NCT01760343

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

Conditions

• Hereditary Angioedema Types I and II

Interventions

Type	Name	Description
BIOLOGICAL	Berinert	Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.
BIOLOGICAL	CSL830	CSL830 is a formulation of Berinert.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-01-04
• Last updated: 2013-04-05

Locations

1 site across 1 country: Germany