Find trials
Consejos para buscar

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

Overview

Información sobre este estudio

The purpose of this study is to assess the safety and tolerability of single- and multiple-inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Sadia Shah, M.D., M.B.A.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

.
CLS-20461634

Mayo Clinic Footer