drugset / Trial / NCT01760343
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2013-01
- Primary completion
- 2013-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CINRYZE | Protein / enzyme biologic | 1500 iu | Intravenous |