Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

Inclusion Criteria: The subject or subject´s legally authorized representative has provided written informed consent Subject is 18 years of age or older Subject has a documented, endogenous plasma Alpha1-PI level < 8 Micromolar Subject is of the genotype Pi*Z/Z, Pi*Z/Null, Pi*Null/Null, Pi*Malton/Z, or others, dependent on the approval by the Sponsor If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study Laboratory results obtained at the screening visit, meeting the following criteria: Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2 times the upper limit of normal (ULN) Serum total bilirubin <= 2 times ULN Proteinuria < +2 on dipstick analysis Serum creatinine <= 1.5 times ULN Absolute neutrophil count (ANC) >= 1500 cells/mm3 Hemoglobin >= 10.0 g/dL Platelet count >= 10^5/mm3 If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration Nonsmoker for a minimum of 3 months prior to first study product administration Exclusion Criteria: The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level < 15 mg/dL) and/or antibody to IgA The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration The subject is pregnant or lactating, or intends to become pregnant during the course of the study The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance