A Phase 2 interventional study of CSL112 (reconstituted high density lipoprotein) and Placebo in Stable Atherothrombotic Disease, sponsored by CSL Limited. Completed at 11 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-02-06.
Sponsored by CSL Limited · Phase 2, Interventional, and Prevention
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
CSL Limited is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: CSL112 (reconstituted high density lipoprotein)
Biological: Placebo
Single escalating intravenous doses of CSL112
Single intravenous doses of normal saline (0.9%)
Safety
The frequency of study product-related adverse events
Time frame: 14 days
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Number of subjects with clinically significant elevation of ALT or AST
Time frame: 14 days
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
Plasma apoA-I concentration with and without baseline correction
Time frame: 9 days
Plasma apoA-I area under the curve (AUC)
Time frame: 9 days
Plasma apoA-I Cmax
Time frame: 9 days
Plasma apoA-I Tmax
Time frame: 9 days
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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CSL Limited