Clinical Trial: Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 a
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 Summary:
Sponsor: LipimetiX Development, LLC
Current Primary Outcome:
- Number of Participants Who Incurred at Least One Treatment Emergent Event [ Time Frame: Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57 ]
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
- Number of Participants Who Incurred Mild Treatment Emergent Adverse Events [ Time Frame: Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57 ]
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using d
Original Primary Outcome: 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 ]
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.
Current Secondary Outcome: Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change [ Time Frame: Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57 ]
Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.
Original Secondary Outcome:
Information By: LipimetiX Development, LLC
Dates:
Date Received: March 27, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 23, 2015
Last Verified: March 2015