At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
124I-AT-01drug
Likely dose
124I-AT-01 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 124I-AT-01 for Amyloidosis. Completed, enrolled 33 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyloidosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartNov 2021
First PostedFeb 2022
Primary CompletionFeb 2023
Study CompletionFeb 2023
TodayJul 2026
First PostedFeb 11, 2022
Enrollment StartNov 30, 2021
Primary CompletionFeb 6, 2023
Study CompletionFeb 24, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.4 years ago
Interventions
124I-AT-01drug
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.