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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01499420
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
CSL Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stable Atherothrombotic Disease Biological: CSL112 (reconstituted high density lipoprotein) Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL112 Biological: CSL112 (reconstituted high density lipoprotein)
Single escalating intravenous doses of CSL112
Placebo Comparator: Placebo Biological: Placebo
Single intravenous doses of normal saline (0.9%)


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 14 days ]
    The frequency of study product-related adverse events

  2. 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


Secondary Outcome Measures :
  1. Pharmacokinetic profile of apolipoprotein A-I (apoA-I) [ Time Frame: 9 days ]
    Plasma apoA-I concentration with and without baseline correction

  2. Plasma apoA-I area under the curve (AUC) [ Time Frame: 9 days ]
  3. Plasma apoA-I Cmax [ Time Frame: 9 days ]
  4. Plasma apoA-I Tmax [ Time Frame: 9 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499420


Locations
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United States, California
Study Site
Chula Vista, California, United States, 91911
United States, Florida
Study Site
Jacksonville, Florida, United States, 32209
Study Site
Miami, Florida, United States, 33126
United States, Kentucky
Study Site
Lexington, Kentucky, United States, 40536
Study Site
Madisonville, Kentucky, United States, 42431
United States, Maine
Study Site
Auburn, Maine, United States, 04210
United States, Maryland
Study Site
Baltimore, Maryland, United States, 21215
United States, Michigan
Study Site
Petoskey, Michigan, United States, 49770
United States, North Carolina
Study Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Study Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Study Site
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
CSL Limited
Investigators
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Study Director: Dr. Denise D'Andrea CSL Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01499420    
Other Study ID Numbers: CSLCT-HDL-10-70a
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: January 2014