Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers: Difference between revisions
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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 | 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 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 | * To measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers. | ||
==Sponsor== | ==Sponsor== | ||
CSL Limited | CSL Limited | ||
Line 39: | Line 39: | ||
| '''Allocation'''||Randomized | | '''Allocation'''||Randomized | ||
|- | |- | ||
| '''Endpoint'''||Safety | | '''Endpoint'''||Safety study | ||
|- | |- | ||
| '''Interventional Model'''||Parallel | | '''Interventional Model'''||Parallel assignment | ||
|- | |- | ||
| '''Masking'''|| Double | | '''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''' | ||
Line 53: | Line 53: | ||
| '''Intervention'''||CSL112 (reconstituted HDL) single escalating intravenous doses | | '''Intervention'''||CSL112 (reconstituted HDL) single escalating intravenous doses | ||
|- | |- | ||
| '''Study Arms'''||Experimental:CSL112 (reconstituted HDL)<br>Placebo | | '''Study Arms'''||Experimental:CSL112 (reconstituted HDL)<br>Placebo comparator:normal saline (0.9%) | ||
|- | |- | ||
| '''Population Size'''||57 | | '''Population Size'''||57 | ||
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===Secondary Outcomes=== | ===Secondary Outcomes=== | ||
Pharmacokinetic and pharmacodynamic measures of lipid, lipoprotein and related exploratory biomarkers | * Pharmacokinetic and pharmacodynamic measures of lipid, lipoprotein and related exploratory biomarkers | ||
** Time Frame: Up to 10 days after infusion of CSL112 | ** Time Frame: Up to 10 days after infusion of CSL112 | ||
** Designated as safety issue: No | ** Designated as safety issue: No | ||
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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