A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers: Difference between revisions
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==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== | ==Objective== | ||
*To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.<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> | *To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.<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> | ||
*To evaluate role of CSL-112 in decreasing cholesterol-loaded plaques that contribute to cardiovascular disease.<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> | *To evaluate role of CSL-112 in decreasing cholesterol-loaded plaques that contribute to cardiovascular disease.<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> | ||
==Sponsor== | |||
CSL Limited | |||
==Timeline== | ==Timeline== | ||
=== | {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | ||
|- | |||
=== | | Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | ||
|- | |||
| Style="width:30%"| '''Start Date'''||Style="width:70%"| January 2011 | |||
= | |- | ||
| '''End Date'''||June 2011 | |||
|- | |||
| '''Status'''||Completed | |||
= | |- | ||
|} | |||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01281774.</span> | |||
==Study Description== | |||
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | |||
|- | |||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | |||
|- | |||
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional | |||
|- | |||
| '''Study Phase''' ||Phase 1 | |||
|- | |||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | |||
|- | |||
| '''Allocation'''||Randomized | |||
|- | |||
| '''Endpoint'''||Safety Study | |||
|- | |||
| '''Interventional Model'''||Parallel Assignment | |||
|- | |||
| '''Masking'''||Double Blind | |||
|- | |||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | |||
|- | |||
| '''Primary Purpose'''||Treatment | |||
|- | |||
| '''Condition'''||Healthy | |||
|- | |||
| '''Intervention'''||Biological: CSL112 (reconstituted high density lipoprotein)<br>Biological: Placebo (normal saline) | |||
|- | |||
| '''Study Arms'''||Multiple ascending intravenous doses of CSL112<br>Placebo | |||
|- | |||
| '''Population Size'''||36 | |||
|- | |||
|} | |||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01281774.</span> | |||
==Eligibility Criteria== | |||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
*Healthy individual | *Healthy individual | ||
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*History of alcohol or other substance abuse | *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.<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> | Safety and tolerability defined as rate of clinically-associated [[adverse events]] that occur within 14 days of CSL112 infusion.<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> | ||
===Secondary Outcomes=== | |||
Evaluation of [[lipoprotein]] [[pharmacokinetics]] during a time frame of 10 days following CSL112 infusion and measurement of plasma levels of [[lipoprotein]].<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> | Evaluation of [[lipoprotein]] [[pharmacokinetics]] during a time frame of 10 days following CSL112 infusion and measurement of plasma levels of [[lipoprotein]].<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> | ||
==Publications== | |||
==Results== | ===Results=== | ||
* Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers.<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> | * Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers.<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> | ||
Line 64: | Line 94: | ||
* There were no observed changes in the baseline of other lipoproteins.<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> | * There were no observed changes in the baseline of other lipoproteins.<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> | ||
==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 21:21, 19 September 2013
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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]