Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients 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).
- Idiopathic Pulmonary Fibrosis
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.)
- Phase 1
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Greensboro, North Carolina 27403
Cleveland, Ohio 44195
Charleston, South Carolina 29425
New York, New York 10021
Kissimmee, Florida 34741
Los Angeles, California 90048
Daytona Beach, Florida 32117
Jacksonville, Florida 32224
Phoenix, Arizona 85006
- NCT ID
- Toray Industries, Inc
Study ContactTRK-250 team