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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL112 | Experimental | Multiple ascending intravenous doses of CSL112 |
|
| Placebo | Placebo Comparator | Multiple intravenous infusions of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL112 | Biological | reconstituted high density lipoprotein |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of drug-related adverse events | Up to 6 days after each infusion | |
| The frequency of redness and swelling at the infusion site | up to 24 hours after each infusion | |
| Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) | up to 6 days after each infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of apoA-I after multiple intravenous infusions | up to 7 days after each infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Director, Cardiovascular | CSL Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm | Brisbane | Queensland | 4006 | Australia |
| 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. | |
| 24122814 |
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| ID | Term |
|---|---|
| C584257 | CSL112 |
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| Placebo |
| Biological |
Normal saline (0.9%) |
|
| Easton R, Gille A, D'Andrea D, Davis R, Wright SD, Shear C. A multiple ascending dose study of CSL112, an infused formulation of ApoA-I. J Clin Pharmacol. 2014 Mar;54(3):301-10. doi: 10.1002/jcph.194. Epub 2013 Oct 22. |