Trial Outcomes & Findings for A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction. (NCT NCT02108262)

Last Updated: 2021-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1267 participants

Primary outcome timeframe

From baseline (before first infusion) to Day 29.

Results posted on

2021-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Lead-in [CSL112 (2 g)] In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.	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.	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.	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)
Overall Study STARTED	9	419	421	418
Overall Study COMPLETED	9	375	379	376
Overall Study NOT COMPLETED	0	44	42	42

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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)
Overall Study Non-compliance	2	1	1
Overall Study Randomized by error/screen failure	0	1	0
Overall Study Distance to center	1	1	0
Overall Study Adverse Event	11	6	12
Overall Study Death	2	2	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Physician Decision	0	2	0
Overall Study Withdrawal by Subject	7	3	4
Overall Study Due to key hepatic values	1	0	0
Overall Study Unable to contact patient	3	1	2
Overall Study Patient unable to come to site/attend visit	6	11	6
Overall Study Patient did not want another infusion	3	3	2
Overall Study Vacation	1	0	0
Overall Study Patient decision	7	9	14
Overall Study Missed IV due to pharmacy error	0	1	0

Baseline Characteristics

A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Lead-in [CSL112 (2 g)] n=9 Participants In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.	CSL112 (2 g) n=419 Participants 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.	CSL112 (6 g) n=421 Participants 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.	Placebo n=418 Participants 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)	Total n=1267 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	306 Participants n=107 Participants	296 Participants n=206 Participants	301 Participants n=7 Participants	910 Participants n=31 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	113 Participants n=107 Participants	125 Participants n=206 Participants	117 Participants n=7 Participants	357 Participants n=31 Participants
Age, Continuous	59.0 years STANDARD_DEVIATION 7.19 • n=99 Participants	57.7 years STANDARD_DEVIATION 10.15 • n=107 Participants	59.2 years STANDARD_DEVIATION 9.87 • n=206 Participants	58.1 years STANDARD_DEVIATION 10.57 • n=7 Participants	58.3 years STANDARD_DEVIATION 10.21 • n=31 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	82 Participants n=107 Participants	98 Participants n=206 Participants	77 Participants n=7 Participants	259 Participants n=31 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	337 Participants n=107 Participants	323 Participants n=206 Participants	341 Participants n=7 Participants	1008 Participants n=31 Participants
Region of Enrollment Hungary	9 participants n=99 Participants	66 participants n=107 Participants	67 participants n=206 Participants	69 participants n=7 Participants	211 participants n=31 Participants
Region of Enrollment United States	0 participants n=99 Participants	59 participants n=107 Participants	54 participants n=206 Participants	54 participants n=7 Participants	167 participants n=31 Participants
Region of Enrollment Czechia	0 participants n=99 Participants	33 participants n=107 Participants	35 participants n=206 Participants	36 participants n=7 Participants	104 participants n=31 Participants
Region of Enrollment United Kingdom	0 participants n=99 Participants	3 participants n=107 Participants	2 participants n=206 Participants	4 participants n=7 Participants	9 participants n=31 Participants
Region of Enrollment Spain	0 participants n=99 Participants	6 participants n=107 Participants	5 participants n=206 Participants	6 participants n=7 Participants	17 participants n=31 Participants
Region of Enrollment Canada	0 participants n=99 Participants	9 participants n=107 Participants	9 participants n=206 Participants	7 participants n=7 Participants	25 participants n=31 Participants
Region of Enrollment Austria	0 participants n=99 Participants	2 participants n=107 Participants	3 participants n=206 Participants	2 participants n=7 Participants	7 participants n=31 Participants
Region of Enrollment Netherlands	0 participants n=99 Participants	48 participants n=107 Participants	48 participants n=206 Participants	49 participants n=7 Participants	145 participants n=31 Participants
Region of Enrollment Denmark	0 participants n=99 Participants	8 participants n=107 Participants	10 participants n=206 Participants	10 participants n=7 Participants	28 participants n=31 Participants
Region of Enrollment Poland	0 participants n=99 Participants	70 participants n=107 Participants	69 participants n=206 Participants	65 participants n=7 Participants	204 participants n=31 Participants
Region of Enrollment Italy	0 participants n=99 Participants	7 participants n=107 Participants	7 participants n=206 Participants	8 participants n=7 Participants	22 participants n=31 Participants
Region of Enrollment Israel	0 participants n=99 Participants	27 participants n=107 Participants	27 participants n=206 Participants	27 participants n=7 Participants	81 participants n=31 Participants
Region of Enrollment Australia	0 participants n=99 Participants	6 participants n=107 Participants	6 participants n=206 Participants	6 participants n=7 Participants	18 participants n=31 Participants
Region of Enrollment Bulgaria	0 participants n=99 Participants	47 participants n=107 Participants	47 participants n=206 Participants	46 participants n=7 Participants	140 participants n=31 Participants
Region of Enrollment France	0 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants	1 participants n=7 Participants	3 participants n=31 Participants
Region of Enrollment Germany	0 participants n=99 Participants	28 participants n=107 Participants	30 participants n=206 Participants	28 participants n=7 Participants	86 participants n=31 Participants
Renal function from Interactive Web Response System (IWRS) Normal renal function	4 participants n=99 Participants	195 participants n=107 Participants	192 participants n=206 Participants	191 participants n=7 Participants	582 participants n=31 Participants
Renal function from Interactive Web Response System (IWRS) Mild renal impairment	5 participants n=99 Participants	224 participants n=107 Participants	229 participants n=206 Participants	227 participants n=7 Participants	685 participants n=31 Participants

PRIMARY outcome

Timeframe: From baseline (before first infusion) to Day 29.

Population: 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.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=416 Participants 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.	Placebo n=413 Participants 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)	CSL112 (2 g) n=415 Participants 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.
Percent of Participants With Clinically Important Change in Drug-induced Liver Injury	0.5 percentage of participants	0 percentage of participants	1.0 percentage of participants

PRIMARY outcome

Timeframe: From baseline (before first infusion) to Day 29.

Population: SP

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.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=416 Participants 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.	Placebo n=413 Participants 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)	CSL112 (2 g) n=415 Participants 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.
Percent of Participants With Clinically Important Change in Renal Status	0.7 percentage of participants	0.2 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From the start of the first infusion up to approximately 382 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=421 Participants 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.	Placebo n=418 Participants 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)	CSL112 (2 g) n=419 Participants 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.
The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)	5.7 percentage of participants	5.5 percentage of participants	6.4 percentage of participants

SECONDARY outcome

Timeframe: Before first infusion and end of first infusion

Population: 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.

Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=404 Participants 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.	Placebo n=403 Participants 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)	CSL112 (2 g) n=396 Participants 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.
Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants apoA-I	136.1 mg/dL Standard Deviation 54.37	-4.7 mg/dL Standard Deviation 13.46	35.9 mg/dL Standard Deviation 22.13
Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants PC	180.4 mg/dL Standard Deviation 74.4	-1.2 mg/dL Standard Deviation 20.43	57.7 mg/dL Standard Deviation 31.12

SECONDARY outcome

Timeframe: Before first infusion and end of fourth infusion

Population: PK

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=370 Participants 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.	Placebo n=370 Participants 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)	CSL112 (2 g) n=366 Participants 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.
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants apoA-I	158.0 mg/dL Standard Deviation 55.07	5.4 mg/dL Standard Deviation 26.47	52.1 mg/dL Standard Deviation 55.03
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants PC	186.8 mg/dL Standard Deviation 79.39	-12.9 mg/dL Standard Deviation 42.05	48.7 mg/dL Standard Deviation 55.75

SECONDARY outcome

Timeframe: Before first infusion and end of first infusion

Population: PK

apoA-I and PC are analytes of CSL112

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=175 Participants 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.	Placebo n=183 Participants 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)	CSL112 (2 g) n=185 Participants 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.
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function apoA-I	134.5 mg/dL Standard Deviation 48.25	-4.0 mg/dL Standard Deviation 16.95	36.0 mg/dL Standard Deviation 25.35
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function PC	177.4 mg/dL Standard Deviation 67.93	-1.3 mg/dL Standard Deviation 25.74	58.0 mg/dL Standard Deviation 37.06

SECONDARY outcome

Timeframe: Before first infusion and end of fourth infusion

Population: PK

apoA-I and PC are analytes of CSL112

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=160 Participants 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.	Placebo n=171 Participants 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)	CSL112 (2 g) n=173 Participants 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.
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function apoA-I	154.3 mg/dL Standard Deviation 53.64	4.8 mg/dL Standard Deviation 28.19	54.7 mg/dL Standard Deviation 74.94
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function PC	182.0 mg/dL Standard Deviation 80.74	-12.3 mg/dL Standard Deviation 44.89	47.6 mg/dL Standard Deviation 64.67

SECONDARY outcome

Timeframe: Before first infusion and end of first infusion

Population: PK

apoA-I and PC are analytes of CSL112

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=212 Participants 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.	Placebo n=203 Participants 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)	CSL112 (2 g) n=189 Participants 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.
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment apoA-I	135.5 mg/dL Standard Deviation 59.05	-5.3 mg/dL Standard Deviation 9.7	35.9 mg/dL Standard Deviation 19.05
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment PC	180.6 mg/dL Standard Deviation 79.50	-0.8 mg/dL Standard Deviation 14.95	57.8 mg/dL Standard Deviation 24.71

SECONDARY outcome

Timeframe: Before first infusion and end of fourth infusion

Population: PK

apoA-I and PC are analytes of CSL112

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=195 Participants 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.	Placebo n=183 Participants 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)	CSL112 (2 g) n=171 Participants 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.
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment apoA-I	158.4 mg/dL Standard Deviation 56.19	6.0 mg/dL Standard Deviation 25.68	49.3 mg/dL Standard Deviation 27.63
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment PC	188.3 mg/dL Standard Deviation 79.39	-13.2 mg/dL Standard Deviation 40.08	50.6 mg/dL Standard Deviation 47.17

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: The Pharmacokinetic/Pharmacodynamic (PK/PD) population was a subset of subjects from the main study who consented to participate in the PK/PD substudy.

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=21 Participants 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.	Placebo n=18 Participants 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)	CSL112 (2 g) n=24 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants apoA-I	147.4 mg/dL Standard Deviation 31.9	7.1 mg/dL Standard Deviation 7.9	42.6 mg/dL Standard Deviation 11.2
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants PC	196.4 mg/dL Standard Deviation 36.2	11.1 mg/dL Standard Deviation 15.2	67.7 mg/dL Standard Deviation 19.2

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=19 Participants 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.	Placebo n=17 Participants 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)	CSL112 (2 g) n=22 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants apoA-I	164.3 mg/dL Standard Deviation 33.4	12.7 mg/dL Standard Deviation 19.5	57.6 mg/dL Standard Deviation 19.5
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants PC	187.4 mg/dL Standard Deviation 49.9	9.1 mg/dL Standard Deviation 43.1	59.0 mg/dL Standard Deviation 34.2

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=13 Participants 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)	CSL112 (2 g) n=13 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	135.1 mg/dL Standard Deviation 22.8	7.8 mg/dL Standard Deviation 8.3	40.9 mg/dL Standard Deviation 12.0
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	184.9 mg/dL Standard Deviation 31.5	13.0 mg/dL Standard Deviation 16.5	61.9 mg/dL Standard Deviation 21.0

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	Placebo n=12 Participants 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)	CSL112 (2 g) n=12 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	149.0 mg/dL Standard Deviation 26.9	17.5 mg/dL Standard Deviation 20.3	60.8 mg/dL Standard Deviation 19.2
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	176.1 mg/dL Standard Deviation 54.0	20.1 mg/dL Standard Deviation 44.2	45.8 mg/dL Standard Deviation 26.4

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=11 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	160.7 mg/dL Standard Deviation 37.0	5.2 mg/dL Standard Deviation 7.3	44.6 mg/dL Standard Deviation 10.2
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	211.3 mg/dL Standard Deviation 37.5	6.0 mg/dL Standard Deviation 10.8	74.6 mg/dL Standard Deviation 14.7

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Cmax is the maximal plasma concentration.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	169.7 mg/dL Standard Deviation 29.3	1.0 mg/dL Standard Deviation 12.1	53.7 mg/dL Standard Deviation 20.1
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	190.4 mg/dL Standard Deviation 46.7	-17.4 mg/dL Standard Deviation 28.9	74.8 mg/dL Standard Deviation 37.0

SECONDARY outcome

Timeframe: Before and for 7 days after the first infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=21 Participants 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.	Placebo n=18 Participants 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)	CSL112 (2 g) n=24 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants apoA-I	2.17 hours Interval 2.0 to 4.0	46.8 hours Interval 0.0 to 216.3	2.23 hours Interval 1.7 to 236.9
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants PC	2.17 hours Interval 2.0 to 4.0	5.29 hours Interval 0.0 to 188.9	2.23 hours Interval 1.7 to 8.4

SECONDARY outcome

Timeframe: Before and for 7 days after the fourth infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=19 Participants 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.	Placebo n=17 Participants 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)	CSL112 (2 g) n=22 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants apoA-I	2.25 hours Interval 2.0 to 4.2	119 hours Interval 0.0 to 332.9	2.13 hours Interval 2.0 to 23.5
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants PC	2.25 hours Interval 2.0 to 4.2	46.93 hours Interval 0.0 to 187.3	2.17 hours Interval 2.0 to 53.1

SECONDARY outcome

Timeframe: Before and for 7 days after the first infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=13 Participants 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)	CSL112 (2 g) n=13 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	2.17 hours Interval 2.0 to 3.4	96.1 hours Interval 0.0 to 216.3	2.25 hours Interval 1.7 to 236.9
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	2.17 hours Interval 2.0 to 3.4	8.1 hours Interval 0.0 to 188.9	2.22 hours Interval 1.7 to 8.4

SECONDARY outcome

Timeframe: Before and for 7 days after the fourth infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	Placebo n=12 Participants 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)	CSL112 (2 g) n=12 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	2.17 hours Interval 2.0 to 2.4	119.3 hours Interval 0.0 to 332.9	2.13 hours Interval 2.1 to 3.5
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	2.17 hours Interval 2.0 to 2.4	29 hours Interval 0.0 to 187.3	2.17 hours Interval 2.1 to 53.1

SECONDARY outcome

Timeframe: Before and for 7 days after the first infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=11 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	2.22 hours Interval 2.1 to 4.0	0 hours Interval 0.0 to 117.9	2.18 hours Interval 2.1 to 3.4
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	2.22 hours Interval 2.1 to 4.0	0 hours Interval 0.0 to 5.3	2.28 hours Interval 2.1 to 5.0

SECONDARY outcome

Timeframe: Before and for 7 days after the fourth infusion

Population: PK/PD

Tmax is time to maximal plasma concentration

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	2.25 hours Interval 2.1 to 4.2	72.5 hours Interval 0.0 to 166.5	2.17 hours Interval 2.0 to 23.5
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	2.25 hours Interval 2.1 to 4.2	48.3 hours Interval 9.0 to 166.5	2.17 hours Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=21 Participants 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.	Placebo n=18 Participants 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)	CSL112 (2 g) n=24 Participants 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.
Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants apoA-I	4819 mg•h/dL Standard Deviation 2580	-766 mg•h/dL Standard Deviation 2248	1703 mg•h/dL Standard Deviation 2149
Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants PC	869 mg•h/dL Standard Deviation 3796	-2096 mg•h/dL Standard Deviation 3372	-66.12 mg•h/dL Standard Deviation 3653

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=19 Participants 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.	Placebo n=17 Participants 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)	CSL112 (2 g) n=22 Participants 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.
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants apoA-I	8985 mg•h/dL Standard Deviation 4263	747 mg•h/dL Standard Deviation 3226	4579 mg•h/dL Standard Deviation 2705
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants PC	2499 mg•h/dL Standard Deviation 7662	-2185 mg•h/dL Standard Deviation 5189	70.7 mg•h/dL Standard Deviation 5327

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=13 Participants 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)	CSL112 (2 g) n=13 Participants 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.
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	3762 mg•h/dL Standard Deviation 2367	-516 mg•h/dL Standard Deviation 2091	1278 mg•h/dL Standard Deviation 1742
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	-137 mg•h/dL Standard Deviation 4057	-1337 mg•h/dL Standard Deviation 2590	-1382 mg•h/dL Standard Deviation 2853

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	Placebo n=12 Participants 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)	CSL112 (2 g) n=12 Participants 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.
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	8609 mg•h/dL Standard Deviation 4500	1632 mg•h/dL Standard Deviation 3235	4513 mg•h/dL Standard Deviation 2701
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	3609 mg•h/dL Standard Deviation 10232	-542 mg•h/dL Standard Deviation 4480	-2130 mg•h/dL Standard Deviation 4691

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=11 Participants 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.
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment apoA-I	5917 mg•h/dL Standard Deviation 2568	-1416 mg•h/dL Standard Deviation 2763	2205 mg•h/dL Standard Deviation 2543
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment PC	1828 mg•h/dL Standard Deviation 3661	-4068 mg•h/dL Standard Deviation 4634	1489 mg•h/dL Standard Deviation 4003

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

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 \[AUC0 - last\]

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	8786 mg•h/dL Standard Deviation 4201	-1376 mg•h/dL Standard Deviation 2205	4659 mg•h/dL Standard Deviation 2854
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	1541 mg•h/dL Standard Deviation 5815	-6128 mg•h/dL Standard Deviation 4998	2712 mg•h/dL Standard Deviation 5010

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=21 Participants 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.	Placebo n=18 Participants 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)	CSL112 (2 g) n=24 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants apoA-I (0-24h)	1929 mg•h/dL Standard Deviation 557	-168 mg•h/dL Standard Deviation 158	496 mg•h/dL Standard Deviation 212
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants apoA-I (0-48h)	2903 mg•h/dL Standard Deviation 944	-331 mg•h/dL Standard Deviation 375	731 mg•h/dL Standard Deviation 447
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants apoA-I (0-72h)	3516 mg•h/dL Standard Deviation 1248	-439 mg•h/dL Standard Deviation 632	880 mg•h/dL Standard Deviation 726
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants apoA-I (0-96h)	3943 mg•h/dL Standard Deviation 1581	-541 mg•h/dL Standard Deviation 940	1006 mg•h/dL Standard Deviation 1104
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants apoA-I (0-168h)	4734 mg•h/dL Standard Deviation 2382	-452 mg•h/dL Standard Deviation 1498	1009 mg•h/dL Standard Deviation 1761
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants PC (0-24h)	1545 mg•h/dL Standard Deviation 552	-92 mg•h/dL Standard Deviation 229	508 mg•h/dL Standard Deviation 349
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants PC (0-48h)	1627 mg•h/dL Standard Deviation 872	-315 mg•h/dL Standard Deviation 522	466 mg•h/dL Standard Deviation 744
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants PC (0-72h)	1713 mg•h/dL Standard Deviation 1209	-549 mg•h/dL Standard Deviation 886	418 mg•h/dL Standard Deviation 1251
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants PC (0-96h)	1712 mg•h/dL Standard Deviation 1694	-780 mg•h/dL Standard Deviation 1346	389 mg•h/dL Standard Deviation 1841
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants PC (0-168h)	1273 mg•h/dL Standard Deviation 2764	-1494 mg•h/dL Standard Deviation 2501	-405 mg•h/dL Standard Deviation 3636

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=19 Participants 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.	Placebo n=17 Participants 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)	CSL112 (2 g) n=22 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants apoA-I (0-24h)	2392 mg•h/dL Standard Deviation 655	-57 mg•h/dL Standard Deviation 377	881 mg•h/dL Standard Deviation 422
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants apoA-I (0-48h)	3913 mg•h/dL Standard Deviation 1235	-55 mg•h/dL Standard Deviation 759	1593 mg•h/dL Standard Deviation 798
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants apoA-I (0-72h)	5050 mg•h/dL Standard Deviation 1794	-6 mg•h/dL Standard Deviation 1160	2195 mg•h/dL Standard Deviation 1177
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants apoA-I (0-96h)	6000 mg•h/dL Standard Deviation 2292	90 mg•h/dL Standard Deviation 1590	2741 mg•h/dL Standard Deviation 1526
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants apoA-I (0-168h)	8865 mg•h/dL Standard Deviation 3200	1635 mg•h/dL Standard Deviation 3540	3997 mg•h/dL Standard Deviation 2655
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants PC (0-24h)	1564 mg•h/dL Standard Deviation 1051	-488 mg•h/dL Standard Deviation 772	462 mg•h/dL Standard Deviation 681
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants PC (0-48h)	1765 mg•h/dL Standard Deviation 1948	-902 mg•h/dL Standard Deviation 1433	472 mg•h/dL Standard Deviation 1293
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants PC (0-72h)	1899 mg•h/dL Standard Deviation 2823	-1173 mg•h/dL Standard Deviation 2168	509 mg•h/dL Standard Deviation 1989
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants PC (0-96h)	1951 mg•h/dL Standard Deviation 3681	-1417 mg•h/dL Standard Deviation 2894	518 mg•h/dL Standard Deviation 2679
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants PC (0-168h)	2655 mg•h/dL Standard Deviation 6024	-442 mg•h/dL Standard Deviation 6319	-625 mg•h/dL Standard Deviation 4963

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=13 Participants 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)	CSL112 (2 g) n=13 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I (0-24h)	1653 mg•h/dL Standard Deviation 496	-149 mg•h/dL Standard Deviation 123	418 mg•h/dL Standard Deviation 117
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I (0-48h)	2521 mg•h/dL Standard Deviation 955	-316 mg•h/dL Standard Deviation 332	547 mg•h/dL Standard Deviation 204
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I (0-72h)	3064 mg•h/dL Standard Deviation 1280	-435 mg•h/dL Standard Deviation 579	628 mg•h/dL Standard Deviation 337
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I (0-96h)	3342 mg•h/dL Standard Deviation 1642	-528 mg•h/dL Standard Deviation 883	692 mg•h/dL Standard Deviation 554
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I (0-168h)	3780 mg•h/dL Standard Deviation 2353	-275 mg•h/dL Standard Deviation 1461	821 mg•h/dL Standard Deviation 1387
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC (0-24h)	1347 mg•h/dL Standard Deviation 661	-46 mg•h/dL Standard Deviation 160	364 mg•h/dL Standard Deviation 245
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC (0-48h)	1294 mg•h/dL Standard Deviation 1025	-235 mg•h/dL Standard Deviation 441	145 mg•h/dL Standard Deviation 536
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC (0-72h)	1325 mg•h/dL Standard Deviation 1421	-426 mg•h/dL Standard Deviation 759	-38 mg•h/dL Standard Deviation 946
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC (0-96h)	1218 mg•h/dL Standard Deviation 2005	-569 mg•h/dL Standard Deviation 1162	-256 mg•h/dL Standard Deviation 1415
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC (0-168h)	437 mg•h/dL Standard Deviation 2061	-1089 mg•h/dL Standard Deviation 2188	-1511 mg•h/dL Standard Deviation 3053

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	Placebo n=12 Participants 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)	CSL112 (2 g) n=12 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I (0-24h)	2098 mg•h/dL Standard Deviation 463	20 mg•h/dL Standard Deviation 417	929 mg•h/dL Standard Deviation 396
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I (0-48h)	3459 mg•h/dL Standard Deviation 1001	105 mg•h/dL Standard Deviation 820	1668 mg•h/dL Standard Deviation 753
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I (0-72h)	4497 mg•h/dL Standard Deviation 1478	249 mg•h/dL Standard Deviation 1232	2252 mg•h/dL Standard Deviation 1116
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I (0-96h)	5360 mg•h/dL Standard Deviation 1909	459 mg•h/dL Standard Deviation 1666	2769 mg•h/dL Standard Deviation 1473
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I (0-168h)	8342 mg•h/dL Standard Deviation 2549	2486 mg•h/dL Standard Deviation 2804	3811 mg•h/dL Standard Deviation 2706
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC (0-24h)	1524 mg•h/dL Standard Deviation 1388	-295 mg•h/dL Standard Deviation 819	189 mg•h/dL Standard Deviation 483
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC (0-48h)	1796 mg•h/dL Standard Deviation 2613	-523 mg•h/dL Standard Deviation 1446	-59 mg•h/dL Standard Deviation 952
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC (0-72h)	2000 mg•h/dL Standard Deviation 3773	-605 mg•h/dL Standard Deviation 2133	-306 mg•h/dL Standard Deviation 1544
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC (0-96h)	2078 mg•h/dL Standard Deviation 4905	-633 mg•h/dL Standard Deviation 2772	-573 mg•h/dL Standard Deviation 2204
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC (0-168h)	4584 mg•h/dL Standard Deviation 7822	1253 mg•h/dL Standard Deviation 4446	-3853 mg•h/dL Standard Deviation 3242

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=11 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I (0-24h)	2219 mg•h/dL Standard Deviation 515	-218 mg•h/dL Standard Deviation 238	589 mg•h/dL Standard Deviation 263
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I (0-48h)	3308 mg•h/dL Standard Deviation 847	-370 mg•h/dL Standard Deviation 514	949 mg•h/dL Standard Deviation 560
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I (0-72h)	3998 mg•h/dL Standard Deviation 1152	-451 mg•h/dL Standard Deviation 834	1179 mg•h/dL Standard Deviation 946
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I (0-96h)	4517 mg•h/dL Standard Deviation 1465	-576 mg•h/dL Standard Deviation 1188	1376 mg•h/dL Standard Deviation 1468
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I (0-168h)	5624 mg•h/dL Standard Deviation 2293	-865 mg•h/dL Standard Deviation 1824	1196 mg•h/dL Standard Deviation 2155
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC (0-24h)	1777 mg•h/dL Standard Deviation 353	-212 mg•h/dL Standard Deviation 348	678 mg•h/dL Standard Deviation 386
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC (0-48h)	1968 mg•h/dL Standard Deviation 623	-523 mg•h/dL Standard Deviation 705	845 mg•h/dL Standard Deviation 797
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC (0-72h)	2093 mg•h/dL Standard Deviation 950	-871 mg•h/dL Standard Deviation 1196	956 mg•h/dL Standard Deviation 1393
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC (0-96h)	2194 mg•h/dL Standard Deviation 1351	-1329 mg•h/dL Standard Deviation 1769	1227 mg•h/dL Standard Deviation 2058
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC (0-168h)	2004 mg•h/dL Standard Deviation 3214	2203 mg•h/dL Standard Deviation 3197	1018 mg•h/dL Standard Deviation 4052

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC from baseline to time point t (AUC0-t)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=10 Participants 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.	Placebo n=5 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I (0-24h)	2469 mg•h/dL Standard Deviation 573	-243 mg•h/dL Standard Deviation 170	823 mg•h/dL Standard Deviation 466
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I (0-48h)	4049 mg•h/dL Standard Deviation 1221	-440 mg•h/dL Standard Deviation 436	1503 mg•h/dL Standard Deviation 881
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I (0-72h)	5226 mg•h/dL Standard Deviation 1910	-617 mg•h/dL Standard Deviation 741	2128 mg•h/dL Standard Deviation 1304
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I (0-96h)	6212 mg•h/dL Standard Deviation 2503	-796 mg•h/dL Standard Deviation 1045	2707 mg•h/dL Standard Deviation 1669
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I (0-168h)	8840 mg•h/dL Standard Deviation 3678	-4322 mg•h/dL Standard Deviation 0	4229 mg•h/dL Standard Deviation 2754
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC (0-24h)	1518 mg•h/dL Standard Deviation 799	-950 mg•h/dL Standard Deviation 405	789 mg•h/dL Standard Deviation 760
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC (0-48h)	1650 mg•h/dL Standard Deviation 1474	-1810 mg•h/dL Standard Deviation 1001	1110 mg•h/dL Standard Deviation 1402
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC (0-72h)	1726 mg•h/dL Standard Deviation 2176	-2536 mg•h/dL Standard Deviation 1731	1487 mg•h/dL Standard Deviation 2090
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC (0-96h)	1751 mg•h/dL Standard Deviation 2867	-3297 mg•h/dL Standard Deviation 2471	1826 mg•h/dL Standard Deviation 2706
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC (0-168h)	1316 mg•h/dL Standard Deviation 4998	-12308 mg•h/dL Standard Deviation 0	2603 mg•h/dL Standard Deviation 4295

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=16 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=6 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants apoA-I	6090 mg•h/dL Standard Deviation 3642	—	1425 mg•h/dL Standard Deviation 1297
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants PC	1678 mg•h/dL Standard Deviation 651	6979 mg•h/dL Standard Deviation 0	1850 mg•h/dL Standard Deviation 3120

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=15 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants apoA-I	13570 mg•h/dL Standard Deviation 6965	4615 mg•h/dL Standard Deviation 0	15540 mg•h/dL Standard Deviation 19437
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants PC	12863 mg•h/dL Standard Deviation 16731	—	2015 mg•h/dL Standard Deviation 2855

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	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)	CSL112 (2 g) n=3 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	4505 mg•h/dL Standard Deviation 2528	—	589 mg•h/dL Standard Deviation 17
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	1596 mg•h/dL Standard Deviation 785	—	490 mg•h/dL Standard Deviation 1540

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=5 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=7 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	12422 mg•h/dL Standard Deviation 7399	4615 mg•h/dL Standard Deviation 0	17079 mg•h/dL Standard Deviation 23224
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	16142 mg•h/dL Standard Deviation 17777	—	638 mg•h/dL Standard Deviation 566

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=7 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=4 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	8032 mg•h/dL Standard Deviation 4220	—	1842 mg•h/dL Standard Deviation 1451
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	1761 mg•h/dL Standard Deviation 566	6979 mg•h/dL Standard Deviation 0	3210 mg•h/dL Standard Deviation 4052

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=9 Participants 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.	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)	CSL112 (2 g) n=3 Participants 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.
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	13157 mg•h/dL Standard Deviation 6734	—	11951 mg•h/dL Standard Deviation 7374
Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	12827 mg•h/dL Standard Deviation 18453	—	4769 mg•h/dL Standard Deviation 4128

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=16 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=6 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants apoA-I	53.9 hours Standard Deviation 38.7	—	46.4 hours Standard Deviation 33.1
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants PC	9.7 hours Standard Deviation 7.2	241.2 hours Standard Deviation 0	32.9 hours Standard Deviation 29.6

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=15 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants apoA-I	103.6 hours Standard Deviation 61.1	145 hours Standard Deviation 0	269.1 hours Standard Deviation 292
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants PC	156.3 hours Standard Deviation 245.8	—	21.5 hours Standard Deviation 20.6

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	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)	CSL112 (2 g) n=3 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	41.4 hours Standard Deviation 24.1	—	7.5 hours Standard Deviation 1.7
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	12.3 hours Standard Deviation 8.9	—	34 hours Standard Deviation 27.7

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=5 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=7 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	96.5 hours Standard Deviation 47.3	145 hours Standard Deviation 0	271.6 hours Standard Deviation 317.4
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	121.1 hours Standard Deviation 102.7	—	9.1 hours Standard Deviation 9.3

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=7 Participants 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.	Placebo n=1 Participants 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)	CSL112 (2 g) n=4 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	66.4 hours Standard Deviation 51.4	—	65.9 hours Standard Deviation 17.5
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	7.1 hours Standard Deviation 4.4	241.2 hours Standard Deviation 0	31.8 hours Standard Deviation 37.7

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=9 Participants 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.	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)	CSL112 (2 g) n=3 Participants 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.
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	99.2 hours Standard Deviation 68.2	—	263.1 hours Standard Deviation 285.4
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	185.6 hours Standard Deviation 306.5	—	46.3 hours Standard Deviation 2.2

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=16 Participants 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.	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)	CSL112 (2 g) n=6 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants apoA-I	0.15 L/h Standard Deviation 0.13	—	0.29 L/h Standard Deviation 0.27
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants PC	0.61 L/h Standard Deviation 0.26	—	0.32 L/h Standard Deviation 0.26

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=16 Participants 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.	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)	CSL112 (2 g) n=17 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants apoA-I	0.07 L/h Standard Deviation 0.02	—	0.09 L/h Standard Deviation 0.1
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants PC	0.57 L/h Standard Deviation 1.12	—	0.11 L/h Standard Deviation 0.09

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	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)	CSL112 (2 g) n=2 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	0.19 L/h Standard Deviation 0.17	—	0.33 L/h Standard Deviation 0.01
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	0.68 L/h Standard Deviation 0.35	—	0.41 L/h Standard Deviation 0.38

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=6 Participants 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.	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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	0.08 L/h Standard Deviation 0.02	—	0.11 L/h Standard Deviation 0.12
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	0.19 L/h Standard Deviation 0.12	—	0.24 L/h Standard Deviation 0

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=7 Participants 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.	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)	CSL112 (2 g) n=4 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	0.09 L/h Standard Deviation 0.05	—	0.27 L/h Standard Deviation 0.35
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	0.54 L/h Standard Deviation 0.13	—	0.26 L/h Standard Deviation 0.23

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=9 Participants 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.	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)	CSL112 (2 g) n=7 Participants 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.
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	0.08 L/h Standard Deviation 0.03	—	0.05 L/h Standard Deviation 0.02
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	1.01 L/h Standard Deviation 1.63	—	0.08 L/h Standard Deviation 0.07

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=16 Participants 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.	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)	CSL112 (2 g) n=6 Participants 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.
Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants apoA-I	7.4 Liters Standard Deviation 3.1	—	33.4 Liters Standard Deviation 64.7
Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants PC	14.4 Liters Standard Deviation 33.3	—	6.1 Liters Standard Deviation 4.4

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=15 Participants 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.	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)	CSL112 (2 g) n=10 Participants 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.
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants apoA-I	9.4 Liters Standard Deviation 4.7	—	18.7 Liters Standard Deviation 16.6
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants PC	58.3 Liters Standard Deviation 94.9	—	10.7 Liters Standard Deviation 7.5

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=8 Participants 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.	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)	CSL112 (2 g) n=2 Participants 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.
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function apoA-I	8.1 Liters Standard Deviation 3.8	—	3.8 Liters Standard Deviation 0.9
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function PC	24.7 Liters Standard Deviation 47.2	—	8.3 Liters Standard Deviation 7.7

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=5 Participants 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.	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)	CSL112 (2 g) n=7 Participants 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.
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function apoA-I	9.4 Liters Standard Deviation 2.5	—	18.7 Liters Standard Deviation 16.1
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function PC	17 Liters Standard Deviation 10.3	—	11.4 Liters Standard Deviation 8.3

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after first infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=7 Participants 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.	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)	CSL112 (2 g) n=4 Participants 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.
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment apoA-I	6.4 Liters Standard Deviation 2.3	—	48.2 Liters Standard Deviation 78.1
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment PC	4 Liters Standard Deviation 1.5	—	4.7 Liters Standard Deviation 1.3

SECONDARY outcome

Timeframe: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Population: PK/PD

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=9 Participants 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.	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)	CSL112 (2 g) n=3 Participants 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.
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment apoA-I	9.4 Liters Standard Deviation 5.9	—	18.7 Liters Standard Deviation 21.3
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment PC	83.1 Liters Standard Deviation 114	—	9.3 Liters Standard Deviation 8.2

SECONDARY outcome

Timeframe: From the start of first infusion, up to approximately Day 382

Population: SP

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.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=416 Participants 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.	Placebo n=413 Participants 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)	CSL112 (2 g) n=415 Participants 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.
Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions	28.4 percentage of participants	23.5 percentage of participants	31.8 percentage of participants

SECONDARY outcome

Timeframe: From the start of first infusion, up to approximately Day 382

Population: SP

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=416 Participants 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.	Placebo n=413 Participants 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)	CSL112 (2 g) n=415 Participants 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.
Percent of Participants With Any Adverse Event (AE)	51.4 percentage of participants	49.6 percentage of participants	50.6 percentage of participants

SECONDARY outcome

Timeframe: From the start of first infusion, up to approximately Day 112

Population: SP

The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=416 Participants 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.	Placebo n=413 Participants 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)	CSL112 (2 g) n=415 Participants 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.
Percent of Participants Who Experience Bleeding Events	9.1 percentage of participants	12.3 percentage of participants	9.2 percentage of participants

SECONDARY outcome

Timeframe: Before first infusion, up to approximately Day 112

Population: SP

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=389 Participants 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.	Placebo n=380 Participants 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)	CSL112 (2 g) n=377 Participants 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.
Change From Baseline in Serum Antibodies to CSL112 and apoA-I Anti-CSL112 antibody	0 Titer Standard Deviation 0.2	0 Titer Standard Deviation 0.2	0 Titer Standard Deviation 0.14
Change From Baseline in Serum Antibodies to CSL112 and apoA-I Anti-apoA-I antibody	0 Titer Standard Deviation 0.14	0 Titer Standard Deviation 0.1	0 Titer Standard Deviation 0.09

SECONDARY outcome

Timeframe: Study Day 112

Population: Serology population are a random subset of participants that was selected and had their samples tested for the presence of parvovirus B19.

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=60 Participants 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.	Placebo n=60 Participants 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)	CSL112 (2 g) n=60 Participants 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.
Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19 IgG	48 participants	44 participants	40 participants
Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19 IgM	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Study Day 112

Population: Serology population

Outcome measures

Outcome measures
Measure	CSL112 (6 g) n=60 Participants 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.	Placebo n=60 Participants 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)	CSL112 (2 g) n=60 Participants 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.
Number of Participants With Parvovirus B19 DNA in Serum Not detected	60 participants	59 participants	57 participants
Number of Participants With Parvovirus B19 DNA in Serum < 101 IU/mL	0 participants	1 participants	1 participants
Number of Participants With Parvovirus B19 DNA in Serum Missing	0 participants	0 participants	2 participants

Adverse Events

Safety Lead-in [CSL112 (2 g)]

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

CSL112 (2 g)

Serious events: 66 serious events

Other events: 15 other events

Deaths: 5 deaths

CSL112 (6 g)

Serious events: 54 serious events

Other events: 23 other events

Deaths: 4 deaths

Placebo

Serious events: 55 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Safety Lead-in [CSL112 (2 g)] n=9 participants at risk In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.	CSL112 (2 g) n=415 participants at risk CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.	CSL112 (6 g) n=416 participants at risk CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.	Placebo n=413 participants at risk 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.
Vascular disorders Deep vein thrombosis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Vascular disorders Hypertension	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Vascular disorders Hypotension	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 2 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Vascular disorders Shock haemorrhagic	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Vascular disorders Arterial haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Vascular disorders Hypertensive crisis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Vascular disorders Peripheral artery occlusion	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.48% 2/413 • Number of events 2 • Up to 382 days for each participant
Vascular disorders Thrombosis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
General disorders Chest pain	0.00% 0/9 • Up to 382 days for each participant	2.2% 9/415 • Number of events 10 • Up to 382 days for each participant	0.96% 4/416 • Number of events 4 • Up to 382 days for each participant	1.2% 5/413 • Number of events 5 • Up to 382 days for each participant
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.96% 4/416 • Number of events 4 • Up to 382 days for each participant	0.97% 4/413 • Number of events 6 • Up to 382 days for each participant
General disorders Asthenia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
General disorders Multiple organ dysfunction syndrome	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
General disorders Pyrexia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
General disorders Vascular stent restenosis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.48% 2/413 • Number of events 3 • Up to 382 days for each participant
General disorders Vascular stent thrombosis	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Psychiatric disorders Anxiety	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Psychiatric disorders Depressed mood	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Psychiatric disorders Depression	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Psychiatric disorders Mental disorder	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Reproductive system and breast disorders Ovarian cyst	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Injury, poisoning and procedural complications Contusion	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Injury, poisoning and procedural complications Rib fracture	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 2 • Up to 382 days for each participant
Investigations Ejection fraction decreased	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Angina pectoris	0.00% 0/9 • Up to 382 days for each participant	1.2% 5/415 • Number of events 5 • Up to 382 days for each participant	1.4% 6/416 • Number of events 7 • Up to 382 days for each participant	1.2% 5/413 • Number of events 6 • Up to 382 days for each participant
Cardiac disorders Angina unstable	0.00% 0/9 • Up to 382 days for each participant	1.4% 6/415 • Number of events 6 • Up to 382 days for each participant	0.72% 3/416 • Number of events 3 • Up to 382 days for each participant	0.97% 4/413 • Number of events 5 • Up to 382 days for each participant
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Up to 382 days for each participant	0.72% 3/415 • Number of events 3 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Coronary artery stenosis	0.00% 0/9 • Up to 382 days for each participant	0.72% 3/415 • Number of events 4 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Myocardial infarction	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.72% 3/416 • Number of events 3 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Ventricular tachycardia	0.00% 0/9 • Up to 382 days for each participant	0.72% 3/415 • Number of events 3 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Cardiac failure congestive	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 4 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.48% 2/413 • Number of events 2 • Up to 382 days for each participant
Cardiac disorders Acute coronary syndrome	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Atrial tachycardia	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Bradycardia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Cardiac aneurysm	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Cardiac arrest	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Cardiac asthma	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Intracardiac thrombus	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Myocardial ischaemia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Palpitations	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Prinzmetal angina	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Sinus bradycardia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Ventricular fibrillation	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Ventricular septal defect acquired	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Cardiac failure acute	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Cardiomyopathy	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Coronary artery dissection	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Coronary artery occlusion	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Mitral valve incompetence	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Supraventricular tachycardia	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Cardiac disorders Cardiac failure	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.72% 3/415 • Number of events 3 • Up to 382 days for each participant	0.72% 3/416 • Number of events 4 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Syncope	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.48% 2/416 • Number of events 2 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Nervous system disorders Paraesthesia	0.00% 0/9 • Up to 382 days for each participant	0.72% 3/415 • Number of events 4 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Carotid artery stenosis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Carotid artery disease	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 2 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Diabetic neuropathy	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Lumbar radiculopathy	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Sciatica	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Nervous system disorders Cerebral ischaemia	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Nervous system disorders Cluster headache	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Nervous system disorders Dizziness	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Nervous system disorders Presyncope	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Eye disorders Visual impairment	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.48% 2/416 • Number of events 3 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Gastritis	0.00% 0/9 • Up to 382 days for each participant	0.48% 2/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Chronic gastritis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Crohn's disease	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 3 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Mechanical ileus	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Pancreatitis acute	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 2 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Gastrointestinal disorders Pancreatitis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Renal and urinary disorders Postrenal failure	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Hepatobiliary disorders Cholelithiasis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Hepatobiliary disorders Cholestasis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Endocrine disorders Hyperthyroidism	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Bronchitis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Urinary tract infection	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Infections and infestations Clostridial infection	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Clostridium difficile colitis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Escherichia urinary tract infection	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.24% 1/416 • Number of events 1 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Gastroenteritis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Haematoma infection	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Oral fungal infection	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Pneumonia	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 2 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.48% 2/413 • Number of events 2 • Up to 382 days for each participant
Infections and infestations Sepsis	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Septic shock	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Staphylococcal infection	0.00% 0/9 • Up to 382 days for each participant	0.24% 1/415 • Number of events 1 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Infections and infestations Nasopharyngitis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Infections and infestations Postoperative abscess	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Infections and infestations Soft tissue infection	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant
Infections and infestations Urosepsis	0.00% 0/9 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.24% 1/413 • Number of events 1 • Up to 382 days for each participant

Other adverse events

Other adverse events
Measure	Safety Lead-in [CSL112 (2 g)] n=9 participants at risk In the safety lead-in, a small number of subjects (evenly stratified between subjects with normal renal function or mild renal impairment) were administered a single, 2 g infusion of CSL112.	CSL112 (2 g) n=415 participants at risk CSL112 (2 g) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.	CSL112 (6 g) n=416 participants at risk CSL112 (6 g) is to be administered as an IV infusion once weekly for 4 consecutive weeks.	Placebo n=413 participants at risk 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.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Angina pectoris	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Cardiac disorders Extrasystoles	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • Up to 382 days for each participant	3.6% 15/415 • Number of events 19 • Up to 382 days for each participant	5.5% 23/416 • Number of events 24 • Up to 382 days for each participant	2.2% 9/413 • Number of events 10 • Up to 382 days for each participant
Nervous system disorders Syncope	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant
Skin and subcutaneous tissue disorders Skin exfoliation	11.1% 1/9 • Number of events 1 • Up to 382 days for each participant	0.00% 0/415 • Up to 382 days for each participant	0.00% 0/416 • Up to 382 days for each participant	0.00% 0/413 • Up to 382 days for each participant

Additional Information

Trial Registration Coordinator

CSLBehring

Phone: 610-878-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place