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

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


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).

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


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.)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note