View source for Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

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{{High density lipoprotein}}

{{CMG}}

==Official Title==
An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics, of Intravenous CSL112 in Healthy Volunteers
==Objective==
* To assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers.
* To measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.
==Sponsor==
CSL Limited
==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%"|June 2010
|-
| '''End Date'''||December 2010
|-
| '''Status'''||Completed
|-
|}
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.</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 (subject, caregiver, investigator, outcomes assessor)
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
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| '''Primary Purpose'''||Treatment
|-
| '''Condition'''||Healthy
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| '''Intervention'''||CSL112 (reconstituted HDL) single escalating intravenous doses
|-
| '''Study Arms'''||Experimental:CSL112 (reconstituted HDL)<br>Placebo comparator:normal saline (0.9%) 
|-
| '''Population Size'''||57
|-
|}

<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.</span>

==Eligibility Criteria==
===Inclusion Criteria===
* Healthy males and females aged 18 years to less than 55 years
* Body weigh 45 kg or greater
===Exclusion Criteria===
* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of clinically relevant abnormal laboratory test result
* Evidence of history of alcohol or substance abuse
==Outcomes==
===Primary Outcomes===
* Safety and tolerability as measured by the frequency and intensity of clinical adverse events
**Time Frame: Up to 14 days after infusion of CSL112
** Designated as safety issue: Yes
* Safety and tolerability as measured by clinical laboratory tests and assessments
** Time Frame: Up to 14 days after infusion of CSL112
** Designated as safety issue: Yes
* Pharmacokinetics of CSL112
** Time Frame: Up to 10 days after infusion of CSL112
** Designated as safety issue: No

===Secondary Outcomes===
* Pharmacokinetic and pharmacodynamic measures of lipid, lipoprotein and related exploratory biomarkers
** Time Frame: Up to 10 days after infusion of CSL112
** Designated as safety issue: No

==Publications==
===Results===

===Conclusion===

==References==
{{Reflist|2}}

{{Lipopedia}}

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