[Translation] A first-in-human, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of WS016 in healthy Chinese subjects after single and multiple doses
主要目的:评估健康受试者单次剂量递增和多次剂量递增口服WS016的耐受性和安全性。
次要目的:研究健康受试者中单次剂量递增和多次剂量递增口服WS016的药效动力学(PD)特征,评估血清钾、尿液和粪便排泄钾的浓度较基线的变化,为II期临床试验的给药方案提供依据。
探索性目的:探索健康受试者口服WS016对血液电解质(钠、镁、钙)的影响。
[Translation] Primary objective: To evaluate the tolerability and safety of single-dose ascending and multiple-dose ascending oral administration of WS016 in healthy subjects.
Secondary objective: To study the pharmacodynamic (PD) characteristics of single-dose ascending and multiple-dose ascending oral administration of WS016 in healthy subjects, evaluate the changes in serum potassium, urine and fecal potassium excretion compared with baseline, and provide a basis for the dosing regimen of Phase II clinical trials.
Exploratory objective: To explore the effects of oral administration of WS016 on blood electrolytes (sodium, magnesium, calcium) in healthy subjects.