Safety Study of AEM-28 to Treat 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.
Hyperlipoproteinemia Type II
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Safety and Tolerability [ Time Frame: From 1st dose, Day 1, to Day 8 for SAD study; From 1st dose, Day 1, to Day 57 for MAD study ] [ Designated as safety issue: Yes ]Assessment of adverse events (i.e. seriousness, severity, relationship to AEM-28), vital signs, ECG, clinical laboratory parameters, physical examinations, local response to each injection and body weight.
|Study Start Date:||March 2014|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
Solution for injection
Other Name: apolipoprotein E mimetic
Placebo Comparator: Normal Saline
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.
Drug: Normal Saline
0.9% saline for injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT02100839
|Australia, Western Australia|
|Linear Clinical Research Ltd.|
|Nedlands, Western Australia, Australia, 6009|
|Principal Investigator:||Janakan Krishnarajah, MBBS, FRACP||Linear Clinical Research Ltd.|