A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis
Inclusion Criteria:
1. Female participants, 18-65 years of age, inclusive.
2. Clinical diagnosis of symptomatic VVC or RVVC confirmed at baseline by positive KOH wet mount (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/pseudohyphae and/or budding yeast cells).
* VSS ≥ 5 with ≥2 signs
* KOH or wet prep ≥ budding yeast or pseudohyphae
* Vaginal pH ≤ 4.5
* Positive culture for Candida at baseline
3. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline.
4. Presence of at least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation) as reported by the subject at baseline.
5. Have a body weight range of ≥45kg/99 lbs to ≤110 kg/242 lbs and a body mass index (BMI) of 18-35 kg/m2.
6. Participant is not menstruating at Screening or Day 1 and, based on her menstrual cycle history, is not expected to menstruate during the 7-day intravaginal dosing period.
7. In good general health with no clinically relevant abnormalities based on the medical history, vital signs, physical examination, clinical laboratory evaluations (hematology and clinical chemistry), and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator and sponsor, would affect participant's safety.
8. Participants who are not surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit and agree to continue such use throughout the duration of the study. Reliable forms of contraception include intrauterine devices in place for at least 3 months, oral hormonal contraceptives, and abstinence. Women of childbearing potential must have a negative serum pregnancy test (beta-HCG) at screening and Day 1.
9. Participants must be non-lactating.
10. Able to provide written informed consent.
11. Able to comply with all protocol-specified assessments and the study visit schedule.
Exclusion Criteria:
1. Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease.
2. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
3. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
4. Allergy to any of the components of OCF001 or similar compounds.
5. Women not consenting for sexual abstinence from day 1 to day 10 and on days of drug product administration.
6. Pregnant or breastfeeding women excluded
7. Positive pregnancy test at screening excludes
8. Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline.
9. Prescription medications that have not been taken on a stable dosing regimen for at least 30 days.
10. Participants must not use any systemic (e.g., oral or injectable) corticosteroid therapy during the study or within 30 days prior to Screening. However, use of topical (no vulvar or vaginal steroids), inhaled, ophthalmic, intraarticular and intralesional steroids is permitted.
11. Participants must not have received an immunosuppressive medication (e.g. cyclosporine, tacrolimus, methotrexate, etc.), or radiation therapy within 3 months prior to Screening or have a medical condition where it would be likely that the participant may need to use these therapies during the study.
12. Use of any intravaginal prescription medication or over-the-counter products within 14 days before administration of study medication.
13. Presence of any significant vulvar or vaginal lesions.
14. Presence of a vaginal discharge consistent with Chlamydia, Trichomonas or bacterial vaginosis. Mixed infections of fungi and parasitic/bacterial origin.
15. Findings of an abnormal PAP smear (ASCUS allowable), abnormal vaginal pH or positive Chlamydia/Gonorrhea testing.
16. Presence of inguinal adenopathy.
17. Donation of blood over 500 mL within three months prior to Screening.
18. Participants must not be using drugs with a narrow therapeutic index that are metabolized by CYP3A4 and sensitive to induction or inhibition of CYP3A4, CYP2C9 and CYP2C19 during the study.
19. Serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST) \>2.5x the upper limit of normal (ULN) of the reference range.
20. Serum creatinine elevation \> 2.0 mg/dL
21. Serum total bilirubin \>1.5x the ULN of the reference range, unless the elevation is consistent with Gilbert's Syndrome.
22. QTcF interval≥500 ms as corrected by the Fridericia formula or QTcF interval change from baseline \>60 ms, or any clinically significant electrocardiographic abnormality.
Locations (1)
UAB Sexual Health Research Clinic
Birmingham, Alabama, United States
Outcomes
Primary Outcomes
To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product
Proportion of subjects achieving clinical cure at the Early Response, Test-of-Cure (TOC), and Sustained Response visits (Days 4, 8, and 25), defined as a VSS composite score, VSS total score = 0, and no requirement for additional systemic or topical antifungal therapy for VVC between baseline and TOC.
Time frame: 7 days
Evaluate the safety and local tolerability of OCF001 (drug product) intravaginal formulation in women with moderate-to-severe acute VVC.
Incidence, severity, and relationship to study drug of treatment-emergent adverse events (TEAEs) from first dose through the end-of-study visits (including local vulvovaginal AEs).