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Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Introduction

Official Title

Official 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

Objective

Objective

  • To assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers.
  • To measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.
Sponsor

CSL Limited

Timeline

Timeline

Timeline
Start Date June 2010
End Date December 2010
Status Completed

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.

Study Description

Study Description

Study Description
Study Type Interventional
Study Phase Phase 1
Study Design
Allocation Randomized
Endpoint Safety study
Interventional Model Parallel assignment
Masking Double blind (subject, caregiver, investigator, outcomes assessor)
Study Details
Primary Purpose Treatment
Condition Healthy
Intervention CSL112 (reconstituted HDL) single escalating intravenous doses
Study Arms Experimental:CSL112 (reconstituted HDL)
Placebo comparator:normal saline (0.9%)
Population Size 57

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.

Eligibility Criteria

Eligibility Criteria

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
Outcomes

Outcomes

Primary Outcomes

  • Safety and tolerability as measured by the frequency and intensity of clinical adverse events
    • Time Frame: Up to 14 days after infusion of CSL112
    • Designated as safety issue: Yes
  • Safety and tolerability as measured by clinical laboratory tests and assessments
    • Time Frame: Up to 14 days after infusion of CSL112
    • Designated as safety issue: Yes
  • Pharmacokinetics of CSL112
    • Time Frame: Up to 10 days after infusion of CSL112
    • Designated as safety issue: No

Secondary Outcomes

  • Pharmacokinetic and pharmacodynamic measures of lipid, lipoprotein and related exploratory biomarkers
    • Time Frame: Up to 10 days after infusion of CSL112
    • Designated as safety issue: No
Publications

Publications

Results

Conclusion

References

References

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]