A Phase I Study Assessing the Safety, Tolerability, and Pharmacokinetics of Yinfenidone: A Novel, Potent Drug for Idiopathic Pulmonary Fibrosis Treatment in Healthy Chinese Subjects.
Clin TherJun 29, 2026 (epub)
Clinical ResearchPulmonology
Meixian Ou, Yulei Zhuang, Huijuan Zhu et al.
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In 30 seconds
This Phase I randomized controlled trial evaluated the safety, tolerability, and pharmacokinetics of Yinfenidone in healthy Chinese subjects. The study found that Yinfenidone was rapidly absorbed, with a median maximum plasma concentration (T max) of 1.8-3.0 hours and a mean half-life (t 1/2) of 31.9 to 62.0 hours. All adverse events were mild, indicating a favorable safety profile.
Key findings
- Yinfenidone had a median T max of 1.8-3.0 hours and a mean t 1/2 of 31.9 to 62.0 hours.
- Systemic drug exposure increased with dose up to 100 mg, but less than proportionally above that.
- All adverse events were mild, with no serious adverse events reported.
Why it matters
Understanding the pharmacokinetics and safety profile of new treatments like Yinfenidone is crucial for clinicians managing idiopathic pulmonary fibrosis, as it may influence dosing and patient management strategies in future studies.