A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

March 6, 2012 updated by: CSL Limited

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

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • Q-Pharm

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency of drug-related adverse events
Time Frame: Up to 6 days after each infusion
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
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
up to 6 days after each infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile of apoA-I after multiple intravenous infusions
Time Frame: up to 7 days after each infusion
up to 7 days after each infusion

Collaborators and Investigators

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

Sponsor

CSL Limited

Investigators

  • Study Director: Senior Director, Cardiovascular, 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

January 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • CSLCT-HDL-10-68

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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