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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03727802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Toray Industries, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program

Charleston, South Carolina, 29425

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

PulmonIx LLC, Greensboro, North Carolina

Status

Recruiting

Address

PulmonIx LLC

Greensboro, North Carolina, 27403

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10021

Miami, Florida

Status

Recruiting

Address

University of Miami Leonard M. Miller School of Medicine (UMMSM) - Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136

Kissimmee, Florida

Status

Recruiting

Address

Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL

Kissimmee, Florida, 34741

Mayo Clinic, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic

Jacksonville, Florida, 32224

Daytona Beach, Florida

Status

Recruiting

Address

Advanced Pulmonary & Sleep Research Institute of Florida

Daytona Beach, Florida, 32117

Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute

Los Angeles, California, 90048

Pulmonary Associates, Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates

Phoenix, Arizona, 85006

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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