An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

Alpha-1 Antitrypsin Deficiency

The primary PK endpoint is the steady-state AUC of alpha1-PI over the weekly dosing interval (from 0 to 7 days) (AUC0-7 days) in the IV Treatment Period 1 and in the SC Treatment Period 2 for both dose levels.

Steady-state mean trough alpha1-PI levels, following Liquid Alpha1-PI IV and Alpha-1 15% SC administration, determined as follows: • Liquid Alpha1-PI IV administration in Period 1: the average value of the steady-state trough alpha1-PI measurements obtained at Weeks 6, 7, 8, and 9. • Alpha-1 15% SC administration in Period 2: the average value of the steady-state trough alpha1-PI measurements obtained at Weeks 14, 15, 16, and 17., Exploratory Pharmacokinetic Endpoints: The following exploratory PK endpoints will be assessed in this study: • Cmax • tmax • CL for IV and CL/F for SC • t1/2 • Corrected AUC0-7 days, with correction based on the endogenous alpha1-PI concentration measured at Week 20 (4 weeks after the last IP infusion)., Safety Endpoints: The following safety endpoints will be assessed in this study: • Adverse events (AEs), serious adverse events (SAEs), and AEs and SAEs leading to discontinuation • COPD exacerbations • Vital signs (heart rate [HR], blood pressure (BP), respiratory rate [RR], and temperature [T]) • Pulmonary function tests (PFTs)• Clinical laboratory parameters including: • Immunogenicity assessments

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