A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

High Density Lipoprotein Microchapters
Home
Patient information
Overview
Historical Perspective
Classification
Physiology
Pathophysiology
Causes Low HDL High HDL
Epidemiology and Demographics
Screening
Natural History, Complications and Prognosis
Diagnosis
HDL Laboratory Test
Treatment
Medical Therapy
Prevention
Future or Investigational Therapies
Clinical Trials
Landmark Trials
List of All Trials
Case Studies
Case #1
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers On the Web
Most recent articles
Most cited articles
Review articles
CME Programs
Powerpoint slides
Images
American Roentgen Ray Society Images of A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers All Images X-rays Echo & Ultrasound CT Images MRI
Ongoing Trials at Clinical Trials.gov
US National Guidelines Clearinghouse
NICE Guidance
FDA on A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
CDC on A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers in the news
Blogs on A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
Directions to Hospitals Treating High density lipoprotein
Risk calculators and risk factors for A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

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

Objective

To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.

Timeline

Start Date

June 2010

Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 Final Data Collection for Primary Outcomes End Date

December 2010

Study Completion Date

January 2011

Methods

  Normal  0          false  false  false    EN-US  X-NONE  AR-SA                                       MicrosoftInternetExplorer4

• Phase I study

• Adaptive, randomized, placebo-controlled, double-blinded, sponsor-unblinded, multiple ascending dose study

• Patients enrolled: 36 healthy subjects
• Inclusion criteria: Age 18-55 yo, healthy, weight ≥ 5 kg, and BMI between 18-42 kg/m2

     *Exclusion criteria: Clinically significant medical condition or disease or abnormal lab test result, history of alcohol or other substance abuse.

• 2 study arms: Intravenous placebo infusions composed of 0.9% normal saline and single escalating intravenous doses of CSL112 composed of reconstituted HDL.

Results

• Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers.

• Serum preBeta1-HDL elevation was up to 20-fold.

• Serum preBeta1-HDL and cholesterol efflux capacity peaked after infusion and returned to baseline at 24 hour while there was a 72 hour sustained response for serum HDL following its peak at 24-48 hours after infusion.
• Multiple infusions of CSL112 causes a greater efflux of cholesterol from tissues to HDL when compared with a single infusion.
• No observed changes in the baseline of other lipoproteins.

Conclusion

Single and multiple infusions of CSL-112 in healthy subjects rapidly initiates the reverse cholesterol transport, and this is beneficial in rapidly lowering the risk of recurrent cardiovascular events following acute coronary syndromes.