Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

January 20, 2011 updated by: CSL Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • CMAX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of lipoprotein.
Time Frame: Up to 10 days after infusion of CSL112
Plasma levels of lipoprotein.
Up to 10 days after infusion of CSL112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (ESTIMATE)

May 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • CSLCT-HDL-09-63

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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