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A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01281774
First received: January 21, 2011
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • The frequency of redness and swelling at the infusion site [ Time Frame: up to 24 hours after each infusion ] [ Designated as safety issue: Yes ]
  • Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) [ Time Frame: up to 6 days after each infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of apoA-I after multiple intravenous infusions [ Time Frame: up to 7 days after each infusion ] [ Designated as safety issue: No ]

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%)

  Eligibility

Ages Eligible for Study:   18 Years to 55 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281774

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

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01281774     History of Changes
Other Study ID Numbers: CSLCT-HDL-10-68
Study First Received: January 21, 2011
Last Updated: March 6, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on May 19, 2013