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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL112 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL112 (reconstituted high density lipoprotein) | Biological | Single escalating intravenous doses of CSL112 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The frequency of study product-related adverse events | 14 days |
| Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) | Number of subjects with clinically significant elevation of ALT or AST | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of apolipoprotein A-I (apoA-I) | Plasma apoA-I concentration with and without baseline correction | 9 days |
| Plasma apoA-I area under the curve (AUC) | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Denise D'Andrea | CSL Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Chula Vista | California | 91911 | United States | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33217027 | Derived | Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23. | |
| 26307570 |
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| Placebo | Biological | Single intravenous doses of normal saline (0.9%) |
|
| Plasma apoA-I Cmax | 9 days |
| Plasma apoA-I Tmax | 9 days |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Study Site | Miami | Florida | 33126 | United States |
| Study Site | Lexington | Kentucky | 40536 | United States |
| Study Site | Madisonville | Kentucky | 42431 | United States |
| Study Site | Auburn | Maine | 04210 | United States |
| Study Site | Baltimore | Maryland | 21215 | United States |
| Study Site | Petoskey | Michigan | 49770 | United States |
| Study Site | Durham | North Carolina | 27710 | United States |
| Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Study Site | Rapid City | South Dakota | 57701 | United States |
| 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. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial. J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171. |
| ID | Term |
|---|---|
| C584257 | CSL112 |
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