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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01499420
First received: December 19, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Stable Atherothrombotic Disease
Biological: CSL112 (reconstituted high density lipoprotein)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Safety [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The frequency of study product-related adverse events

  • Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Number of subjects with clinically significant elevation of ALT or AST


Secondary Outcome Measures:
  • Pharmacokinetic profile of apolipoprotein A-I (apoA-I) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    Plasma apoA-I concentration with and without baseline correction

  • Plasma apoA-I area under the curve (AUC) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Plasma apoA-I Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Plasma apoA-I Tmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499420

Locations
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
Study Director: Dr. Denise D'Andrea CSL Limited
  More Information

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01499420     History of Changes
Other Study ID Numbers: CSLCT-HDL-10-70a
Study First Received: December 19, 2011
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014