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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03815396
Other study ID # Ph1 INBRX-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 19, 2019
Est. completion date August 18, 2022

Study information

Verified date September 2022
Source Inhibrx, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 18, 2022
Est. primary completion date August 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
INBRX-101/rhAAT-Fc
INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).

Locations

Country Name City State
New Zealand The New Zealand Respiratory and Sleep Institute Auckland
New Zealand Christchurch Clinical Studies Trust Ltd Christchurch
New Zealand Waikato Respiratory and Gastro Research Unit Hamilton
United Kingdom University Hospital Birmingham NHS Foundation Trust Birmingham West Midlands
United Kingdom University of Cambridge Cambridge East Of England
United States University of Florida College of Medicine Gainesville Florida
United States Hannibal Clinic Hannibal Missouri
United States Indiana University Indianapolis Indiana
United States University of Miami Miami Florida
United States UC Davis School of Medicine Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Inhibrx, Inc.

Countries where clinical trial is conducted

United States,  New Zealand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of adverse events of INBRX-101 Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Up to 7 months
Primary Severity of adverse events of INBRX-101 Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Up to 7 months
Secondary Area under the serum concentration time curve (AUC) of INBRX-101 Area under the serum concentration time curve (AUC) of INBRX-101 will be determined. Up to 7 months
Secondary Maximum observed serum concentration (Cmax) of INBRX-101 Maximum observed serum concentration (Cmax) of INBRX-101 will be determined. Up to 7 months
Secondary Trough observed serum concentration (Ctrough) of INBRX-101 Trough observed serum concentration (Cmax) of INBRX-101 will be determined. Up to 7 months
Secondary Time to Cmax (Tmax) of INBRX-101 Time to Cmax (Tmax) of INBRX-101 will be determined. Up to 7 months
Secondary Half-life (T1/2) of INBRX-101 Half-life of INBRX-101 will be determined. Up to 7 months
Secondary Immunogenicity of INBRX-101 Frequency and consequences of anti-drug antibodies (ADA) against INBRX-101 will be determined. Up to 7 months
Secondary Distribution of INBRX-101 in Bronchoalveolar Lavage Fluid (BALF) The concentration of INBRX-101 in bronchoalveolar lavage fluid (BALF) be determined. Up to 7 months
Secondary Functional concentration of INBRX-101 in serum and BALF The functional concentration of INBRX-101 in serum and BALF will be determined. Up to 7 months
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