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The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal saline (0.9%) | Placebo Comparator |
| |
| CSL112 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL112 (reconstituted HDL) | Biological | Single escalating intravenous doses of CSL112 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by the frequency of drug-related clinical adverse events. | Up to 14 days after infusion of CSL112 | |
| Safety and tolerability as measured by liver function tests. | Up to 14 days after infusion of CSL112 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of lipoprotein. | Plasma levels of lipoprotein. | Up to 10 days after infusion of CSL112 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | 5000 | 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. |
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| ID | Term |
|---|---|
| C584257 | CSL112 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline (0.9%) |
| Biological |
Single intravenous dose of normal saline (0.9%) |
|