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

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

Idiopathic Pulmonary Fibrosis

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

Arm	Description	Assigned 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

More Details

NCT ID: NCT03727802
Status: Completed
Sponsor: Toray Industries, Inc

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.