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

Overview

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis

Full Title of Study: “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)”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: September 30, 2021

Interventions

• Drug: SHR8008 capsule
  • once daily for 2 days(Day 1 and Day 2),oral
• Drug: Fluconazole capsule
  • once daily for 2 days(Every 72 hours) ,oral

Arms, Groups and Cohorts

• Experimental: Treatment group A
  • SHR8008 capsule
• Active Comparator: Treatment group B
  • Fluconazole capsule

Clinical Trial Outcome Measures

Primary Measures

• The proportion of subjects with therapeutic cure
  • Time Frame: Day 28
  • defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Females ≥18 and ≤75 years old; 2. Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining; 3. Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study; 4. Willing to sign the informed consent form to participate in this study. Exclusion Criteria:

1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC; 2. Presence of concomitant vulvovaginitis caused by other pathogens; 3. 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; 4. Moderate to severe hepatic and/or renal disorders; 5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization; 6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization; 7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization; 8. Presence of significant laboratory abnormalities at screening; 9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening; 10. Have planned surgeries or other medical procedures that may impact compliance with the protocol; 11. Known history of hypersensitivity or intolerance to azole antifungal drugs; 12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period; 13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening; 14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening; 15. Other conditions unsuitable for participation in the study per investigator's judgment.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Jiangsu HengRui Medicine Co., Ltd.
• Provider of Information About this Clinical Study
  • Sponsor