A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients

A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01499420

Enrollment

Registered

2011-12-26

Start date

2012-02-29

Completion date

2013-03-31

Last updated

2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Atherothrombotic Disease

Brief summary

Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.

Interventions

BIOLOGICALCSL112 (reconstituted high density lipoprotein)

Single escalating intravenous doses of CSL112

BIOLOGICALPlacebo

Single intravenous doses of normal saline (0.9%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Male or female aged 18 years to 80 years. * Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization. * Subjects on a stable medication regimen. * Body weight 50 kg or greater at screening.

Exclusion criteria

* Moderate/severe heart failure or renal impairment. * Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes. * Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization. * Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.) * Known hypersensitivity to the product components

Design outcomes

Primary

Measure	Time frame	Description
Safety	14 days	The frequency of study product-related adverse events
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)	14 days	Number of subjects with clinically significant elevation of ALT or AST

Secondary

Measure	Time frame	Description
Plasma apoA-I area under the curve (AUC)	9 days	—
Plasma apoA-I Cmax	9 days	—
Plasma apoA-I Tmax	9 days	—
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)	9 days	Plasma apoA-I concentration with and without baseline correction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026