Clinical trial • Phase I • Other
DOTA-Cys-ATH001 labelled with gallium-68 ([68Ga]) for Metabolic dysfunction-associated steatohepatitis (MASH) | Crohn's disease | Primary sclerosing cholangitis
Phase I trial of DOTA-Cys-ATH001 labelled with gallium-68 ([68Ga]) for Metabolic dysfunction-associated steatohepatitis (MASH) | Crohn's disease | Primary…
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Metabolic dysfunction-associated steatohepatitis (MASH) | Crohn's disease | Primary sclerosing cholangitis
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 15-02-2024
- First CTIS Authorization Date
- 07-05-2024
Trial design
Phase I trial across 3 sites in Sweden.
- Target Sample Size
- 30
Eligibility
Recruits 30 No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent handling not specified in the record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent handling not specified in the record.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 30
Sweden
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 647
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Section of Gastroenterology/Hepatology
- Principal Investigator Name
- Johan Vessby
- Principal Investigator Email
- johan.vessby@akademiska.se
- Contact Person Name
- Johan Vessby
- Contact Person Email
- johan.vessby@akademiska.se
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC
- Principal Investigator Name
- Sonia Jonsson
- Principal Investigator Email
- sonia.jonsson@ctc-ab.se
- Contact Person Name
- Sonia Jonsson
- Contact Person Email
- sonia.jonsson@ctc-ab.se
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC
- Principal Investigator Name
- Erik Rein-Hedin
- Principal Investigator Email
- erik.rein-hedin@ctc-ab.se
- Contact Person Name
- Erik Rein-Hedin
- Contact Person Email
- erik.rein-hedin@ctc-ab.se
Sponsor
Primary sponsor
- Full Name
- Antaros Medical AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- [68Ga]Ga-DOTA-Cys-ATH001
- Active Substance
- DOTA-Cys-ATH001 labelled with gallium-68 ([68Ga])
- Modality
- Radiopharmaceutical
- First In Human
- Yes
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