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