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Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727802
Recruitment Status : Completed
First Posted : November 1, 2018
Results First Posted : October 23, 2023
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Description
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Brief Summary:
TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: TRK-250 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TRK-250 Drug: TRK-250
single and multiple doses (4 weeks)
Placebo Comparator: Placebo Drug: Placebo
single and multiple doses (4 weeks)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Adverse Events [ Time Frame: Up to 14 days after last dose ]
    Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical, radiographic, and histologic features consistent with the diagnosis of IPF
  • SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.
  • FVC ≥50% of predicted.
  • FEV1 ≥50% of predicted.
  • Ratio of FEV1 to FVC ≥0.7.
  • DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.

Exclusion Criteria:

  • History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to Screening.
  • Planned surgery during the study.
  • History of malignant tumor within 5 years prior to Screening.
  • History of emphysema or clinically significant respiratory diseases (other than IPF).
  • Other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases).
  • End-stage fibrotic disease expected to require organ transplantation within 6 months.
  • Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening. (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
Contacts and Locations
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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): NCT03727802


Locations
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United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
Los Angeles, California, United States, 90048
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Florida
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, United States, 32117
Mayo Clinic
Jacksonville, Florida, United States, 32224
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
Kissimmee, Florida, United States, 34741
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10021
United States, North Carolina
PulmonIx LLC
Greensboro, North Carolina, United States, 27403
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
Charleston, South Carolina, United States, 29425
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Toray Industries, Inc
  Study Documents (Full-Text)

Documents provided by Toray Industries, Inc:
Study Protocol  [PDF] September 24, 2018
Statistical Analysis Plan  [PDF] June 25, 2019

More Information
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Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03727802    
Other Study ID Numbers: 250IPF01
First Posted: November 1, 2018    Key Record Dates
Results First Posted: October 23, 2023
Last Update Posted: October 23, 2023
Last Verified: June 2022

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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 Toray Industries, Inc:
TRK-250
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases