A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers: Difference between revisions
Rim Halaby (talk | contribs) |
Rim Halaby (talk | contribs) No edit summary |
||
Line 13: | Line 13: | ||
===Start Date=== | ===Start Date=== | ||
June 2010 | June 2010 | ||
===Final Data Collection for Primary Outcomes End Date=== | |||
December 2010 | December 2010 | ||
Line 33: | Line 33: | ||
*2 study arms: Intravenous placebo infusions composed of 0.9% normal saline and single escalating intravenous doses of CSL112 composed of reconstituted HDL. | *2 study arms: Intravenous placebo infusions composed of 0.9% normal saline and single escalating intravenous doses of CSL112 composed of reconstituted HDL. | ||
*There | *There are 3 dosing groups: 4 once-weekly infusions of 3.4 g, 4 once-weekly infusions of 6.8 g, and 8 twice-weekly infusions of 3.4 g | ||
*Biomarkers of cholesterol movement - cholesterol efflux capacity, serum preBeta1-HDL and HDL were measured. | *Biomarkers of cholesterol movement - cholesterol efflux capacity, serum preBeta1-HDL and HDL were measured. | ||
==Outcomes== | ==Outcomes== | ||
* | *Primary Outcomes: Safety and tolerability defined as rate of clinically associated adverse events that occur within 14 days of CSL112 infusion. | ||
*Secondary Outcomes: Evaluation of lipoprotein pharmacokinetics during a time frame of 10 days following CSL112 infusion and measurement of plasma levels of lipoprotein. | |||
==Results== | |||
* Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers. | * Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers. |
Revision as of 01:13, 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]
Objective
- To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.
- To evaluate role of CSL-112 in decreasing cholesterol-loaded plaques that contribute to cardiovascular disease.
Timeline
Start Date
June 2010
Final Data Collection for Primary Outcomes End Date
December 2010
Study Completion Date
January 2011
Methods
- 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.
- There are 3 dosing groups: 4 once-weekly infusions of 3.4 g, 4 once-weekly infusions of 6.8 g, and 8 twice-weekly infusions of 3.4 g
- Biomarkers of cholesterol movement - cholesterol efflux capacity, serum preBeta1-HDL and HDL were measured.
Outcomes
- Primary Outcomes: Safety and tolerability defined as rate of clinically associated adverse events that occur within 14 days of CSL112 infusion.
- Secondary Outcomes: Evaluation of lipoprotein pharmacokinetics during a time frame of 10 days following CSL112 infusion and measurement of plasma levels of lipoprotein.
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.[1]
References
- ↑ "http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A11851". Retrieved 16 September 2013. External link in
|title=
(help)