Study of AT-02 for Systemic Amyloidosis
This study is testing a new medicine called AT-02, given through an IV, for people with systemic amyloidosis (a rare disease where abnormal proteins build up in organs). It's also being tested in healthy volunteers. The main goal is to see how safe AT-02 is and what side effects it might cause. Researchers will also look at how the body handles AT-02. This is an early-stage study, and they plan to enroll about 100 people. There is also a placebo (normal saline solution) given through an IV in one part of the study. This study is trying to find better ways to treat systemic amyloidosis.
- Study design
- This is a Phase 1 interventional study with an unclear status, designed to evaluate AT-02 in healthy volunteers and people with systemic amyloidosis. It includes both blinded and open-label parts, with a planned enrollment of 100 participants.
- What's involved
- Participants will receive AT-02 or a placebo via IV infusion. The study will measure side effects and laboratory values for up to 85 days after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for treatment-emergent adverse events for up to 57 days and for dose-limiting toxicities and laboratory values for up to 85 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis
At a glance
Conditions
Where it's being run
11 sites across 10 statesWho to contact
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What this trial measures
- Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).Up to 57+/-7 days
Safety will be assessed by review of clinical laboratory parameters and incidence and severity of TEAEs (graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5).
- Incidence of dose-limiting toxicities (DLTs) in subjects with systemic amyloidosis.Up to 85+/-7 Days
A DLT is defined as any related TEAE with a National Cancer Institute (NCI) CTCAE version 5.0 Grade ≥3 which also represents a shift from Baseline clinical status of \>1 NCI CTCAE Grade.
- Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.Up to 85+/-7 Days
- Incidence of treatment-emergent anti-drug antibodies (ADA)Up to 85+/-7 Days
The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.