A Phase 1 interventional study of ACP-501 in Coronary Artery Disease and Atherosclerosis, sponsored by MedImmune LLC. Completed at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 16 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Currently non-smoking males and females ages 30 to 85 years inclusive.
o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.
Exclusion Criteria:
Drug: ACP-501
A single dose infusion
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
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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MedImmune LLC