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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: SHR8008; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05074602

SHR8008-301

Details and patient eligibility

About

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis

Enrollment: 196 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females, ≥18 and ≤75 years old.
2. Have a history of RVVC at screening.
3. Suitable for oral therapy and able to swallow capsules intact.
4. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
5. Willing to sign the informed consent form to participate in this study.

Exclusion criteria

1. Presence of concomitant vulvovaginitis caused by other pathogens.
2. Have a 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 (not applicable to subjects with a history of total hysterectomy).
3. Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
4. Moderate to severe hepatic and/or renal disorders.
5. Significant laboratory abnormality at screening.
6. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
7. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
8. Have received any estrogen replacement therapy or vaginal topical products.
9. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
10. Have planned surgery or other medical procedures that may impact compliance with the protocol;
11. Known history of hypersensitivity or intolerance to azole antifungal drugs.
12. History of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol.
13. Women who are pregnant or lactating, or planning to become pregnant during the study period.
14. Have received VT-1161 study medication in a previous study or received any investigational medicinal product (IMP) in a clinical study within 5 half-lives of that IMP prior to screening (if the half-life is unknown, 60 days prior to screening);
15. other conditions unsuitable for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups

SHR8008

Experimental group

Treatment:

Drug: SHR8008

Fluconazole

Active Comparator group

Treatment:

Drug: Fluconazole