[Translation] The first human, single-center, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of single and multiple doses of WS016 in Chinese healthy people
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] Main objective: To evaluate the tolerability and safety of single-dose-escalation and multiple-dose-escalation oral administration of WS016 in healthy subjects.
Secondary objectives: To study the pharmacodynamic (PD) characteristics of single dose escalation and multiple dose escalation of oral WS016 in healthy subjects, to evaluate the changes in serum potassium, urine and fecal excretion of potassium concentration from baseline, as II Provide the basis for the dosing regimen of clinical trials.
Exploratory purpose: To explore the effect of oral administration of WS016 on blood electrolytes (sodium, magnesium, calcium) in healthy subjects.