Toray Study

Condition: Idiopathic pulmonary fibrosis

Eligibility

Key Inclusion Criteria

  • Between 40 and 80 years old
  • Women of childbearing potential and all male participants must agree to use contraception
  • Features consistent with idiopathic pulmonary fibrosis (IPF) within 5 years prior to screening

Key Exclusion Criteria

  • Serious or uncontrolled medical, surgical or psychiatric disease that would compromise the participant’s safety
  • History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to screening
  • Planned surgery during the study 

Full Study Name

TRK-250 – A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis (IRB no. 54371)

Summary
The purpose of this study is to evaluate the safety and tolerability of an experimental drug called TRK-250 after single and multiple inhaled doses in patients with idiopathic pulmonary fibrosis (IPF). TRK-250 is intended to inhibit the messages in the cell that create a protein involved in lung fibrosis (scarring). This study will be conducted in two parts, single inhaled dose (Part A) and multiple inhaled doses (Part B). Subjects in both parts will be randomly assigned to receive either TRK-250 or placebo (inactive substance). 

Principal Investigator

Jeremy Falk, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org