Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Brooks Kuhn, MD

Description

Summary

This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.

Official Title

An Open-Label, Multicenter, Phase 1 Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of Inhibrx rhAAT-Fc (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD)

Keywords

Alpha-1 Antitrypsin Deficiency AATD alpha-1 disease AAT Alpha 1-Antitrypsin Deficiency INBRX-101/rhAAT-Fc

Eligibility

You can join if…

Open to people ages 18-80

  • Documented alpha-1 antitrypsin (AAT) serum concentration <11 μM.
  • Diagnosis of alpha-1 antitrypsin deficiency (AATD) with any allelic combination with exception of the null/null genotype.
  • For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: post-bronchodilator FEV1 of at least 40% of predicted normal value.
  • For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: subjects eligible for bronchoscopy per judgment of investigator.
  • Nonsmoker for at least 6 months prior to study and must remain nonsmoking for the entire study duration.
  • Adequate hepatic and renal function as defined per protocol.
  • Willing to undergo current augmentation therapy washout (if applicable) and refrain from initiating augmentation therapy, other investigational drug trials for AATD, therapy with IV immunoglobulins or monoclonal antibodies during the entire study, including follow-up.

You CAN'T join if...

  • 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.

Locations

  • UC Davis School of Medicine accepting new patients
    Sacramento California 95817 United States
  • Hannibal Clinic accepting new patients
    Hannibal Missouri 63401 United States

Lead Scientist at UC Davis

  • Brooks Kuhn, MD
    Assistant Professor, Pulmonary, Critical Care, and Sleep Medicine. Authored (or co-authored) 19 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Inhibrx, Inc.
Links
Sign up for this study
ID
NCT03815396
Phase
Phase 1
Study Type
Interventional
Last Updated