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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official 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

Objective

To determine the safety, tolerability and pharmacokinetics of a single ascending dose of intravenous infusion of CSL-112 in patients with stable atherothrombotic disease.

Sponsor

CSL Limited

Timeline

Timeline
Start Date	February 2012
End Date	December 2012
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01499420.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 2
Study Design
Allocation	Randomized
Endpoint	Safety study
Interventional Model	Parallel assignment
Masking	Double Blind
Study Details
Primary Purpose	Prevention
Condition	Stable atherothrombotic disease
Intervention	CSL112 (single escalating intravenous doses)
Study Arms	CSL112 (reconstituted high density lipoprotein) Placebo (single intravenous doses of normal saline 0.9%)
Population Size	45

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01499420.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety
- Time Frame: 14 days
- Designated as safety issue: Yes

Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- Time Frame: 14 days
- Designated as safety issue: Yes

Secondary Outcomes

Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
- Time Frame: 9 days
- Designated as safety issue: No
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

Publications

Results

Pending

Conclusion