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

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.)