A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

Overview

About this study

The purpose of this study is to assess the safety and tolerability of single- and multiple-inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Tarik Haddad, M.D.

Open for enrollment

Contact information:

Laura Akhtar CCRP

127or7839648

Akhtar.Laura@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461634

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