Status:
COMPLETED
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
Lead Sponsor:
Inhibrx Biosciences, Inc
Conditions:
Alpha-1 Antitrypsin Deficiency
AATD
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 multipl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03815396
Start Date
July 19 2019
End Date
August 18 2022
Last Update
September 13 2022
Active Locations (10)
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1
UC Davis School of Medicine
Sacramento, California, United States, 95817
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32611
3
University of Miami
Miami, Florida, United States, 33125
4
Indiana University
Indianapolis, Indiana, United States, 46202