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Completed

NCT Number: NCT01281774

A Multiple Ascending Dose Study of 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm

Brisbane, Queensland, 4006, 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 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

Treatment and study plan

CSL112

Biological

reconstituted high density lipoprotein

Placebo

Biological

Normal saline (0.9%)

Primary outcomes

  1. The frequency of drug-related adverse events

    Time frame: Up to 6 days after each infusion

  2. The frequency of redness and swelling at the infusion site

    Time frame: up to 24 hours after each infusion

  3. Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

    Time frame: up to 6 days after each infusion

Secondary outcomes

  1. Pharmacokinetic profile of apoA-I after multiple intravenous infusions

    Time frame: up to 7 days after each infusion

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2011
Registry last updated
Mar 7, 2012

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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