Clinical trial • Phase I • Gastroenterology
AGMB-101 for Liver cirrhosis
Phase I trial of AGMB-101 for Liver cirrhosis. None/Not specified-controlled, adaptive. 64 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Liver cirrhosis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 27-11-2024
- First CTIS Authorization Date
- 21-02-2025
Trial design
None/Not specified-controlled, adaptive Phase I trial across 1 site in Belgium.
- Comparator
- None/Not specified
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 64
Eligibility
Recruits 64 Vulnerable populations not selected; no special consent/assent handling mentioned..
- Vulnerable Population
- Vulnerable populations not selected; no special consent/assent handling mentioned.
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 64
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-01-2025
- Latest Decision Or Authorization Date
- 27-02-2025
- Processing Time Days
- 51
- Number Of Sites
- 1
- Number Of Participants
- 64
Sites
- Site Name
- SGS Belgium
- Department Name
- SGS-Clinical Research CPU
- Contact Person Name
- Frédéric Vanhoutte
- Contact Person Email
- Frederic.Vanhoutte@sgs.com
Sponsor
Primary sponsor
- Full Name
- AgomAb Therapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- AGMB-101
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