Idiopathic Pulmonary FibrosisPhase 1NCT03727802
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing TRK-250 in people with Idiopathic Pulmonary Fibrosis, run by Toray Industries, Inc at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- TRK-250
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Nov 2018to 1 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, 32117
PulmonIx LLC
Greensboro, North Carolina, 27403
Mayo Clinic
Jacksonville, Florida, 32224
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
Kissimmee, Florida, 34741
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
Los Angeles, California, 90048
Weill Cornell Medicine
New York, New York, 10021
Pulmonary Associates
Phoenix, Arizona, 85006
UC Davis Medical Center
Sacramento, California, 95817
About this study
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
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).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- TRK-250, Placebo
- Keywords
- TRK-250, Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-250Drug
single and multiple doses (4 weeks)
PlaceboDrug
single and multiple doses (4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| TRK-250 | Experimental | Not described Receives: Drug: TRK-250 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Measured: Up to 14 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start28 Nov 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727802
- Sponsor's protocol ID
- 250IPF01
- Status last verified
- Jun 2022
- First submitted
- 24 Oct 2018
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37738329
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03727802
- Acronym / sponsor ID
- 250IPF01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- TRK-250, Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRK-250 | Experimental | Drug: TRK-250 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRK-250single and multiple doses (4 weeks) | Drug | TRK-250 |
| Placebosingle and multiple doses (4 weeks) | Drug | Placebo |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: Up to 14 days after last dose
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37738329Doi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRK-250 in people with Idiopathic Pulmonary Fibrosis, run by Toray Industries, Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: Up to 14 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.