drugset / Trial / NCT01095497

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

NCT01095497

Phase 2 Completed 26 enrolled Shire
RandomizedCrossoverOpen-labelOther

Summary

The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration

Timeline

Start
2010-06-07
Primary completion
2010-12-16
Completion
2010-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic Subcutaneous

Indications