A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]
Official Title
An adaptive, phase I, randomized, placebo-controlled, sponsor-unblinded, multiple ascending dose study to investigate the safety, tolerability and pharmacokinetics of intravenous CSL112 in healthy volunteers
Objectives
- To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.[1]
- To evaluate role of CSL-112 in decreasing cholesterol-loaded plaques that contribute to cardiovascular disease.[1]
Sponsor
CSL Limited
Timeline
| Timeline | |
| Start Date | January 2011 |
| End Date | June 2011 |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01281774.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Safety study |
| Interventional Model | Parallel assignment |
| Masking | Double blind |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Healthy |
| Intervention | Biological: CSL112 (reconstituted high density lipoprotein) Biological: Placebo (normal saline) |
| Study Arms | Multiple ascending intravenous doses of CSL112 Placebo |
| Population Size | 36 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01281774.
Eligibility Criteria
Inclusion Criteria
- Healthy individual
- Age: 18-55 year old
- Weight ≥ 5 kg
- BMI between 18-42 kg/m2
Exclusion Criteria
- Clinically significant medical condition or disease
- Abnormal lab test result
- History of alcohol or other substance abuse
Outcomes
Primary Outcomes
Safety and tolerability defined as rate of clinically-associated adverse events that occur within 14 days of CSL112 infusion.[1]
Secondary Outcomes
Evaluation of lipoprotein pharmacokinetics during a time frame of 10 days following CSL112 infusion and measurement of plasma levels of lipoprotein.[1]
Publications
Results
- Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers of cholesterol transport, including preBeta1-HDL and global cholesterol efflux as measured by activity of ATP-binding cassette transporter (ABCA1) cells.[1]
- Serum preBeta1-HDL elevation was up to 20-fold.[1]
- The infusion of CSL112 caused a dose-dependent increase of all biomarkers. Levels were consistent in magnitude and time course following the first and last infusions.[1]
- 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.[1]
- Multiple infusions of CSL112 cause a greater efflux of cholesterol from tissues to HDL when compared with a single infusion.[1]
- There were no observed changes in the baseline of other lipoproteins.[1]
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.[1]