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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

NCT03004638

Atherosclerosis Cardiovascular Disease

COMPLETED PHASE2

Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)

NCT01178320

Coronary Artery Disease Carotid Artery Diseases Atherosclerosis

COMPLETED

Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease

NCT02388971

Atherosclerotic Cardiovascular Disease

WITHDRAWN PHASE2

Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)

NCT02501018

Critical Limb Ischemia Buerger Disease Thromboangiitis Obliterans +1 more

COMPLETED PHASE2

Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

NCT03297814

Peripheral Arterial Disease

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stable Atherothrombotic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CSL112

Group Type EXPERIMENTAL

CSL112 (reconstituted high density lipoprotein)

Intervention Type BIOLOGICAL

Single escalating intravenous doses of CSL112

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Single intravenous doses of normal saline (0.9%)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CSL112 (reconstituted high density lipoprotein)

Single escalating intravenous doses of CSL112

Intervention Type BIOLOGICAL

Placebo

Single intravenous doses of normal saline (0.9%)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No