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
  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 April 21, 2014