Conditions: Hypercholesterolemia Hyperlipoproteinemia Type II
Keywords: hypercholesterolemia apolipoprotein E First in Human Apolipoprotein E (ApoE) Apolipoprotein E Mimetic (AEM)
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg. arm 2: Single Ascending Dose: Single IV dose for each cohort.

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.

Interventions: intervention 1: AEM-28 intervention 2: Normal Saline
Intervention descriptions: intervention 1: Solution for injection intervention 2: 0.9% saline for injection

Protocol document: