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

Purpose

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

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
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.)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TRK-250
  • Drug: TRK-250
    single and multiple doses (4 weeks)
Placebo Comparator
Placebo
  • Drug: Placebo
    single and multiple doses (4 weeks)

Recruiting Locations

More Details

NCT ID
NCT03727802
Status
Completed
Sponsor
Toray Industries, Inc

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center