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

Phase 2

Completed

• Conditions: Stable Atherothrombotic Disease
• Interventions: Biological: CSL112 (reconstituted high density lipoprotein); Biological: Placebo

• Registration Number: NCT01499420
• Lead Sponsor: CSL Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Study Start: 2012-02
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-08
• Disposition First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Disposition First Posted: 2014-02-06
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSL112	CSL112 (reconstituted high density lipoprotein)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety	14 days	The frequency of study product-related adverse events
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)	14 days	Number of subjects with clinically significant elevation of ALT or AST

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Study Site; 🇺🇸 Rapid City, South Dakota, United States