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

Summary

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).

Timeline

Start

2018-11-28

Primary completion

2022-04-01

Completion

2022-04-01

Publications

• Doi H, Atsumi J, Baratz D, Miyamoto Y. A Phase I Study of TRK-250, a Novel siRNA-Based Oligonucleotide, in Patients with Idiopathic Pulmonary Fibrosis. J Aerosol Med Pulm Drug Deliv. 2023 Dec;36(6):300-308. doi: 10.1089/jamp.2023.0014. Epub 2023 Sep 22.

Drugs

Indications