NCT05235269

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

A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Attralus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-02-06
• Completion: 2023-02-24
• First posted: 2022-02-11
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study