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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