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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
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
80 Years

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
Contact
Jaila Coleman
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05856331
For detailed technical eligibility, visit ClinicalTrials.gov.