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A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
CSL Limited Identifier:
First received: January 21, 2011
Last updated: March 6, 2012
Last verified: March 2012
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Condition Intervention Phase
Healthy Biological: CSL112 Biological: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by CSL Limited:

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

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

Enrollment: 36
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)


Ages Eligible for Study:   18 Years to 55 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01281774

Australia, Queensland
Brisbane, Queensland, Australia, 4006
Sponsors and Collaborators
CSL Limited
Study Director: Senior Director, Cardiovascular CSL Limited
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CSL Limited Identifier: NCT01281774     History of Changes
Other Study ID Numbers: CSLCT-HDL-10-68
Study First Received: January 21, 2011
Last Updated: March 6, 2012 processed this record on August 17, 2017