[Translation] A multicenter, randomized, double-blind, positive-controlled phase II clinical study to evaluate the efficacy and safety of WXSH0102 tablets in the treatment of vulvovaginal candidiasis (VVC)

主要目的：评价WXSH0102片治疗中国成年外阴阴道念珠菌病患者初步疗效及剂量与疗效之间的关系；次要目的：评价WXSH0102片治疗中国成年外阴阴道念珠菌病患者的安全性；评价WXSH0102片在中国成年外阴阴道念珠菌病患者的药代动力学特征；评价WXSH0102片对中国成年外阴阴道念珠菌病患者感染真菌种属的敏感性。

[Translation]

Main purpose: To evaluate the preliminary efficacy of WXSH0102 tablets in treating Chinese adult patients with vulvovaginal candidiasis and the relationship between dose and efficacy; Secondary purpose: To evaluate the safety of WXSH0102 tablets in treating Chinese adult patients with vulvovaginal candidiasis; To evaluate the pharmacokinetic characteristics of WXSH0102 tablets in Chinese adult patients with vulvovaginal candidiasis; To evaluate the sensitivity of WXSH0102 tablets to the fungal species infecting Chinese adult patients with vulvovaginal candidiasis.

Start Date13 Jan 2025

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

CTR20231761

/ CompletedPhase 1

WXSH0102片在健康成人受试者中单次和多次给药的安全性、耐受性、药代动力学及食物影响的Ⅰ期临床试验

[Translation] Phase I clinical trial of the safety, tolerability, pharmacokinetics and food effects of single and multiple doses of WXSH0102 tablets in healthy adult subjects

主要目的：1）评估健康成人单次服用WXSH0102片后的安全性和耐受性；2）评估健康成人多次服用WXSH0102片后的安全性和耐受性。次要目的：1）评估健康成人单次服用WXSH0102片后的药代动力学（PK）特征；2）评估健康成人多次服用WXSH0102片后的PK特征；3）评估食物对健康成人服用WXSH0102片后的PK的影响。

[Translation]

Primary objectives: 1) To evaluate the safety and tolerability of WXSH0102 tablets after a single dose in healthy adults; 2) To evaluate the safety and tolerability of WXSH0102 tablets after multiple doses in healthy adults. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of WXSH0102 tablets after a single dose in healthy adults; 2) To evaluate the PK characteristics of WXSH0102 tablets after multiple doses in healthy adults; 3) To evaluate the effect of food on the PK of WXSH0102 tablets after healthy adults take them.

Start Date19 Jun 2023

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

100 Clinical Results associated with WXSH0102

100 Translational Medicine associated with WXSH0102

100 Patents (Medical) associated with WXSH0102

100 Deals associated with WXSH0102

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	Phase 2	CN	Cisen Pharmaceutical Ltd.	13 Jan 2025
Candidemia	Phase 1	CN	Cisen Pharmaceutical Ltd.	19 Jun 2023

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