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Actively Recruiting
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
About
Brief Summary
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Males or females 18-80 years of age, inclusive, at the time of screening
- Diagnosis of AATD
- Evidence of emphysema secondary to AATD
- FEV1 of ≥ 30% and ≤ 80% predicted at screening
- Current non-smoking status.
Exclusion Criteria:
- Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
- Known or suspected allergy to components of INBRX-101, A1PI or human IgG
- Known selective or severe Immunoglobulin A (IgA) deficiency
- Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
- On waiting list for lung or liver transplant
- Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
- Evidence of decompensated cirrhosis
- Active cancers or has a history of malignancy within 5 years prior to screening
- History of unstable cor pulmonale
- Clinically significant congestive heart failure
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Study Stats
Protocol No.
23-001162
Category
Genetic and Rare Diseases
Lung/Respiratory Disorders
Principal Investigator
Contact
Location
- UCLA Westwood