[Translation] A phase I clinical study evaluating the safety, tolerability and pharmacokinetics of nebulized XYP-001 in healthy adults and patients with idiopathic pulmonary fibrosis
主要研究目的(SAD):评价单次雾化吸入XYP-001后受试者的安全性和耐受性。
次要研究目的(SAD):评价单次雾化吸入XYP-001后受试者的XYP-001及其代谢产物的药代动力学特征。
主要研究目的(MAD):评价多次雾化吸入XYP-001后受试者的安全性和耐受性。
次要研究目的(MAD):评价多次雾化吸入XYP-001后受试者的XYP-001及其代谢产物的药代动力学特征及稳态情况; 评价雾化吸入XYP-001后IPF受试者的XYP-001及其代谢产物的痰液药物峰浓度和谷浓度。
[Translation] Main research purpose (SAD): To evaluate the safety and tolerability of subjects after a single nebulized inhalation of XYP-001.
Secondary research purpose (SAD): To evaluate the pharmacokinetic characteristics of XYP-001 and its metabolites after a single aerosol inhalation of XYP-001.
Main research purpose (MAD): To evaluate the safety and tolerability of subjects after repeated aerosol inhalation of XYP-001.
Secondary research purpose (MAD): To evaluate the pharmacokinetic characteristics and steady state of XYP-001 and its metabolites in subjects after repeated aerosol inhalation of XYP-001; The sputum drug peak and trough concentrations of XYP-001 and its metabolites were tested.