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Radiopharmaceutical
Injection of I-124 AT03. for Amyloidosis (AT03-001 Trial)
Phase 1
Waitlist Available
Research Sponsored by Attralus, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Understands the study procedures and capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
a histologic confirmation with a biopsy containing deposits of apple-green birefringent, congophilic material;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 4, and 6.
Awards & highlights
AT03-001 Trial Summary
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
Eligible Conditions
- Amyloidosis
AT03-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAT03-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 4, and 6.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 4, and 6.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Number of participants with abnormal laboratory test results.
Number of participants with treatment-related adverse events.
Selected tissue-bound half-life of 124I-AT-03 in subjects with systemic amyloidosis.
+1 moreAT03-001 Trial Design
1Treatment groups
Experimental Treatment
Group I: Injection of I-124 AT03.Experimental Treatment1 Intervention
Single arm only, no placebo or comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
124I-AT03
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Attralus, Inc.Lead Sponsor
6 Previous Clinical Trials
337 Total Patients Enrolled
6 Trials studying Amyloidosis
337 Patients Enrolled for Amyloidosis
Gregory Bell, MDStudy DirectorAttralus, Inc.
6 Previous Clinical Trials
1,363 Total Patients Enrolled
Frequently Asked Questions
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