NCT05201911

A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis

A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select Organs in Patients With Systemic Amyloidosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Attralus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.

Detailed description

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.

Conditions

• Amyloidosis; Systemic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-09-06
• Completion: 2022-09-06
• First posted: 2022-01-21
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study