NCT02100839

Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: LipimetiX Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Interventions

Type	Name	Description
DRUG	AEM-28	Solution for injection
DRUG	Normal Saline	0.9% saline for injection

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-04-01
• Last updated: 2015-12-29
• Results posted: 2015-12-29

Locations

1 site across 1 country: Australia