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

Inclusion criteria

To be eligible for this protocol, a subject must:

• Have a confirmed diagnosis of HAE.
• During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) treated with C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic acid), IV fluids, or narcotic analgesics.
• Agree to strictly adhere to the protocol-defined schedule of assessments and procedures.

Exclusion criteria

To be eligible for this protocol, a subject must not:

• Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
• Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
• 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.
• 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.
• Have a history of abnormal blood clotting or other coagulopathy.
• Have a history of allergic reaction to CINRYZE or other blood products.
• Be pregnant or breastfeeding.
• Have received an immunization within 30 days prior to the first dose.
• Have participated in any other investigational drug study within 30 days prior to the first dose.