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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2022
  • participants needed
    30
  • sponsor
    Inhibrx, Inc.
Updated on 23 March 2022
renal function
monoclonal antibodies
deficiency
bronchodilator
iv immunoglobulins
bronchoscopy
drug trials
alpha1-proteinase inhibitor (human)

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.

Details
Condition Alpha-1 Antitrypsin Deficiency, AATD
Treatment INBRX-101/rhAAT-Fc
Clinical Study IdentifierNCT03815396
SponsorInhibrx, Inc.
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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