Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency

Inclusion Criteria

• •Male or female 18 years of age or older
• •Endogenous plasma AAT levels \< 11 µM (\< 80 mg/dL)
• •Baseline forced expiratory volume at one second (FEV1) that is \>= 50% of predicted, measured 30 minutes after a short-acting inhaled bronchodilator
• •Baseline arterial oxygen percent saturation (SaO2) within the normal limits for the individual study site
• •For subjects receiving an inhaled corticosteroid, β-2 agonist (eg, albuterol via metered dose inhaler \[MDI\]) or anticholinergic bronchodilator (eg, ipratropium bromide), treatment on a stable dose for at least 14 days prior to randomization
• •If female of childbearing potential, negative urine pregnancy test within 3 days prior to randomization and agreement to employ adequate birth control measures
• •No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed no more than 7 days prior to randomization
• •Baseline laboratory results, obtained no more than 7 days prior to randomization, meeting the following criteria:
• •Serum aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2 times upper limit of normal range (ULN)
• •Serum total bilirubin \<= 2 times ULN
• •\< 2+ proteinuria on urine dipstick
• •Serum creatinine \<= 1.5 times ULN
• •Absolute neutrophil count \>= 1500 cells/mm3
• •Hemoglobin \>= 10.0 g/dL
• •Platelet count \>= 100,000/mm3
• •Signed informed consent