A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis

Official Title
-----------------
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (VVC)

Conditions
-----------------
Acute Vulvovaginal Candidiasis

Intervention / Treatment
-----------------
* Drug: SHR8008 capsule
* Drug: Fluconazole capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females ≥18 and ≤75 years old; Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining; Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study; Willing to sign the informed consent form to participate in this study. Exclusion Criteria: Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC; Presence of concomitant vulvovaginitis caused by other pathogens; History of cervical cancer, or cervical intraepithelial neoplasia or malignancy or atypical squamous cells of undetermined significance (ASCUS) as indicated by Pap test or other tests reported within 1 year before screening; Moderate to severe hepatic and/or renal disorders; Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization; Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization; Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization; Presence of significant laboratory abnormalities at screening; QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening; Have planned surgeries or other medical procedures that may impact compliance with the protocol; Known history of hypersensitivity or intolerance to azole antifungal drugs; Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period; History of narcotic or drug abuse or alcoholism within 6 months prior to screening; Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening; Other conditions unsuitable for participation in the study per investigator's judgment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>SHR8008 capsule | Drug: SHR8008 capsule<br>* once daily for 2 days(Day 1 and Day 2),oral<br>|
| Active Comparator: Treatment group B<br>Fluconazole capsule | Drug: Fluconazole capsule<br>* once daily for 2 days(Every 72 hours) ,oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with therapeutic cure | defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects therapeutic cure |  | Day 14 | 
| The proportion of subjects with clinical cure | defined as absence of signs and symptoms of VVC | Day 14 and Day 28 | 
| The proportion of subjects with mycological cure | defined as negative culture of vaginal swabs for growth of Candida species | Day 14 and Day 28 | 
| Changes from baseline in VVC signs and symptoms score |  | Day 14 and Day 28 | 
| The proportion of subjects receiving rescue therapy during the study |  | 28 days |