Clinical trial • Phase III • Other
68Ga-ATH001 (Gallium-68 labeled PDGFRβ targeting tracer) for Systemic sclerosis-associated interstitial lung disease
Phase III trial of 68Ga-ATH001 (Gallium-68 labeled PDGFRβ targeting tracer) for Systemic sclerosis-associated interstitial lung disease. 15 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Systemic sclerosis-associated interstitial lung disease
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 02-02-2026
- First CTIS Authorization Date
- 11-03-2026
Trial design
Phase III trial across 2 sites in Sweden.
- Target Sample Size
- 15
Recruitment
- Planned Sample Size
- 15
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 15
Sweden
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 37
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC
- Contact Person Name
- Erik Rein-Hedin
- Contact Person Email
- erik.rein-hedin@ctc-ab.se
- Site Name
- Uppsala University Hospital
- Department Name
- Section of rheumatology
- Contact Person Name
- Karin Hjorton
- Contact Person Email
- karin.hjorton@akademiska.se
Sponsor
Primary sponsor
- Full Name
- Antaros Medical AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Gallium-68 (68Ga) labeled Platelet-Derived Growth Factor Beta (PDGFRß) targeting PET tracer (68Ga-ATH001)
- Active Substance
- 68Ga-ATH001 (Gallium-68 labeled PDGFRβ targeting tracer)
- Modality
- Radiopharmaceutical
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