Dataset from A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following Glassia Therapy in A1PI-Deficient Subjects

The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at a dosage of 60 milligrams per kilogram (mg/kg) Body weight (BW)/week active alpha1-proteinase inhibitor (A1PI) protein for 25 weeks in participants with emphysema due to congenital A1PI deficiency.

本研究的目的分为双重目标：（1）评估GLASSIA经在线过滤后实施静脉注射（intravenous，IV）给药的安全性与潜在免疫原性；（2）针对先天性α1-抗胰蛋白酶（alpha1-proteinase inhibitor，A1PI）缺乏症所致肺气肿的受试者，以每周每千克体重（Body weight，BW）60毫克（mg/kg）的剂量给予活性α1-抗胰蛋白酶（A1PI）蛋白静脉给药，持续25周，以此评估GLASSIA强化治疗对上皮衬液（epithelial lining fluid，ELF）中A1PI水平及多种生物标志物的影响。