Delving into the Latest Updates on Wuhan Kangfude Urolithiasis Institute Co., Ltd with Synapse

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Urogenital Diseases

Small molecule drug

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Small molecule drug	1

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.

Start Date08 Mar 2023

Sponsor / Collaborator

Wuhan Kangfude Urolithiasis Institute Co., Ltd

CTR20221023

/ CompletedPhase 1

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

Start Date01 Jul 2022

Sponsor / Collaborator

Wuhan Kangfude Urolithiasis Institute Co., Ltd

CTR20263231

/ Not yet recruitingPhase 2

评价肠源性高草酸尿症试验参与者口服重组草酸脱羧酶散的有效性和安全性的平行、随机、双盲、安慰剂对照 II 期临床研究

[Translation] A parallel, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy and safety of oral recombinant oxalate decarboxylase powder in participants with enterogenic hyperoxaluria.

主要目的评价重组草酸脱羧酶散在肠源性高草酸尿症试验参与者中的有效性。次要目的评价重组草酸脱羧酶散在肠源性高草酸尿症试验参与者中的安全性；评价重组草酸脱羧酶散对肠源性高草酸尿症试验参与者血浆甲酸（草酸代谢物）浓度的影响；评价重组草酸脱羧酶散在肠源性高草酸尿症试验参与者中的药代动力学（PK）特征。

[Translation]

Primary Objective: To evaluate the efficacy of recombinant oxalate decarboxylase powder in participants of a trial for enterogenic hyperoxaluria. Secondary Objectives: To evaluate the safety of recombinant oxalate decarboxylase powder in participants of a trial for enterogenic hyperoxaluria; to evaluate the effect of recombinant oxalate decarboxylase powder on plasma formic acid (oxalate metabolite) concentrations in participants of a trial for enterogenic hyperoxaluria; to evaluate the pharmacokinetic (PK) characteristics of recombinant oxalate decarboxylase powder in participants of a trial for enterogenic hyperoxaluria.

Start Date-

Sponsor / Collaborator

Wuhan Kangfude Urolithiasis Institute Co., Ltd

100 Clinical Results associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd

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0 Patents (Medical) associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd

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100 Deals associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd

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100 Translational Medicine associated with Wuhan Kangfude Urolithiasis Institute Co., Ltd

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Pipeline

Pipeline Snapshot as of 10 Sep 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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