Clinical trial • Phase I | Phase III • Gastroenterology
FAPI-46 (labelled with Gallium-68) for Advanced liver fibrosis | Hepatic fibrosis
Phase I | Phase III trial of FAPI-46 (labelled with Gallium-68) for Advanced liver fibrosis | Hepatic fibrosis. open-label. 12 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Advanced liver fibrosis | Hepatic fibrosis
- Trial Stage
- Phase I | Phase III
- Drug Modality
- Radiopharmaceutical | Small molecule
Key dates
- Initial CTIS Submission Date
- 21-11-2024
- First CTIS Authorization Date
- 12-02-2025
Trial design
open-label Phase I | Phase III trial across 2 sites in Sweden.
- Open Label
- Yes
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable populations not selected; no special consent or assent handling specified in the record..
- Vulnerable Population
- Vulnerable populations not selected; no special consent or assent handling specified in the record.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 12
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 26-03-2025
- Processing Time Days
- 163
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Tema Cancer, Medicinsk Enhet Övre Buk
- Principal Investigator Name
- Hannes Hagström
- Principal Investigator Email
- hannes.hagstrom@ki.se
- Contact Person Name
- Hannes Hagström
- Contact Person Email
- hannes.hagstrom@ki.se
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC
- Principal Investigator Name
- Kaveh Azizi
- Principal Investigator Email
- kaveh.azizi@ctc-ab.se
- Contact Person Name
- Kaveh Azizi
- Contact Person Email
- kaveh.azizi@ctc-ab.se
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- [68Ga]Ga-FAPI-46
- Active Substance
- FAPI-46 (labelled with Gallium-68)
- Modality
- Radiopharmaceutical
- Investigational Product Name
- AZD2389
- Active Substance
- AZD2389
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Frequency
- Single dose
- Combination Treatment
- Yes
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