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A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis

NCT05235269 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-09-04

Study results available
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Summary

This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.

Conditions

  • Amyloidosis

Interventions

DRUG

124I-AT-01

All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.

Sponsors & Collaborators

  • Attralus, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory M. Bell, MD · Attralus, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-02-06
Completion
2023-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235269 on ClinicalTrials.gov