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A multiple ascending dose study of CSL112, an infused formulation of ApoA-I.

Easton R, Gille A, D'Andrea D, Davis R, Wright SD, Shear C.

J Clin Pharmacol. 2014 Mar;54(3):301-10. doi: 10.1002/jcph.194.


Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial.

Tricoci P, D'Andrea DM, Gurbel PA, Yao Z, Cuchel M, Winston B, Schott R, Weiss R, Blazing MA, Cannon L, Bailey A, Angiolillo DJ, Gille A, Shear CL, Wright SD, Alexander JH.

J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171.


CSL112 enhances biomarkers of reverse cholesterol transport after single and multiple infusions in healthy subjects.

Gille A, Easton R, D'Andrea D, Wright SD, Shear CL.

Arterioscler Thromb Vasc Biol. 2014 Sep;34(9):2106-14. doi: 10.1161/ATVBAHA.114.303720.


Novel formulation of a reconstituted high-density lipoprotein (CSL112) dramatically enhances ABCA1-dependent cholesterol efflux.

Diditchenko S, Gille A, Pragst I, Stadler D, Waelchli M, Hamilton R, Leis A, Wright SD.

Arterioscler Thromb Vasc Biol. 2013 Sep;33(9):2202-11. doi: 10.1161/ATVBAHA.113.301981.


Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction.

Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA.

Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017.


High-Density Lipoprotein Subfractions and Cholesterol Efflux Capacities After Infusion of MDCO-216 (Apolipoprotein A-IMilano/Palmitoyl-Oleoyl-Phosphatidylcholine) in Healthy Volunteers and Stable Coronary Artery Disease Patients.

Kempen HJ, Asztalos BF, Moerland M, Jeyarajah E, Otvos J, Kallend DG, Bellibas SE, Wijngaard PL.

Arterioscler Thromb Vasc Biol. 2016 Apr;36(4):736-42. doi: 10.1161/ATVBAHA.115.307052.


Emerging high-density lipoprotein infusion therapies: fulfilling the promise of epidemiology?

Tardif JC.

J Clin Lipidol. 2010 Sep-Oct;4(5):399-404. doi: 10.1016/j.jacl.2010.08.018.


Enhanced HDL Functionality in Small HDL Species Produced Upon Remodeling of HDL by Reconstituted HDL, CSL112: Effects on Cholesterol Efflux, Anti-Inflammatory and Antioxidative Activity.

Didichenko SA, Navdaev AV, Cukier AM, Gille A, Schuetz P, Spycher MO, Thérond P, Chapman MJ, Kontush A, Wright SD.

Circ Res. 2016 Sep 2;119(6):751-63. doi: 10.1161/CIRCRESAHA.116.308685.


Pharmacokinetics of reconstituted human high-density lipoprotein in pigs after hemorrhagic shock with resuscitation.

DiPiro JT, Cue JI, Richards CS, Hawkins ML, Doran JE, Mansberger AR.

Crit Care Med. 1996 Mar;24(3):440-4.


Intravenous apoA-I/lecithin discs increase pre-beta-HDL concentration in tissue fluid and stimulate reverse cholesterol transport in humans.

Nanjee MN, Cooke CJ, Garvin R, Semeria F, Lewis G, Olszewski WL, Miller NE.

J Lipid Res. 2001 Oct;42(10):1586-93.


Pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of ticagrelor in healthy volunteers.

Butler K, Teng R.

Br J Clin Pharmacol. 2010 Jul;70(1):65-77. doi: 10.1111/j.1365-2125.2010.03669.x.


Metabolism of high density lipoprotein subfractions and constituents in Tangier disease following the infusion of high density lipoproteins.

Schaefer EJ, Anderson DW, Zech LA, Lindgren FT, Bronzert TB, Rubalcaba EA, Brewer HB Jr.

J Lipid Res. 1981 Feb;22(2):217-28.


Formation of high density lipoproteins containing both apolipoprotein A-I and A-II in the rabbit.

Hime NJ, Drew KJ, Wee K, Barter PJ, Rye KA.

J Lipid Res. 2006 Jan;47(1):115-22.


Pegylation of high-density lipoprotein decreases plasma clearance and enhances antiatherogenic activity.

Murphy AJ, Funt S, Gorman D, Tall AR, Wang N.

Circ Res. 2013 Jun 21;113(1):e1-9. doi: 10.1161/CIRCRESAHA.113.301112.


Safety, tolerability and pharmacokinetics of dalcetrapib following single and multiple ascending doses in healthy subjects: a randomized, double-blind, placebo-controlled, phase I study.

Derks M, Anzures-Cabrera J, Turnbull L, Phelan M.

Clin Drug Investig. 2011;31(5):325-35. doi: 10.2165/11533550-000000000-00000.


Restoration of endothelial function by increasing high-density lipoprotein in subjects with isolated low high-density lipoprotein.

Bisoendial RJ, Hovingh GK, Levels JH, Lerch PG, Andresen I, Hayden MR, Kastelein JJ, Stroes ES.

Circulation. 2003 Jun 17;107(23):2944-8.


High-density lipoprotein/apolipoprotein A-I infusion therapy.

Tardif JC, Heinonen T, Noble S.

Curr Atheroscler Rep. 2009 Jan;11(1):58-63. Review.


A single infusion of MDCO-216 (ApoA-1 Milano/POPC) increases ABCA1-mediated cholesterol efflux and pre-beta 1 HDL in healthy volunteers and patients with stable coronary artery disease.

Kallend DG, Reijers JA, Bellibas SE, Bobillier A, Kempen H, Burggraaf J, Moerland M, Wijngaard PL.

Eur Heart J Cardiovasc Pharmacother. 2016 Jan;2(1):23-9. doi: 10.1093/ehjcvp/pvv041.


Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque.

Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM.

Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063.

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