Healthy volunteer. 60 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 02-12-2024
- First CTIS Authorization Date
- 30-01-2025
Trial design
Phase III trial across 1 site in Germany.
- Target Sample Size
- 60
- Trial Duration For Participant
- 574
Eligibility
Recruits 60 Vulnerable population not selected; no consent or assent details provided..
- Vulnerable Population
- Vulnerable population not selected; no consent or assent details provided.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 18
- Consent Approach
- Not provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Germany
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 479
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Charite Research Organisation GmbH
- Department Name
- Charité - Universitätsmedizin Berlin
- Contact Person Name
- Christian Keicher
- Contact Person Email
- christian.keicher@charite-research.org
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 3031185
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