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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03727802
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : May 14, 2021
Information provided by (Responsible Party):
Toray Industries, Inc

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

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)

Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Up to 7 days after last dose ]

Secondary Outcome Measures :
  1. AUC from time zero to the time of the last quantifiable concentration (AUC0-t last) [ Time Frame: Up to 60 minutes after dose ]
  2. Cmax [ Time Frame: Up to 60 minutes after dose ]
  3. Tmax [ Time Frame: Up to 60 minutes after dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.)

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 identifier (NCT number): NCT03727802

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Contact: TRK-250 team +81-3-3245-8576

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United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Susan Jackman    310-423-1838   
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Chelsea Thompson    916-734-3650   
United States, Florida
Advanced Pulmonary & Sleep Research Institute of Florida Recruiting
Daytona Beach, Florida, United States, 32117
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL Recruiting
Kissimmee, Florida, United States, 34741
Contact: James Yongue       jyongue@PDS-CFSC.Com   
Contact: Emily Fraser Read   
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
United States, North Carolina
PulmonIx LLC Recruiting
Greensboro, North Carolina, United States, 27403
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ron Wehrmann    206-455-0574   
United States, South Carolina
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Rhoda Annoh Gordon    214-645-7108   
Sponsors and Collaborators
Toray Industries, Inc
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Responsible Party: Toray Industries, Inc Identifier: NCT03727802    
Other Study ID Numbers: 250IPF01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

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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:
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases