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OpenTrials
Completed

NCT Number: NCT01129661

Safety, Tolerability and Pharmacokinetics of 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.

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Key information

Conditions

Healthy

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSL112 (reconstituted HDL)

Biological

Single escalating intravenous doses of CSL112

normal saline (0.9%)

Biological

Single intravenous dose of normal saline (0.9%)

Primary outcomes

  1. Safety and tolerability as measured by the frequency of drug-related clinical adverse events.

    Time frame: Up to 14 days after infusion of CSL112

  2. Safety and tolerability as measured by liver function tests.

    Time frame: Up to 14 days after infusion of CSL112

Secondary outcomes

  1. Pharmacokinetics of lipoprotein.

    Time frame: Up to 10 days after infusion of CSL112

    Plasma levels of lipoprotein.

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 25, 2010
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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