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

Completed · Phase 1 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT03727802

Run by

Toray Industries, Inc

People needed

34

Starts

2018-11-28

Expected to finish

2022-04-01

Last updated by the study team

2023-10-23

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Advanced Pulmonary & Sleep Research Institute of Florida — Daytona Beach, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL — Kissimmee, Florida, United States
• Weill Cornell Medicine — New York, New York, United States
• PulmonIx LLC — Greensboro, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program — Charleston, South Carolina, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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