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

December 19, 2011
January 8, 2014
February 2012
December 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01499420 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Stable Atherothrombotic Disease
  • Biological: CSL112 (reconstituted high density lipoprotein)
    Single escalating intravenous doses of CSL112
  • Biological: Placebo
    Single intravenous doses of normal saline (0.9%)
  • Experimental: CSL112
    Intervention: Biological: CSL112 (reconstituted high density lipoprotein)
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01499420
CSLCT-HDL-10-70a
Not Provided
CSL Limited
CSL Limited
Not Provided
Study Director: Dr. Denise D'Andrea CSL Limited
CSL Limited
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP