[Translation] A single-center, randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the safety and pharmacokinetic characteristics of porselenin tablets combined with standard treatment in patients with fibrotic interstitial lung disease
主要目的:评估标准治疗(由研究者决定)联合卟硒啉片在纤维化性间质性肺病患者中的安全性;
次要目的:评价标准治疗(由研究者决定)联合卟硒啉片在纤维化性间质性肺病患者中的单次和多次给药PK特征;
探索性目的:评价标准治疗(由研究者决定)联合卟硒啉片治疗纤维化性间质性肺病的初步有效性; 探索标准治疗(由研究者决定)联合卟硒啉片治疗纤维化性间质性肺病的生物标志物
[Translation] Primary objective: To evaluate the safety of standard therapy (determined by the investigator) combined with porselenin tablets in patients with fibrotic interstitial lung disease;
Secondary objective: To evaluate the single and multiple dose PK characteristics of standard therapy (determined by the investigator) combined with porselenin tablets in patients with fibrotic interstitial lung disease;
Exploratory objective: To evaluate the preliminary effectiveness of standard therapy (determined by the investigator) combined with porselenin tablets in the treatment of fibrotic interstitial lung disease; To explore the biomarkers of standard therapy (determined by the investigator) combined with porselenin tablets in the treatment of fibrotic interstitial lung disease