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

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ClinicalTrials.gov Identifier: NCT03815396
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

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 multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.

Condition or disease Intervention/treatment Phase
Alpha-1 Antitrypsin Deficiency AATD Drug: INBRX-101/rhAAT-Fc Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Part 1 Single Ascending Dose
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
Drug: INBRX-101/rhAAT-Fc
INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).

Experimental: Part 2 Multiple Ascending Dose
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
Drug: INBRX-101/rhAAT-Fc
INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).




Primary Outcome Measures :
  1. Frequency of adverse events of INBRX-101 [ Time Frame: Up to 7 months ]
    Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.

  2. Severity of adverse events of INBRX-101 [ Time Frame: Up to 7 months ]
    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.


Secondary Outcome Measures :
  1. Area under the serum concentration time curve (AUC) of INBRX-101 [ Time Frame: Up to 7 months ]
    Area under the serum concentration time curve (AUC) of INBRX-101 will be determined.

  2. Maximum observed serum concentration (Cmax) of INBRX-101 [ Time Frame: Up to 7 months ]
    Maximum observed serum concentration (Cmax) of INBRX-101 will be determined.

  3. Trough observed serum concentration (Ctrough) of INBRX-101 [ Time Frame: Up to 7 months ]
    Trough observed serum concentration (Cmax) of INBRX-101 will be determined.

  4. Time to Cmax (Tmax) of INBRX-101 [ Time Frame: Up to 7 months ]
    Time to Cmax (Tmax) of INBRX-101 will be determined.

  5. Half-life (T1/2) of INBRX-101 [ Time Frame: Up to 7 months ]
    Half-life of INBRX-101 will be determined.

  6. Immunogenicity of INBRX-101 [ Time Frame: Up to 7 months ]
    Frequency and consequences of anti-drug antibodies (ADA) against INBRX-101 will be determined.

  7. Distribution of INBRX-101 in Bronchoalveolar Lavage Fluid (BALF) [ Time Frame: Up to 7 months ]
    The concentration of INBRX-101 in bronchoalveolar lavage fluid (BALF) be determined.

  8. Functional concentration of INBRX-101 in serum and BALF [ Time Frame: Up to 7 months ]
    The functional concentration of INBRX-101 in serum and BALF will be determined.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Post-bronchodilator FEV1 of at least 40% of predicted normal value.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815396


Contacts
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Contact: Kirsti Cook, VPClinOps 949-264-3862 clinicaltrials@inhibrx.com
Contact: Rebecca Penninga, ClinMgr 949-264-3862 clinicaltrials@inhibrx.com

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Stephanie Fritz    317-274-4363    safritz@iu.edu   
Principal Investigator: Cynthia Brown, MD         
Sponsors and Collaborators
Inhibrx, Inc.
Investigators
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Study Director: Klaus Wagner, MD, PhD CMO

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Responsible Party: Inhibrx, Inc.
ClinicalTrials.gov Identifier: NCT03815396     History of Changes
Other Study ID Numbers: Ph1 INBRX-101
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inhibrx, Inc.:
Alpha-1 antitrypsin deficiency
AATD
alpha-1 disease
AAT

Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action