A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients

NCT06771063 | Recruiting Phase 2

• 1 other identifier: WXSH0102-02-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.

Conditions

Vaginitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving cure at the D11±2 visit.

  Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D11±2 visit.

  day 11±2

Secondary Outcomes (12)

• Proportion of subjects achieving clinical cure at the D11±2 visit

  day 11±2

• Proportion of subjects achieving mycological clearance at the D11±2 visit

  day 11±2

• Proportion of subjects achieving clinical improvement at the D11±2 visit

  day 11±2

• Difference in VVC scale scores between the D11±2 visit and baseline visit

  day 11±2

• Proportion of subjects achieving cure at the D25±3 visit.

  Day 25±3

Study Arms (4)

Arm A : WXSH0102 Day1 1400 mg Day2-3 700

EXPERIMENTAL

Arm A will receive WXSH0102 tablets with a loading dose of 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days

Drug: WXSH0102/placebo

Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm

EXPERIMENTAL

Arm B will receive WXSH0102 tablets with a loading dose of 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days

Drug: WXSH0102/placebo

C : WXSH0102 Day1 600 mg Day2-3 300

EXPERIMENTAL

Arm C will receive WXSH0102 tablets with a loading dose of 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days

Drug: WXSH0102/placebo

Arm D: fluconazole

ACTIVE COMPARATOR

Arm D (active control group) will receive fluconazole capsules for only one day on D1

Drug: fluconazole capsules/placebo

Interventions

WXSH0102/placebo DRUG

Administer WXSH0102 tablets/placebo orally.

Arm A : WXSH0102 Day1 1400 mg Day2-3 700; Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm; C : WXSH0102 Day1 600 mg Day2-3 300

fluconazole capsules/placebo DRUG

Administer fluconazole capsules/placebo orally

Arm D: fluconazole

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects understood and voluntarily signed the informed consent Form (ICF), and were willing and able to comply with the study protocol.
• Female participants who signed ICF at the age of 18-64 years (including the cut-off value) and had sexual intercourse;
• Participants were diagnosed with VVC and met each of the following criteria: a. At screening, the total score on the VVC scale was ≥4 and at least two of the symptoms or signs on the VVC scale were present; b. A vaginal discharge sample collected at screening was Gram stain positive for Candida (hypha/pseudohypha/budding); c. Vaginal pH ≤4.5; Symptoms: vulvovaginal itching, vulvar burning pain, dyspareunia and urination pain, excessive secretion, secretion is tofu residue like; Physical signs: gynecological examination showed vulvar hyperemia and edema, which may be accompanied by scratches. In severe cases, chapped skin, exfoliation and even erosion could be seen. Vaginal mucosa was hyperemic, vaginal secretion was curd or tofu residue like;
• Subjects who are capable of oral administration;
• For the duration of the study, participants agreed to abstain from sexual activity and to use the condom throughout sexual activity.

You may not qualify if:

• Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
• Subjects with any vulvovaginal or cervical disease that may affect the diagnosis and evaluation of VVC;
• Topical or systemic antifungal treatment for VVC within 14 days before randomization;
• Significant liver disease or abnormal liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] \> 1.5 ULN); Patients with severe renal disease or renal insufficiency (glomerular filtration rate (GFR) \< 60ml/min/1.73m2 );
• Patients who planned to undergo treatment or surgery for vulvar, vaginal or cervical lesions during the study period;
• Severe gastrointestinal disease or other conditions that may affect the absorption of the trial drug;
• Patients with severe heart, lung, liver, kidney dysfunction and hematopoietic system diseases;

Sponsors & Collaborators

• Cisen Pharmaceutical CO., LTD.: lead

Study Sites (2)

251 Yaojiayuan Road, Chaoyang District, Beijing

Beijing, Beijing Municipality, 100025, China

NOT YET RECRUITING

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, 100025, China

RECRUITING

MeSH Terms

Conditions

Vaginitis

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Zhaohui Liu, professor

CONTACT

13701118639; 23662161@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 13, 2025
• Study Start: January 13, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (2)