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
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
∙ Participants will be selected for study participation, if they meet the following criteria:
• Female participants, 18-65 years of age, inclusive.
• 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
⁃ KOH or wet prep positive for budding yeast or pseudohyphae
⁃ Vaginal pH ≤ 4.5
• Presence of at least one vulvovaginal sign be of at least moderate severity (vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline.
• Presence of at least one vulvovaginal symptom be of at least moderate severity (vulvovaginal itching, burning, or irritation) as reported by the subject at baseline.
• 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.
• 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.
• 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.
• 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 urine pregnancy test at screening and Day 1.
• Participants must be non-lactating.
⁃ Able to provide written informed consent.
⁃ Able to comply with all protocol-specified assessments and the study visit schedule.