Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
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
1 other identifier
interventional
34
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2018
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
November 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedResults Posted
Study results publicly available
October 23, 2023
CompletedOctober 23, 2023
June 1, 2022
3.3 years
October 24, 2018
December 21, 2022
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Adverse Events
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Up to 14 days after last dose
Study Arms (2)
TRK-250
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
Los Angeles, California, 90048, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, 32117, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
Kissimmee, Florida, 34741, United States
Weill Cornell Medicine
New York, New York, 10021, United States
PulmonIx LLC
Greensboro, North Carolina, 27403, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
Charleston, South Carolina, 29425, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
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.
PMID: 37738329DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Information Desk
- Organization
- Toray Industries, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
November 1, 2018
Study Start
November 28, 2018
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
October 23, 2023
Results First Posted
October 23, 2023
Record last verified: 2022-06