Clinical trial • Phase I • Other
BI 3804379 for Metabolic dysfunction-associated steatohepatitis
Phase I trial of BI 3804379 for Metabolic dysfunction-associated steatohepatitis. 124 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Metabolic dysfunction-associated steatohepatitis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 27-06-2024
- First CTIS Authorization Date
- 02-09-2024
Trial design
Phase I trial across 1 site in Belgium.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 124
Eligibility
Recruits 124 Vulnerable populations not selected; no consent/assent handling described..
- Vulnerable Population
- Vulnerable populations not selected; no consent/assent handling described.
Recruitment
- Planned Sample Size
- 124
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent process not described in the CTIS record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 124
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 637
- Number Of Sites
- 1
- Number Of Participants
- 124
Sites
- Site Name
- SGS Belgium
- Department Name
- Clinical Research Clinical Pharmacology Unit
- Contact Person Name
- Thomas De Ridder
- Contact Person Email
- Thomas.DeRidder@sgs.com
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Industry
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 3804379
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