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

  • STATUS
    Recruiting
  • End date
    Apr 23, 2022
  • participants needed
    34
  • sponsor
    Toray Industries, Inc
Updated on 23 May 2021
idiopathic pulmonary fibrosis
diffusion capacity of the lung for carbon monoxide

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-1) 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).

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Placebo, TRK-250
Clinical Study IdentifierNCT03727802
SponsorToray Industries, Inc
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

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.)
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