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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727802
• Other study ID #: 250IPF01
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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