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OpenTrials
Completed

NCT Number: NCT03727802

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

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).

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.)

Treatment and study plan

TRK-250

Drug

single and multiple doses (4 weeks)

Placebo

Drug

single and multiple doses (4 weeks)

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Up to 14 days after last dose

    Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study title

TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2018
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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