At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AEM-28 in Healthy Subjects and Patients With Refractory Hypercholesterolemia
In Brief
A Phase 2 clinical trial evaluating AEM-28 and Normal Saline for Hypercholesterolemia and Hyperlipoproteinemia Type II. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia. AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.
Study Details
Timeline
Interventions
Solution for injection
0.9% saline for injection