评价 WXSH0176 片在活动性溃疡性结肠炎患者中的有效性、安全性、药代动力学特征的随机、双盲、安慰剂对照的 IIa 期研究
[Translation] A randomized, double-blind, placebo-controlled Phase IIa study to evaluate the efficacy, safety, and pharmacokinetic characteristics of WXSH0176 tablets in patients with active ulcerative colitis
评价 WXSH0176 片在活动性溃疡性结肠炎患者中的初步有效性、安全性和药代动力学特征。
[Translation] To evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of WXSH0176 tablets in patients with active ulcerative colitis.
WXSH0176片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Ⅰ期临床试验
[Translation] Phase I clinical trial of the safety, tolerability and pharmacokinetic characteristics of single and multiple doses of WXSH0176 tablets in healthy adult subjects
主要目的:1)评估健康成人单次服用WXSH0176片后的安全性和耐受性;2)评估健康成人多次服用WXSH0176片后的安全性和耐受性。 次要目的:1)评估健康成人单次服用WXSH0176片后的药代动力学(PK)特征;2)评估健康成人多次服用WXSH0176片后的药代动力学(PK)特征;3)评估食物对健康成人服用WXSH0176片后的药代动力学(PK)的影响。
探索性目的:1)评估健康成人单次服用WXSH0176片后的药效动力学(PD)特征;2)评估健康成人多次服用WXSH0176片后的药效动力学(PD)特征。
[Translation] Primary objectives: 1) To evaluate the safety and tolerability of WXSH0176 tablets after a single dose in healthy adults; 2) To evaluate the safety and tolerability of WXSH0176 tablets after multiple doses in healthy adults. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of WXSH0176 tablets after a single dose in healthy adults; 2) To evaluate the pharmacokinetic (PK) characteristics of WXSH0176 tablets after multiple doses in healthy adults; 3) To evaluate the effect of food on the pharmacokinetics (PK) of WXSH0176 tablets in healthy adults.
Exploratory objectives: 1) To evaluate the pharmacodynamic (PD) characteristics of WXSH0176 tablets after a single dose in healthy adults; 2) To evaluate the pharmacodynamic (PD) characteristics of WXSH0176 tablets after multiple doses in healthy adults.
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