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A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01281774
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
CSL Limited

Brief Summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Condition or disease Intervention/treatment Phase
Healthy Biological: CSL112 Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Adaptive, Phase I, Randomised, Placebo-controlled, Sponsor-unblinded, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous CSL112 in Healthy Volunteers
Study Start Date : January 2011
Primary Completion Date : June 2011
Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: CSL112
Multiple ascending intravenous doses of CSL112
Biological: CSL112
reconstituted high density lipoprotein
Placebo Comparator: Placebo
Multiple intravenous infusions of placebo
Biological: Placebo
Normal saline (0.9%)



Primary Outcome Measures :
  1. The frequency of drug-related adverse events [ Time Frame: Up to 6 days after each infusion ]
  2. The frequency of redness and swelling at the infusion site [ Time Frame: up to 24 hours after each infusion ]
  3. Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) [ Time Frame: up to 6 days after each infusion ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile of apoA-I after multiple intravenous infusions [ Time Frame: up to 7 days after each infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females aged 18 years to less than 55 years
  • Body weight 50kg or greater
  • Body mass index (BMI) between 18 and 42.0 kg/m2

Exclusion Criteria:

  • Evidence of a clinically significant medical condition, disorder or disease
  • Evidence of hepatobiliary disease
  • Any clinically relevant abnormal laboratory test result
  • Evidence or history of alcohol or substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281774


Locations
Australia, Queensland
Q-Pharm
Brisbane, Queensland, Australia, 4006
Sponsors and Collaborators
CSL Limited
Investigators
Study Director: Senior Director, Cardiovascular CSL Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01281774     History of Changes
Other Study ID Numbers: CSLCT-HDL-10-68
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012