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

Toray Industries

Status and phase

Completed

Phase 1

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Placebo

Drug: TRK-250

Study type

Interventional

Funder types

Industry

Identifiers

NCT03727802

250IPF01

Details and patient eligibility

About

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).

Enrollment

34 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.)