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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 1, 2022

Interventions

  • Drug: TRK-250
    • single and multiple doses (4 weeks)
  • Drug: Placebo
    • single and multiple doses (4 weeks)

Arms, Groups and Cohorts

  • Experimental: TRK-250
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Toray Industries, Inc
  • Provider of Information About this Clinical Study
    • Sponsor

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