Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

Exclusion Criteria

• •Known or suspected allergy to components of INBRX-101 (AAT or human IgG) or pdAAT.
• •Participation in any investigational drug trial within 30 days prior to this trial, or subjects receiving IV immunoglobulins or monoclonal antibodies within 30 days prior to this trial.
• •History of and/or on the waiting list for lung or liver transplant, lobectomy, or lung volume reduction surgery.
• •Acute respiratory tract infection or COPD exacerbation that required antibiotic treatment and/or increase in systemic steroid dosage within the 4 weeks prior to screening. Subjects are permitted to continue to receive steroids if the investigator judges the subject to have a history of stable dosing.
• •Subjects with ongoing or history of unstable cor pulmonale.
• •Infection with hepatitis A, B, or C or human immunodeficiency virus (HIV).
• •Active autoimmune disease or documented history of autoimmune disease that 1) required systemic steroids or immune-suppressive medications and 2) tested positive for auto-antibodies. Exception: Endocrinopathies managed with hormone replacement therapy (HRT).
• •Current substance and/or alcohol abuse with protocol defined exceptions.
• •Current narcotics abuse with protocol defined exceptions.