[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and food effects of UA026 tablets in healthy adult subjects and adult patients with moderate to severe plaque psoriasis
主要目的:
评估在健康成年受试者中单次和多次口服UA026片后的安全性和耐受性;
评估在中、重度银屑病成年患者中口服UA026片后的安全性及耐受性。
次要目的:
评估在健康成年受试者中单次和多次口服UA026片后的药代动力学特征;
评估在中、重度银屑病成年患者中口服UA026片后的药代动力学特征;
评估健康成年受试者在空腹和餐后单次服用UA026片后食物对药物的药代动力学的影响;
评估UA026在中、重度银屑病成年患者中的初步疗效;
评估UA026在健康成年受试者和中、重度银屑病成年患者中的药效学生物标志物的变化。
探索性目的:
探索在健康成年受试者中口服UA026片后的QT/QTc间期变化。
[Translation] Primary objectives:
To evaluate the safety and tolerability of UA026 tablets after single and multiple oral administration in healthy adult subjects;
To evaluate the safety and tolerability of UA026 tablets after oral administration in adult patients with moderate to severe psoriasis.
Secondary objectives:
To evaluate the pharmacokinetic characteristics of UA026 tablets after single and multiple oral administration in healthy adult subjects;
To evaluate the pharmacokinetic characteristics of UA026 tablets after oral administration in adult patients with moderate to severe psoriasis;
To evaluate the effect of food on the pharmacokinetics of the drug after single administration of UA026 tablets on an empty stomach and after meals in healthy adult subjects;
To evaluate the preliminary efficacy of UA026 in adult patients with moderate to severe psoriasis;
To evaluate the changes in pharmacodynamic biomarkers of UA026 in healthy adult subjects and adult patients with moderate to severe psoriasis.
Exploratory objectives:
To explore the changes in QT/QTc interval after oral administration of UA026 tablets in healthy adult subjects.