Purpose

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).

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TRK-250
  • Drug: TRK-250
    single and multiple doses (4 weeks)
Placebo Comparator
Placebo
  • Drug: Placebo
    single and multiple doses (4 weeks)

Recruiting Locations

Trials Today and nearby locations

University of Miami Leonard M. Miller School of Medicine (UMMSM) - Sylvester Comprehensive Cancer Center - Miami
Miami, Florida 33136

PulmonIx LLC
Greensboro, North Carolina 27403

Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
Charleston, South Carolina 29425

Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
Kissimmee, Florida 34741

Mayo Clinic
Jacksonville, Florida 32224

Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
Los Angeles, California 90048

Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida 32117

Pulmonary Associates
Phoenix, Arizona 85006

More Details

NCT ID
NCT03727802
Status
Recruiting
Sponsor
Toray Industries, Inc

Study Contact

TRK-250 team
+81-3-3245-8576
Clinicaltrials-info@nts.toray.co.jp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.