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WXWH0226在健康成人受试者中单次和多次给药的安全性、耐受性和药代动力学特征的Ia期临床研究
[Translation] Phase Ia clinical study on the safety, tolerability and pharmacokinetic characteristics of single and multiple doses of WXWH0226 in healthy adult subjects
(1)主要目的:评估健康成人空腹条件下,单次口服WXWH0226后的安全性和耐受性;评估健康成人多次口服WXWH0226后的安全性和耐受性;
(2)次要目的:评估健康成人空腹条件下单次口服WXWH0226后的药代动力学特征;评估健康成人多次口服WXWH0226后的药代动力学特征;评估食物对WXWH0226药代动力学特征的影响。
[Translation] (1) Primary objectives: To evaluate the safety and tolerability of WXWH0226 after a single oral dose in healthy adults on an empty stomach; To evaluate the safety and tolerability of WXWH0226 after multiple oral doses in healthy adults;
(2) Secondary objectives: To evaluate the pharmacokinetic characteristics of WXWH0226 after a single oral dose in healthy adults on an empty stomach; To evaluate the pharmacokinetic characteristics of WXWH0226 after multiple oral doses in healthy adults; To evaluate the effect of food on the pharmacokinetic characteristics of WXWH0226.
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