Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 1/20/2019 |
| Start Date: | November 28, 2018 |
| End Date: | March 2020 |
| Contact: | TRK-250 team |
| Email: | Clinicaltrials-info@nts.toray.co.jp |
| Phone: | +81-3-3245-8576 |
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).
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).
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.)
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