This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.
After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
A single dose infusion
Cardiovascular and Pulmonary Branch (CPB) of NIH
Bethesda, Maryland, United States
Summary of Participants Experience with Safety and Tolerability
Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).
Time frame: Day 1 to Day 28
Pharmacokinetic profile
Time frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168
Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose
Time frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168
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