[Translation] A randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of oral INS018_055 in subjects with idiopathic pulmonary fibrosis (IPF)
主要目的: 评价与安慰剂相比,成人IPF受试者口服INS018_055长达12周的安全性和耐受性。
次要目的
评价IPF受试者口服INS018_055后的药代动力学 (PK)
评价与安慰剂相比,成人IPF受试者口服INS018_055长达12周在FVC下降方面的有效性
评价与安慰剂相比,口服INS018_055治疗长达12周在改善生活质量(QoL)和功能指标方面的有效性 评价与安慰剂相比,INS018_055口服给药对IPF急性加重的影响
探索性目的为:
● 探索口服INS018_055对血液中IPF疾病相关的生物标志物的影响
● 用高通量蛋白组学探索INS018_055在IPF病人血液蛋白质组中的潜在作用机制
[Translation] Primary objective: To evaluate the safety and tolerability of oral INS018_055 for up to 12 weeks in adult IPF subjects compared with placebo.
Secondary objectives
To evaluate the pharmacokinetics (PK) of INS018_055 after oral administration in IPF subjects
To evaluate the effectiveness of oral INS018_055 for up to 12 weeks in adult IPF subjects compared with placebo in terms of FVC decline
To evaluate the effectiveness of oral INS018_055 treatment for up to 12 weeks compared with placebo in improving quality of life (QoL) and functional indicators To evaluate the effect of oral administration of INS018_055 on acute exacerbations of IPF compared with placebo
Exploratory objectives are:
● To explore the effect of oral INS018_055 on IPF disease-related biomarkers in the blood
● To explore the potential mechanism of action of INS018_055 in the blood proteome of IPF patients using high-throughput proteomics