Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.