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Radiopharmaceutical

A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 4, and 6.
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a special tagged protein to help doctors see abnormal protein deposits in patients with systemic amyloidosis through imaging scans.

Eligible Conditions
  • Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 4, and 6.
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 4, and 6. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3 spots leftby Dec 2025
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