Clinical trial NCT03727802: Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: TRK-250
Idiopathic Pulmonary Fibrosis
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.)

Primary outcomes:
measure: Incidence and Severity of Adverse Events
timeFrame: Up to 14 days after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Daytona Beach
country: United States
facility: Advanced Pulmonary & Sleep Research Institute of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
state: Florida
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Greensboro
country: United States
facility: PulmonIx LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
state: South Carolina
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: