This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
Eligible subjects will receive a single dose of radiolabeled AT-03, a fusion protein of serum amyloid P and a single chain Fc receptor. Repeat Positron Emission Tomography/Computed Tomography (PET/CT) scans will be performed over a \~7 day period to assess the biodistribution of AT-03 to amyloid-containing tissues in patients with systemic amyloidosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
13
IV injection of the radiolabeled compound on day 1 followed by Positron Emission Tomography/Computed Tomography (PET/CT) scanning on Days 2, 4 and 8 to. The first 3 subjects enrolled will have two additional scans on Day 1.
University of Tennessee Medical Center
Knoxville, Tennessee, United States
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
Time frame: Day 4.
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
Time frame: Day 6.
Number of participants with treatment-related adverse events.
Incidence of treatment-emergent adverse events from Day 1 to Day 28.
Time frame: Assessed from time of consent through the day 28 follow-up phone call.
Number of participants with abnormal laboratory test results.
Change from Baseline in clinical laboratory values at Days 4 and 6.
Time frame: Assessed from time of consent through Day 6.
Whole blood radioactivity of 124I-AT-03 in subjects with systemic amyloidosis.
Whole body radiation dose by dosimetry in all enrolled subjects. Whole blood radioactivity (corrected for radioactive decay).
Time frame: Days 1, 4, and 6.
Selected tissue-bound half-life of 124I-AT-03 in subjects with systemic amyloidosis.
Organ specific radioactivity for the heart, kidneys, liver, and spleen at Days 4 and 6.
Time frame: Days 4 and 6.
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