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OpenTrials
Completed

NCT Number: NCT01499420

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

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.

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Key information

Conditions

Stable Atherothrombotic Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSL112 (reconstituted high density lipoprotein)

Biological

Single escalating intravenous doses of CSL112

Placebo

Biological

Single intravenous doses of normal saline (0.9%)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.