Clinical trial • Phase I • Endocrinology
AX-0810 for Cholestatic liver disease
Phase I trial of AX-0810 for Cholestatic liver disease. None/Not specified-controlled. 37 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Cholestatic liver disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-06-2025
- First CTIS Authorization Date
- 14-10-2025
Trial design
None/Not specified-controlled Phase I trial across 1 site in Netherlands.
- Comparator
- None/Not specified
- Target Sample Size
- 37
Eligibility
Recruits 37 isVulnerablePopulationSelected=false; No vulnerable populations selected.
- Vulnerable Population
- isVulnerablePopulationSelected=false; No vulnerable populations selected
Recruitment
- Planned Sample Size
- 37
- Recruitment Window Months
- 14
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 37
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 150
- Number Of Sites
- 1
- Number Of Participants
- 37
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Menagement
- Contact Person Name
- Maria Velinova-Donga
- Contact Person Email
- Maria.Velinova@iconplc.com
- Number Of Participants
- 37
Sponsor
Primary sponsor
- Full Name
- ProQR Therapeutics VIII B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Program Management / site contact (as listed in trialSites)
Investigational products
- Investigational Product Name
- AX-0810
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