A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

Exclusion Criteria

• •To be eligible for this protocol, a subject must not:
• •1. Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
• •2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
• •3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
• •4. If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
• •5. Have a history of abnormal blood clotting.
• •6. Have a history of allergic reaction to products containing C1 INH or other blood products.
• •7. Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
• •8. Be pregnant or breastfeeding.
• •9. Have received an investigational study drug within 30 days prior to the first dose of study drug.