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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebo; Drug: TRK-250

• Registration Number: NCT03727802
• Lead Sponsor: Toray Industries, Inc

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Study Start: 2018-11-28
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Results First Submitted: 2022-12-21
• Results First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Results First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TRK-250	TRK-250	-

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Adverse Events	Up to 14 days after last dose	Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events

Trial Locations

Locations (11)

Advanced Pulmonary & Sleep Research Institute of Florida; 🇺🇸 Daytona Beach, Florida, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute; 🇺🇸 Los Angeles, California, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

PulmonIx LLC; 🇺🇸 Greensboro, North Carolina, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program; 🇺🇸 Charleston, South Carolina, United States

Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL; 🇺🇸 Kissimmee, Florida, United States

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States