Phase 1 Interstitial Lung Disease Trial, Completed NCT03727802 Sponsor: Toray Industries, Inc Condition: Interstitial Lung Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03727802) tested a medicine called TRK-250 across two parts (Part A and Part B). In Part A, small groups of three to four participants each received one of four different doses of TRK-250 (2 mg, 10 mg, 30 mg, or 60 mg), while four participants received a placebo (a dummy treatment with no active ingredient). In Part B, groups of four participants received one of three doses of TRK-250 (10 mg, 30 mg, or 60 mg), and six participants received a placebo. In total, 34 people started the trial, and 32 completed it — one person in the Part B 60 mg group and one in the Part B placebo group did not finish. The primary outcome — meaning the main thing the trial set out to measure — was the number of participants who experienced adverse events (unwanted or unexpected health occurrences) and how severe those were. The reported data shows that in Part A, 1 participant in the 2 mg group, 0 in the 10 mg group, 3 in the 30 mg group, 2 in the 60 mg group, and 1 in the placebo group reported adverse events. In Part B, 3 participants in the 10 mg group, 2 in the 30 mg group, 3 in the 60 mg group, and 3 in the placebo group reported adverse events. Some severity-level figures were partially reported (for example, 2 participants in the Part A 30 mg group were noted at a particular severity level), but the remaining severity breakdown data was not fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 1 Interstitial Lung Disease Trial, Completed

NCT03727802
Completed Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with IPF (idiopathic pulmonary fibrosis) based on clinical assessment, imaging, and tissue analysis.
  • Your blood oxygen level is 90% or higher when measured at rest while breathing normal air.
  • Your lung capacity (the amount of air you can breathe in) is at least 50% of what is expected for someone of your age and size.
  • The amount of air you can forcefully breathe out in one second is at least 50% of what is expected for someone of your age and size.
  • The ratio of air breathed out quickly to your total lung capacity meets a certain threshold (confirm with trial site).
  • Your lungs' ability to transfer oxygen into the blood falls within a specific range — between 30% and 79% of the expected level.

Who may not be able to join:

  • You have had a sudden worsening of your IPF or a respiratory infection in the past 3 months.
  • You have surgery planned during the period of the study.
  • You have been diagnosed with cancer within the past 5 years.
  • You have emphysema or another significant lung or breathing condition besides IPF.
  • Your lung disease is known to be caused by something other than IPF, such as a medication, environmental exposure, or another illness affecting the immune system.
  • Your lung disease is so advanced that doctors expect you may need a lung transplant within the next 6 months.
  • You have taken certain medications — including steroids, chemotherapy-type drugs, or treatments for high blood pressure in the lungs — within the past 4 weeks (note: the IPF medications pirfenidone or nintedanib may be allowed if you have been on a stable dose for at least 4 weeks and the dose is not expected to change — confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 1
Sponsor
Toray Industries, Inc
Registry
ClinicalTrials.gov
Start date
28 November 2018
Est. completion
1 April 2022

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and Severity of Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov