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