Phase 1
Completed N=34
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov NCT03727802 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Oct 2023
Primary outcomePrimary: Incidence and Severity of Adverse Events — 1; 0; 3; 2 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events |
1; 0; 3; 2; 1; 3 | — |
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.)
Data sourced from ClinicalTrials.gov (NCT03727802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.