Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

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

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

• 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
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 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

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

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