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

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

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).

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: TRK-250; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Pulmonary Associates
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Advanced Pulmonary & Sleep Research Institute of Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Kissimmee, Florida, United States, 34741
      • Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • PulmonIx LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; single and multiple doses (4 weeks)
Experimental: TRK-250	Drug: TRK-250; single and multiple doses (4 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Adverse Events	Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events	Up to 14 days after last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)	Up to 60 minutes after dose
Cmax	Up to 60 minutes after dose
Tmax	Up to 60 minutes after dose

Collaborators and Investigators

• Sponsor: Toray Industries, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis; TRK-250
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 250IPF01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No