CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
TRK-250 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03727802
NCT03727802Phase 1Completed
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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

Toray Industries, Inc·interventional·Posted Nov 1, 2018·Updated Oct 23, 2023

In Brief

A Phase 1 clinical trial evaluating TRK-250 and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 34 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 1, 2018
Enrollment StartNov 28, 2018
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.7 years ago

Interventions

TRK-250drug

single and multiple doses (4 weeks)

Placebodrug

single and multiple doses (4 weeks)