| Primary | Percent of Participants With Clinically Important Change in Drug-induced Liver Injury | A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement. | The Safety population (SP) comprised all subjects who were randomized into the main study or PK/PD substudy and received at least a partial infusion of the investigational product. | Posted | | Number | | percentage of participants | | From baseline (before first infusion) to Day 29. | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Newcombe-Wilson score method | | = 0.1241 | | Difference in event rates (%) | 1.0 | | | 2-Sided | 95 | -0.1 | 2.5 | | | | | Non-Inferiority | The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control. | |
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| Primary | Percent of Participants With Clinically Important Change in Renal Status | A clinically important change in renal status is defined as a serum creatinine (Cr) increase to ≥ 1.5 x the baseline value that is confirmed upon repeat measurement. | | Posted | | Number | | percentage of participants | | From baseline (before first infusion) to Day 29. | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
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| Secondary | The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE) | The MACE is a 4-component composite comprised of the time to the first of the following events: CV death, nonfatal myocardial infarction, ischemic stroke (non-hemorrhagic), and hospitalization for unstable angina. | The Intent-to-Treat (ITT) population comprised all subjects who were randomized to one of the three treatment groups for the Main Study or PK/PD substudy. | Posted | | Number | | percentage of participants | | From the start of the first infusion up to approximately 382 days | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
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| Secondary | Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants | Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112 | The pharmacokinetic population (PK) comprised all subjects who received at least 1 infusion of investigational product and had at least 1 post baseline measurable plasma concentration of apoA-I or PC. | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants | | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function | apoA-I and PC are analytes of CSL112 | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function | apoA-I and PC are analytes of CSL112 | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment | apoA-I and PC are analytes of CSL112 | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment | apoA-I and PC are analytes of CSL112 | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion and end of fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants | Cmax is the maximal plasma concentration. | The Pharmacokinetic/Pharmacodynamic (PK/PD) population was a subset of subjects from the main study who consented to participate in the PK/PD substudy. | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants | Cmax is the maximal plasma concentration. | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function | Cmax is the maximal plasma concentration. | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | Cmax is the maximal plasma concentration. | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | Cmax is the maximal plasma concentration. | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | Cmax is the maximal plasma concentration. | | Posted | | Mean | Standard Deviation | mg/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | Tmax is time to maximal plasma concentration | | Posted | | Median | Full Range | hours | | Before and for 7 days after the fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last] | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | AUC from baseline to time point t (AUC0-t) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | AUC0-∞ is plasma area under the curve (AUC0-infinity) | | Posted | | Mean | Standard Deviation | mg•h/dL | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | hours | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
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| Secondary | Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | L/h | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
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| Secondary | Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after first infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment | | | Posted | | Mean | Standard Deviation | Liters | | Before first infusion (baseline) and for up to approximately 7 days after fourth infusion | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions | The overall percentage of subjects:
- with adverse events (AEs), including local tolerability events, that begin during or within 1 hour of an infusion; or
- with AEs considered to be causally related to the test product; or
- who experience an AE for which the incidence rate in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.
| | Posted | | Number | | percentage of participants | | From the start of first infusion, up to approximately Day 382 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | |
|
| Secondary | Percent of Participants With Any Adverse Event (AE) | | | Posted | | Number | | percentage of participants | | From the start of first infusion, up to approximately Day 382 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Percent of Participants Who Experience Bleeding Events | The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011) | | Posted | | Number | | percentage of participants | | From the start of first infusion, up to approximately Day 112 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
|
| Secondary | Change From Baseline in Serum Antibodies to CSL112 and apoA-I | | | Posted | | Mean | Standard Deviation | Titer | | Before first infusion, up to approximately Day 112 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19 | | Serology population are a random subset of participants that was selected and had their samples tested for the presence of parvovirus B19. | Posted | | Number | | participants | | Study Day 112 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |
| Secondary | Number of Participants With Parvovirus B19 DNA in Serum | | | Posted | | Number | | participants | | Study Day 112 | | | | ID | Title | Description |
|---|
| OG000 | CSL112 (2 g) | CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG001 | CSL112 (6 g) | CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks. CSL112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles. | | OG002 | Placebo | Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion. Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline) |
| |