NCT01129661

Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: CSL Limited · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CSL112 (reconstituted HDL)	Single escalating intravenous doses of CSL112
BIOLOGICAL	normal saline (0.9%)	Single intravenous dose of normal saline (0.9%)

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-05-25
• Last updated: 2011-01-24

Locations

1 site across 1 country: Australia