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Trial record 1 of 1 for:    INBRX 101
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815396
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE July 19, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • 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.
  • 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.
  • 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.
  • Time to Cmax (Tmax) of INBRX-101 [ Time Frame: Up to 7 months ]
    Time to Cmax (Tmax) of INBRX-101 will be determined.
  • Half-life (T1/2) of INBRX-101 [ Time Frame: Up to 7 months ]
    Half-life of INBRX-101 will be determined.
  • Immunogenicity of INBRX-101 [ Time Frame: Up to 7 months ]
    Frequency and consequences of anti-drug antibodies (ADA) against INBRX-101 will be determined.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alpha-1 Antitrypsin Deficiency
  • AATD
Intervention  ICMJE Drug: INBRX-101/rhAAT-Fc
INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).
Study Arms  ICMJE
  • Experimental: Part 1 Single Ascending Dose
    INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
    Intervention: Drug: INBRX-101/rhAAT-Fc
  • Experimental: Part 2 Multiple Ascending Dose
    INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
    Intervention: Drug: INBRX-101/rhAAT-Fc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Penninga, ClinMgr 858-500-7833 clinicaltrials@inhibrx.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815396
Other Study ID Numbers  ICMJE Ph1 INBRX-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Inhibrx, Inc.
Study Sponsor  ICMJE Inhibrx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Klaus Wagner, MD, PhD CMO
PRS Account Inhibrx, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP