评估WS012在中国健康成人受试者中的安全性、耐受性和药效动力学的随机、双盲、安慰剂对照的单、多剂量递增的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose ascending phase I clinical study to evaluate the safety, tolerability, and pharmacodynamics of WS012 in healthy Chinese adult subjects
主要目的:
评估WS012在中国健康成人受试者中单次和多次口服给药的安全性和耐受性。
次要目的:
评估WS012在中国健康成人受试者中单次和多次口服给药的总胆汁酸(TBA)和粪便中TBA的药效动力学。
探索性目的:
探索健康受试者多次口服给药WS012对血脂(TG、TC、HDL-C、LDL-C)的影响。
[Translation] Primary objective:
To evaluate the safety and tolerability of WS012 after single and multiple oral administration in healthy Chinese adult subjects.
Secondary objective:
To evaluate the pharmacodynamics of total bile acid (TBA) and fecal TBA in WS012 after single and multiple oral administration in healthy Chinese adult subjects.
Exploratory objective:
To explore the effects of multiple oral administration of WS012 on blood lipids (TG, TC, HDL-C, LDL-C) in healthy subjects.
WS016干混悬剂治疗高钾血症的有效性和安全性的多中心、随机、双盲、安慰剂平行对照、剂量探索Ⅱ期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding phase II clinical study on the efficacy and safety of WS016 dry suspension in the treatment of hyperkalemia
初步评价WS016干混悬剂治疗高钾血症的有效性和安全性。
[Translation] To preliminarily evaluate the efficacy and safety of WS016 dry suspension in the treatment of hyperkalemia.
首次人体、单中心、随机、双盲、安慰剂对照评价WS016在中国健康人中单次和多次给药的安全性、耐受性研究
[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.
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