A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers: Difference between revisions
Rim Halaby (talk | contribs) m (Rim Halaby moved page CSL-112 Trial - Phase 1 to A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers) |
Rim Halaby (talk | contribs) No edit summary |
||
Line 96: | Line 96: | ||
===Conclusion=== | ===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]].<ref name="circ.ahajournals.org">{{Cite web | last = | first = | title = http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A11851 | url = http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A11851 | publisher = | date = | accessdate = 16 September 2013 }}</ref> | 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]].<ref name="circ.ahajournals.org">{{Cite web | last = | first = | title = http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A11851 | url = http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A11851 | publisher = | date = | accessdate = 16 September 2013 }}</ref> | ||
==References== | ==References== |
Revision as of 21:30, 19 September 2013
High Density Lipoprotein Microchapters |
Diagnosis |
---|
Treatment |
Clinical Trials |
Case Studies |
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers On the Web |
American Roentgen Ray Society Images of A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers |
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 |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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
Objective
- 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.[1]
- Serum pre-Beta-1-HDL elevation was up to 20-fold.[1]
- Serum pre-Beta-1-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]