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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRK-250
Placebo
Sponsored by
Toray Industries, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring TRK-250, Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Pulmonary Associates
  • Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
  • UC Davis Medical Center
  • Advanced Pulmonary & Sleep Research Institute of Florida
  • Mayo Clinic
  • Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
  • Weill Cornell Medicine
  • PulmonIx LLC
  • Cleveland Clinic
  • Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
  • The University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRK-250

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence and Severity of Adverse Events
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events

Secondary Outcome Measures

Full Information

First Posted
October 24, 2018
Last Updated
December 21, 2022
Sponsor
Toray Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03727802
Brief Title
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
TRK-250, Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRK-250
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRK-250
Intervention Description
single and multiple doses (4 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single and multiple doses (4 weeks)
Primary Outcome Measure Information:
Title
Incidence and Severity of Adverse Events
Description
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Time Frame
Up to 14 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Advanced Pulmonary & Sleep Research Institute of Florida
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
PulmonIx LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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