Candidiasis, VulvovaginalPhase 2BLOSSOMNCT07521137
Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence
A Phase 2 study testing OCF001 Intravaginal Gel in people with Candidiasis, Vulvovaginal, run by Sano Chemicals Inc at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- OCF001 Intravaginal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Participants will be excluded from the study, if they meet any of the following 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.
- Absence of microbiological confirmation of Candida infection at baseline, defined as: Negative fungal culture for Candida species obtained from a vaginal specimen collected at the Baseline Visit (Day 1), or Failure to obtain an adequate specimen for culture at baseline.
- 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.
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- Pregnant or breastfeeding women excluded
- Positive pregnancy test at screening
- 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.
- Prescription medications that have not been taken on a stable dosing regimen for at least 30 days.
- 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.
- 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.
- Use of any intravaginal prescription medication or over-the-counter products within fourteen (14) days before administration of study medication.
- Presence of clinically significant vulvar, vaginal, or cervical lesions (including ulcerations, crusted lesions, painful erosions, or genital warts) suggestive of herpes simplex virus (HSV), human papillomavirus (HPV), cervical pathology, or traumatic lesions.
- Presence of a vaginal discharge consistent with Chlamydia, Trichomonas or bacterial vaginosis. Mixed infections of fungi and parasitic/bacterial origin.
- Subjects with signs, symptoms, or diagnostic findings suggestive of other infectious causes of vulvovaginitis or mixed infection (e.g., bacterial vaginosis, Trichomonas vaginalis, sexually transmitted infections, herpes simplex virus, or human papillomavirus), including mucopurulent cervical discharge, signs of cervicitis, pelvic pain, dysuria, or other findings on examination or microscopy that, in the investigator's judgment, are inconsistent with uncomplicated vulvovaginal candidiasis.
- Clinically significant inguinal lymphadenopathy suggestive of an alternative genital infection or other condition inconsistent with uncomplicated vulvovaginal candidiasis.
- Donation of blood over 500 mL within three months prior to Screening.
- 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.
- Serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST) >2.5x the upper limit of normal (ULN) of the reference range.
- Serum creatinine elevation > 2.0 mg/dL
- Serum total bilirubin >1.5x the ULN of the reference range, unless the elevation is consistent with Gilbert's Syndrome.
- QTcF interval≥500 ms as corrected by the Fridericia formula or QTcF interval change from baseline >60 ms, or any clinically significant electrocardiographic abnormality.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Sexual Health Research Clinic
Birmingham, Alabama, 35203
Christina Muzny, MD, MSPH
About this study
Official title: 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
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- OCF001 Intravaginal Gel, Placebo Gel
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCF001 Intravaginal GelDrug
Also called Occidiofungin
OCF001 is an antifungal antibiotic that is formulated in a water-miscible viscous gel at concentrations of 0.150 mg / g of gel.
Placebo GelDrug
Placebo (Gel formulation without OCF)
| Study group | Role | What they receive |
|---|---|---|
| Occidiofungin | Experimental | Participants will receive 5 g of OCF001 vaginal gel once daily for 7 days. Receives: Drug: OCF001 Intravaginal Gel |
| Placebo | Placebo comparator | Participants will receive 5 g of placebo vaginal gel once daily for 7 days Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start4 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sano Chemicals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Muzny, MD, Principal investigator, UAB Sexual Health Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521137
- Sponsor's protocol ID
- OCF001-P2001
- Acronym
- BLOSSOM
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07521137
- Acronym / sponsor ID
- BLOSSOM / OCF001-P2001
- Conditions
- Candidiasis, Vulvovaginal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sano Chemicals IncIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occidiofungin | Experimental | Drug: OCF001 Intravaginal GelParticipants will receive 5 g of OCF001 vaginal gel once daily for 7 days. |
| Placebo | Placebo comparator | Drug: Placebo GelParticipants will receive 5 g of placebo vaginal gel once daily for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
- 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.
Key exclusion criteria (23 listed)
- 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.
- Absence of microbiological confirmation of Candida infection at baseline, defined as: Negative fungal culture for Candida species obtained from a vaginal specimen collected at the Baseline Visit (Day 1), or Failure to obtain an adequate specimen for culture at baseline.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCF001 Intravaginal GelAlso: OccidiofunginOCF001 is an antifungal antibiotic that is formulated in a water-miscible viscous gel at concentrations of 0.150 mg / g of gel. | Drug | Occidiofungin |
| Placebo GelPlacebo (Gel formulation without OCF) | Drug | Placebo |
Primary outcome
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
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.
Evaluate the safety and local tolerability of OCF001 (drug product) intravaginal formulation in women with moderate-to-severe acute VVC.
Time frame: 4 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Muzny, MD principal investigator
UAB Sexual Health Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OCF001 Intravaginal Gel in people with Candidiasis, Vulvovaginal, run by Sano Chemicals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Smith (662-574-5957, jsmith@sanochemicals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.