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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

Interventions

  • Biological: CSL112 (reconstituted high density lipoprotein)
    • Single escalating intravenous doses of CSL112
  • Biological: Placebo
    • Single intravenous doses of normal saline (0.9%)

Arms, Groups and Cohorts

  • Experimental: CSL112
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: 14 days
    • The frequency of study product-related adverse events
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CSL Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Denise D’Andrea, Study Director, CSL Limited

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