/ Not yet recruitingPhase 2 评价继发性高草酸尿症患者口服重组草酸脱羧酶散的安全性和有效性的多中心、随机、双盲、安慰剂对照 II 期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the safety and efficacy of oral recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria
主要目的: 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的有效性; 次要目的: 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的安全性; 评价重组草酸脱羧酶散对继发性高草酸尿症患者血浆甲酸(草酸代谢物)浓度的影响; 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的药代动力学(PK)特征。
[Translation] Primary objective: To evaluate the effectiveness of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria; Secondary objective: To evaluate the safety of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria; To evaluate the effect of recombinant oxalate decarboxylase powder on the plasma formic acid (oxalate metabolite) concentration in patients with secondary hyperoxaluria; To evaluate the pharmacokinetic (PK) characteristics of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria.
单中心、随机、双盲、剂量递增、安慰剂对照设计,评价重组草酸脱羧酶散在中国成年健康受试者中单次给药及多次给药的安全性、耐受性临床试验
[Translation] A single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial to evaluate the safety and tolerability of single and multiple doses of recombinant oxalate decarboxylase powder in healthy adult Chinese subjects
评价重组草酸脱羧酶散在中国成年健康受试者中的安全性、耐受性
[Translation] To evaluate the safety and tolerability of recombinant oxalate decarboxylase powder in healthy Chinese adult subjects
100 Clinical Results associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd
0 Patents (Medical) associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd
100 Deals associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd
100 Translational Medicine associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd