Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT01129661
First received: May 19, 2010
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Healthy
Biological: CSL112 (reconstituted HDL)
Biological: normal saline (0.9%)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by CSL Limited:

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

Secondary Outcome Measures:
  • Pharmacokinetics of lipoprotein. [ Time Frame: Up to 10 days after infusion of CSL112 ] [ Designated as safety issue: No ]
    Plasma levels of lipoprotein.


Enrollment: 57
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT01129661

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

No publications provided

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT01129661     History of Changes
Other Study ID Numbers: CSLCT-HDL-09-63
Study First Received: May 19, 2010
Last Updated: January 20, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on August 19, 2014