Hypercholesterolemia Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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