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

January 8, 2014 updated by: CSL Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Study Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Study Site
      • Miami, Florida, United States, 33126
        • Study Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Study Site
      • Madisonville, Kentucky, United States, 42431
        • Study Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Study Site
    • Michigan
      • Petoskey, Michigan, United States, 49770
        • Study Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
Single intravenous doses of normal saline (0.9%)
Experimental: CSL112
Biological: CSL112 (reconstituted high density lipoprotein)
Single escalating intravenous doses of CSL112

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Limited

Investigators

  • Study Director: Dr. Denise D'Andrea, CSL Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CSLCT-HDL-10-70a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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