Not Yet RecruitingPhase 2

Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

United States36 participantsStarted 2026-04-20

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion 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).
✓. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline.
✓. Presence of at least one vulvovaginal symptom (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 serum pregnancy test (beta-HCG) at screening and Day 1.

Exclusion criteria

✕. Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease.
✕. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
✕. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
✕. Allergy to any of the components of OCF001 or similar compounds.
✕. Women not consenting for sexual abstinence from day 1 to day 10 and on days of drug product administration.
✕. Pregnant or breastfeeding women excluded
✕. Positive pregnancy test at screening excludes
✕. 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.

What they're measuring

To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product

Timeframe: 7 days

Evaluate the safety and local tolerability of OCF001 (drug product) intravaginal formulation in women with moderate-to-severe acute VVC.

Timeframe: 4 weeks

Trial details

NCT IDNCT07521137

SponsorSano Chemicals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

James Smith

662-574-5957 jsmith@sanochemicals.com

View on ClinicalTrials.gov More Candidiasis, Vulvovaginal trials