A Phase 1 interventional study of 124I-AT03 in Amyloidosis; Systemic, sponsored by Attralus, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Attralus, Inc. · Phase 1, Interventional, and Diagnostic
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.
491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 304 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →Attralus, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of systemic amyloidosis based on any one of the following:
For women of childbearing potential: agreement to remain as abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 90 days after the last dose of study intervention.
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
Exclusion Criteria:
Single arm only, no placebo or comparator
Drug: 124I-AT03
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.
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.
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Attralus, Inc.