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Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01129661
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : January 24, 2011
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Biological: CSL112 (reconstituted HDL) Biological: normal saline (0.9%) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Primary Completion Date : December 2010
Study Completion Date : January 2011
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: normal saline (0.9%) Biological: normal saline (0.9%)
Single intravenous dose of normal saline (0.9%)
Experimental: CSL112 Biological: CSL112 (reconstituted HDL)
Single escalating intravenous doses of CSL112

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability as measured by the frequency of drug-related clinical adverse events. [ Time Frame: Up to 14 days after infusion of CSL112 ]
  2. Safety and tolerability as measured by liver function tests. [ Time Frame: Up to 14 days after infusion of CSL112 ]

Secondary Outcome Measures :
  1. Pharmacokinetics of lipoprotein. [ Time Frame: Up to 10 days after infusion of CSL112 ]
    Plasma levels of lipoprotein.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

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): NCT01129661

Australia, South Australia
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
CSL Limited
More Information

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT01129661     History of Changes
Other Study ID Numbers: CSLCT-HDL-09-63
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011