A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
NCT ID: NCT01281774
Last Updated: 2012-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2011-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CSL112
Multiple ascending intravenous doses of CSL112
CSL112
reconstituted high density lipoprotein
Placebo
Multiple intravenous infusions of placebo
Placebo
Normal saline (0.9%)
Interventions
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CSL112
reconstituted high density lipoprotein
Placebo
Normal saline (0.9%)
Eligibility Criteria
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Inclusion Criteria
* Body weight 50kg or greater
* Body mass index (BMI) between 18 and 42.0 kg/m2
Exclusion Criteria
* Evidence of hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Evidence or history of alcohol or substance abuse
18 Years
55 Years
ALL
Yes
Sponsors
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CSL Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Director, Cardiovascular
Role: STUDY_DIRECTOR
CSL Limited
Locations
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Q-Pharm
Brisbane, Queensland, Australia
Countries
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References
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Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
Easton R, Gille A, D'Andrea D, Davis R, Wright SD, Shear C. A multiple ascending dose study of CSL112, an infused formulation of ApoA-I. J Clin Pharmacol. 2014 Mar;54(3):301-10. doi: 10.1002/jcph.194. Epub 2013 Oct 22.
Other Identifiers
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CSLCT-HDL-10-68
Identifier Type: -
Identifier Source: org_study_id
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