NCT01281774

A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CSL Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CSL112	reconstituted high density lipoprotein
BIOLOGICAL	Placebo	Normal saline (0.9%)

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-01-24
• Last updated: 2012-03-07

Locations

1 site across 1 country: Australia