{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["4(8)"],"submitter":["Tricoci P"],"pubmed_abstract":["<h4>Background</h4>CSL112 is a new formulation of human apolipoprotein A-I (apoA-I) being developed to reduce cardiovascular events following acute coronary syndrome. This phase 2a, randomized, double-blind, multicenter, dose-ranging trial represents the first clinical investigation to assess the safety and pharmacokinetics/pharmacodynamics of a CSL112 infusion among patients with stable atherosclerotic disease.<h4>Methods and results</h4>Patients were randomized to single ascending doses of CSL112 (1.7, 3.4, or 6.8 g) or placebo, administered over a 2-hour period. Primary safety assessments consisted of alanine aminotransferase or aspartate aminotransferase elevations >3× upper limits of normal and study drug-related adverse events. Pharmacokinetic/pharmacodynamic assessments included apo"],"journal":["Journal of the American Heart Association"],"pagination":["e002171"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4599471"],"repository":["biostudies-literature"],"pubmed_title":["Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial."],"pmcid":["PMC4599471"],"pubmed_authors":["Winston B","Shear CL","Gurbel PA","D'Andrea DM","Cuchel M","Cannon L","Wright SD","Tricoci P","Bailey A","Gille A","Yao Z","Angiolillo DJ","Alexander JH","Blazing MA","Weiss R","Schott R"],"additional_accession":[]},"is_claimable":false,"name":"Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial.","description":"<h4>Background</h4>CSL112 is a new formulation of human apolipoprotein A-I (apoA-I) being developed to reduce cardiovascular events following acute coronary syndrome. This phase 2a, randomized, double-blind, multicenter, dose-ranging trial represents the first clinical investigation to assess the safety and pharmacokinetics/pharmacodynamics of a CSL112 infusion among patients with stable atherosclerotic disease.<h4>Methods and results</h4>Patients were randomized to single ascending doses of CSL112 (1.7, 3.4, or 6.8 g) or placebo, administered over a 2-hour period. Primary safety assessments consisted of alanine aminotransferase or aspartate aminotransferase elevations >3× upper limits of normal and study drug-related adverse events. Pharmacokinetic/pharmacodynamic assessments included apo","dates":{"release":"2015-01-01T00:00:00Z","publication":"2015 Aug","modification":"2026-05-05T02:44:07.629Z","creation":"2019-03-27T01:59:48Z"},"accession":"S-EPMC4599471","cross_references":{"pubmed":["26307570"],"doi":["10.1161/JAHA.115.002171"]}}