NCT01499420

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: CSL Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stable Atherothrombotic Disease

Interventions

Type	Name	Description
BIOLOGICAL	CSL112 (reconstituted high density lipoprotein)	Single escalating intravenous doses of CSL112
BIOLOGICAL	Placebo	Single intravenous doses of normal saline (0.9%)

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2011-12-26
• Last updated: 2014-02-06

Locations

11 sites across 1 country: United States