Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Sano Chemicals Inc
Study ID: NCT07521137
Phase: PHASE2
Status: Not Yet Recruiting

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Conditions

Candidiasis, Vulvovaginal

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

OCF001 Intravaginal Gel — DRUG
OCF001 is an antifungal antibiotic that is formulated in a water-miscible viscous gel at concentrations of 0.150 mg / g of gel.
Placebo Gel — DRUG
Placebo (Gel formulation without OCF)

Study Details

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

Key Dates

Start date: Apr 20, 2026
Status verified: Apr 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2026

Study Design

Enrollment: 36 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Occidiofungin
Participants will receive 5 g of OCF001 vaginal gel once daily for 7 days.
Placebo Comparator: Placebo
Participants will receive 5 g of placebo vaginal gel once daily for 7 days

Primary Outcome Measure

To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product [ Time Frame: 7 days ]

Central Contacts

James Smith
662-574-5957
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
UAB Sexual Health Research Clinic	Birmingham	Alabama	35203	Christina Muzny, MD, MSPH

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UAB Sexual Health Research Clinic· Birmingham, AL