Clinical Drug Experience Knowledgebase

Criteria

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

Exclusion Criteria:

Clinically significant pulmonary impairment, other than emphysema and/or chronic bronchitis
Clinically significant cardiac, hemostatic, or neurologic impairment, or other significant medical condition that, in the opinion of the investigator, would affect subject safety or compliance
Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
Acute exacerbation of emphysema (as defined in Section 8.5.10) within 28 days prior to randomization
Pregnancy or lactation
Known history of allergy to yeast products
Medical history precluding the use of epinephrine or other rescue medication for treatment of anaphylaxis
Use of antihistamines within 7 days prior to randomization
Use of oral steroids, beta-blockers, or tricyclic antidepressants within 28 days prior to randomization
Use of another investigational drug or investigational device within 28 days prior to randomization
Any upper or lower respiratory infection within 28 days prior to randomization