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

Acute Myocardial Infarction Clinical Trial

Official title:

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108262
• Other study ID #: CSLCT-HDL-12-77
• Secondary ID: 2013-003458-26
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1267
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.

Exclusion Criteria:

• Ongoing hemodynamic instability

• Evidence of hepatobiliary disease

• Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis

• Evidence of unstable renal function

• History of acute kidney injury after previous exposure to an intravenous contrast agent.

• Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components

• Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Biological:
• CSL112
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
0.9% weight/volume sodium chloride solution (ie, normal saline)

Locations

Country	Name	City	State
Australia	Study Site 10005	Adelaide	South Australia
Australia	Study Site 10006	Epping	Victoria
Australia	Study Site 10007	Geelong	Victoria
Australia	Study Site 10002	Herston	Queensland
Australia	Study Site 10012	Woodville South	South Australia
Austria	Study Site 11004	Innsbruck
Austria	Study Site 11002	Vienna
Austria	Study Site 11001	Wien
Bulgaria	Study Site 12005	Blagoevgrad
Bulgaria	Study Site 12008	Burgas
Bulgaria	Study Site 12006	Dobrich
Bulgaria	Study Site 12021	Haskovo
Bulgaria	Study Site 12009	Pazardzhik
Bulgaria	Study Site 12019	Pazardzhik
Bulgaria	Study Site 12016	Pleven
Bulgaria	Study Site 12014	Plovdiv
Bulgaria	Study Site 12018	Plovdiv
Bulgaria	Study Site 12017	Sandanski
Bulgaria	Study Site 12001	Sofia
Bulgaria	Study Site 12003	Sofia
Bulgaria	Study Site 12004	Sofia
Bulgaria	Study Site 12010	Sofia
Bulgaria	Study Site 12012	Sofia
Bulgaria	Study Site 12013	Sofia
Bulgaria	Study Site 12011	Varna
Bulgaria	Study Site 12002	Veliko Tarnovo
Bulgaria	Study Site 12007	Yambol
Canada	Study Site - 13002	Edmonton	Alberta
Canada	Study Site - 13003	Edmonton	Alberta
Canada	Study Site - 13008	London	Ontario
Canada	Study Site - 13014	Montreal	Quebec
Canada	Study Site - 13010	Newmarket	Ontario
Canada	Study Site - 13017	Penticton	British Columbia
Canada	Study Site - 13007	Quebec
Canada	Study Site - 13019	St. Johns	Newfoundland and Labrador
Canada	Study Site - 13012	Victoria	British Columbia
Czechia	Study Site 14006	Brno
Czechia	Study Site 14010	Brno
Czechia	Study Site 14004	Hradec Kralove
Czechia	Study Site 14012	Jablonec nad Nisou
Czechia	Study Site 14011	Jihlava
Czechia	Study Site 14016	Kolin
Czechia	Study Site 14017	Nachod
Czechia	Study Site 14007	Ostrava
Czechia	Study Site 14003	Pardubice
Czechia	Study Site 14002	Praha 10
Czechia	Study Site 14001	Praha 2
Czechia	Study Site 14015	Praha 2
Czechia	Study Site 14008	Praha 4 - Krc
Czechia	Study Site 14009	Praha 5
Czechia	Study Site 14014	Teplice
Czechia	Study Site 14005	Usti nad Orlici
Denmark	Study Site 15001	Alborg
Denmark	Study Site 15005	Esbjerg
Denmark	Study Site 15002	Hellerup
Denmark	Study Site 15004	Hvidovre
Denmark	Study Site 15003	Odense
France	Study Site - 25008	Nantes cedex	Loire Antlantique
France	Study Site - 25001	Paris
France	Study Site - 25002	Paris cedex 12	Paris
France	Study Site - 25004	Pau	Pyrenees Atlantiques
France	Study Site - 25003	Pessac	Gironde
France	Study Site - 25005	Toulouse cedex 3	Haute Garonne
Germany	Study Site 17002	Berlin
Germany	Study Site 17003	Berlin
Germany	Study Site 17005	Berlin	Berin
Germany	Study Site 17009	Berlin
Germany	Study Site 17014	Franfurt	Hessen
Germany	Study Site 17001	Freiburg	Baden Wuerttemberg
Germany	Study Site 17006	Hamburg
Germany	Study Site 17012	Hannover	Niedersachsen
Germany	Study Site 17010	Ludwigshafen	Rheinland Pfalz
Germany	Study Site 17007	Luedenscheid	Nordrhein Westfalen
Germany	Study Site 17011	Mainz	Rheinland Pfalz
Hungary	Study Site 18001	Budapest
Hungary	Study Site 18005	Budapest
Hungary	Study Site 18008	Budapest
Hungary	Study Site 18002	Gyor
Hungary	Study Site 18007	Nyiregyhaza
Hungary	Study Site 18003	Pecs
Hungary	Study Site 18009	Szeged
Hungary	Study Site 18006	Szolnok
Israel	Study Site 19010	Ashkelon
Israel	Study Site 19006	Beer Sheva
Israel	Study Site 19005	Haifa
Israel	Study Site 19004	Holon
Israel	Study Site 19003	Jerusalem
Israel	Study Site 19007	Jerusalem
Israel	Study Site 19002	Nahariya
Israel	Study Site 19009	Ramat Gan
Israel	Study Site 19008	Safed
Italy	Study Site 20009	Benevento
Italy	Study Site 20003	Legnano	Milano
Italy	Study Site 20002	Magenta	Milano
Italy	Study Site 20011	Napoli
Italy	Study Site 20007	Rimini
Italy	Study Site 20012	Roma
Italy	Study Site 20008	Rozzano	Milano
Italy	Study Site 20001	Terni
Italy	Study Site 20006	Udine
Netherlands	Study Site 21001	Alkmaar
Netherlands	Study Site 21006	Amsterdam
Netherlands	Study Site 21013	Amsterdam
Netherlands	Study Site 21016	Amsterdam
Netherlands	Study Site 21004	Ede
Netherlands	Study Site 21014	Leeuwarden
Netherlands	Study Site 21003	Nieuwegein
Netherlands	Study Site 21008	Nijmegen
Netherlands	Study Site 21009	Rotterdam
Netherlands	Study Site 21010	Sneek
Netherlands	Study Site 21015	Tilburg
Netherlands	Study Site 21011	Venlo
Poland	Study Site - 22015	Gdansk
Poland	Study Site - 22010	Grodzisk Mazowiecki
Poland	Study Site - 22012	Inowroclaw
Poland	Study Site 22009	Kielce
Poland	Study Site - 22007	Krakow
Poland	Study Site - 22014	Lodz
Poland	Study Site - 22013	Starogard Gdanski
Poland	Study Site - 22006	Walbrzych
Poland	Study Site - 22008	Warszawa
Poland	Study Site - 22016	Wejherowo
Poland	Study Site - 22005	Wroclaw
Spain	Study Site - 23012	A Coruna	La Coruna
Spain	Study Site - 23001	Barcelona
Spain	Study Site - 23002	Barcelona
Spain	Study Site - 23005	Barcelona
Spain	Study Site - 23010	L'Hospitalet de Llobregat	Barcelona
Spain	Study Site - 23003	Madrid
Spain	Study Site - 23004	Madrid
Spain	Study Site - 23013	Madrid
Spain	Study Site - 23007	Malaga
Spain	Study Site - 23006	Santiago de Compostela	La Coruna
Spain	Study Site - 23009	Tarragona
Spain	Study Site - 23011	Valencia
United Kingdom	Study Site - 24004	Basildon	Essex
United Kingdom	Study Site - 24006	Clydebank	Dunbartonshire
United Kingdom	Study Site - 24010	Leicester	Leicestershire
United Kingdom	Study Site - 24003	London	Greater London
United Kingdom	Study Site - 24009	Newcastle upon Tyne	Tyne & Wear
United Kingdom	Study Site 24005	Romford	Essex
United States	Study Site 16208	Alexandria	Louisiana
United States	Study Site 16015	Amarillo	Texas
United States	Study Site 16144	Atlanta	Georgia
United States	Study Site 16062	Auburn	Maine
United States	Study Site 16031	Baltimore	Maryland
United States	Study Site 16079	Bangor	Maine
United States	Study Site 16101	Birmingham	Alabama
United States	Study Site 16112	Boise	Idaho
United States	Study Site 16170	Bridgeport	Connecticut
United States	Study Site 16033	Brooklyn	New York
United States	Study Site 16174	Buffalo	New York
United States	Study Site 16047	Cincinnati	Ohio
United States	Study Site 16148	Clearwater	Florida
United States	Study Site - 16168	Concord	California
United States	Study Site 16168	Concord	California
United States	Study Site 16099	Dallas	Texas
United States	Study Site 16135	Danbury	Connecticut
United States	Study Site 16028	Detroit	Michigan
United States	Study Site 16056	Durham	North Carolina
United States	Study Site 16201	Elizabeth City	North Carolina
United States	Study Site 16179	Elkhart	Indiana
United States	Study Site 16060	Evanston	Illinois
United States	Study Site 16202	Greeneville	Tennessee
United States	Study Site 16039	Greenwood	South Carolina
United States	Study Site 16026	Hershey	Pennsylvania
United States	Study Site 16014	High Point	North Carolina
United States	Study Site 16078	Huntsville	Alabama
United States	Study Site 16102	Indianapolis	Indiana
United States	Study Site 16003	Jacksonville	Florida
United States	Study Site 16100	Lancaster	Pennsylvania
United States	Study Site 16004	Lexington	Kentucky
United States	Study Site 16088	Lexington	Kentucky
United States	Study Site 16130	Littleton	Colorado
United States	Study Site 16016	Louisville	Kentucky
United States	Study Site 16211	Minneapolis	Minnesota
United States	Study Site 16213	New York	New York
United States	Study Site 16061	Petoskey	Michigan
United States	Study Site 16017	Philadelphia	Pennsylvania
United States	Study Site 16018	Rapid City	South Dakota
United States	Study Site 16038	Richmond	Virginia
United States	Study Site 16147	Sacramento	California
United States	Study Site 16234	Saint Paul	Minnesota
United States	Study Site 16022	Torrance	California
United States	Study Site 16063	Tupelo	Mississippi
United States	Study Site 16166	Wausau	Wisconsin
United States	Study Site 16025	West Des Moines	Iowa
United States	Study Site 16241	Wichita Falls	Texas
United States	Study Site 16024	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Clinically Important Change in Drug-induced Liver Injury	A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement.	From baseline (before first infusion) to Day 29.
Primary	Percent of Participants With Clinically Important Change in Renal Status	A clinically important change in renal status is defined as a serum creatinine (Cr) increase to = 1.5 x the baseline value that is confirmed upon repeat measurement.	From baseline (before first infusion) to Day 29.
Secondary	The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)	The MACE is a 4-component composite comprised of the time to the first of the following events: CV death, nonfatal myocardial infarction, ischemic stroke (non-hemorrhagic), and hospitalization for unstable angina.	From the start of the first infusion up to approximately 382 days
Secondary	Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants	Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112	Before first infusion and end of first infusion
Secondary	Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants		Before first infusion and end of fourth infusion
Secondary	Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function	apoA-I and PC are analytes of CSL112	Before first infusion and end of first infusion
Secondary	Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function	apoA-I and PC are analytes of CSL112	Before first infusion and end of fourth infusion
Secondary	Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment	apoA-I and PC are analytes of CSL112	Before first infusion and end of first infusion
Secondary	Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment	apoA-I and PC are analytes of CSL112	Before first infusion and end of fourth infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment	Cmax is the maximal plasma concentration.	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants	Tmax is time to maximal plasma concentration	Before and for 7 days after the first infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants	Tmax is time to maximal plasma concentration	Before and for 7 days after the fourth infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function	Tmax is time to maximal plasma concentration	Before and for 7 days after the first infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function	Tmax is time to maximal plasma concentration	Before and for 7 days after the fourth infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment	Tmax is time to maximal plasma concentration	Before and for 7 days after the first infusion
Secondary	Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment	Tmax is time to maximal plasma concentration	Before and for 7 days after the fourth infusion
Secondary	Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment	Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment	AUC from baseline to time point t (AUC0-t)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for All Participants	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for All Participants	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for Participants With Normal Renal Function	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment	AUC0-8 is plasma area under the curve (AUC0-infinity)	Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary	Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment		Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary	Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions	The overall percentage of subjects: with adverse events (AEs), including local tolerability events, that begin during or within 1 hour of an infusion; or; with AEs considered to be causally related to the test product; or; who experience an AE for which the incidence rate in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.	From the start of first infusion, up to approximately Day 382
Secondary	Percent of Participants With Any Adverse Event (AE)		From the start of first infusion, up to approximately Day 382
Secondary	Percent of Participants Who Experience Bleeding Events	The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)	From the start of first infusion, up to approximately Day 112
Secondary	Change From Baseline in Serum Antibodies to CSL112 and apoA-I		Before first infusion, up to approximately Day 112
Secondary	Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19		Study Day 112
Secondary	Number of Participants With Parvovirus B19 DNA in Serum		Study Day 112