Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers: Difference between revisions
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==Official Title== | ==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== | ==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== | ==Sponsor== | ||
CSL Limited | |||
==Timeline== | ==Timeline== | ||
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | {| class="wikitable" border="1" style="background:WhiteSmoke" width="40%" | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | ||
|- | |- | ||
| Style="width:30%"| '''Start Date'''||Style="width:70%"| | | Style="width:30%"| '''Start Date'''||Style="width:70%"|June 2010 | ||
|- | |- | ||
| '''End Date'''|| | | '''End Date'''||December 2010 | ||
|- | |- | ||
| '''Status'''|| | | '''Status'''||Completed | ||
|- | |- | ||
|} | |} | ||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number | <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== | ==Study Description== | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | ||
|- | |- | ||
| Style="width:30%"|'''Study Type'''|| Style="width:70%"| | | Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional | ||
|- | |- | ||
| '''Study Phase''' || | | '''Study Phase''' ||Phase 1 | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | ||
|- | |- | ||
| '''Allocation'''|| | | '''Allocation'''||Randomized | ||
|- | |- | ||
| '''Endpoint'''|| | | '''Endpoint'''||Safety study | ||
|- | |- | ||
| '''Interventional Model'''|| | | '''Interventional Model'''||Parallel assignment | ||
|- | |- | ||
| '''Masking'''|| | | '''Masking'''|| Double blind (subject, caregiver, investigator, outcomes assessor) | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | ||
|- | |- | ||
| '''Primary Purpose'''|| | | '''Primary Purpose'''||Treatment | ||
|- | |- | ||
| '''Condition'''|| | | '''Condition'''||Healthy | ||
|- | |- | ||
| '''Intervention'''|| | | '''Intervention'''||CSL112 (reconstituted HDL) single escalating intravenous doses | ||
|- | |- | ||
| '''Study Arms'''|| | | '''Study Arms'''||Experimental:CSL112 (reconstituted HDL)<br>Placebo comparator:normal saline (0.9%) | ||
|- | |- | ||
| '''Population Size'''|| | | '''Population Size'''||57 | ||
|- | |- | ||
|} | |} | ||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number | <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== | ==Eligibility Criteria== | ||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
* Healthy males and females aged 18 years to less than 55 years | |||
* Body weigh 45 kg or greater | |||
===Exclusion Criteria=== | ===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== | ==Outcomes== | ||
===Primary 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=== | ===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== | ==Publications== | ||
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[[Category:HDL]] | [[Category:HDL]] | ||
[[Category:Clinical trials]] | [[Category:Clinical trials]] | ||
[[Category:HDLpedia]] |
Latest revision as of 14:23, 21 October 2013
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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
Timeline | |
Start Date | June 2010 |
End Date | December 2010 |
Status | Completed |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.
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 (subject, caregiver, investigator, outcomes assessor) |
Study Details | |
Primary Purpose | Treatment |
Condition | Healthy |
Intervention | CSL112 (reconstituted HDL) single escalating intravenous doses |
Study Arms | Experimental:CSL112 (reconstituted HDL) Placebo comparator:normal saline (0.9%) |
Population Size | 57 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.
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