Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic
parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females
following single dose administration (Part 1), and in nonpregnant women with vaginitis
following multi-dose administration (Part 2).

Inclusion Criteria:

- Adult women of any race between 18 to 45 years of age (inclusive).

- Subjects must be able to give voluntary written informed consent before any study
related procedure is performed.

- Subjects must have a negative serum pregnancy test at Screening and negative urine
pregnancy test at all other clinical site visits, as applicable.

- Subjects either have no childbearing potential (as defined below) (Note 1) or agree
to avoid becoming pregnant from the day of screening through one month after the last
study Day using one of the following acceptable methods of birth control (Note 2) in
addition to the use of non-lubricated condoms by the male partner (even if
vasectomized).

- Hormonal contraceptives

- Abstinence

- Note 1: Non-childbearing potential is defined as being post-menopausal for at
least 2 years, status after bilateral tubal ligation for at least 1 year, status
after bilateral oophorectomy or status after hysterectomy.

- Note 2: Intravaginal or intra-uterine contraceptives and contraceptive devices
(IUDs) are not acceptable forms of birth control for this study.

- Subjects must agree to refrain from douching or using any intravaginal products
(i.e., contraceptive creams, gels, foams, sponges, lubricants, etc.) or IUDs during
the study period.

- Subjects must agree not to donate blood during the study and up to 14 days after the
end of the study.

- Subjects willing and able to comply with all study requirements.

For Part 1 Only

- Subjects must be healthy as determined by medical history, physical examination,
vital signs, pelvic examination and laboratory evaluations (hematology, clinical
chemistry and urinalysis tests) within study-defined ranges at Screening.

- Subjects must be without current symptomatic or asymptomatic bacterial vaginosis,
candida vulvovaginitis or any other form of vaginitis by clinical and microbiologic
testing.

- Subjects must be willing to abstain from sexual intercourse for 24 hours prior to
each site visit.

For Part 2 Only

- Subjects with vaginitis must be otherwise healthy based on medical history, physical
examination, vital signs, pelvic examination and laboratory evaluations (hematology,
clinical chemistry and urinalysis tests) within study-defined ranges at Screening.

- Subjects with vaginitis must be willing to abstain from sexual intercourse 24 hours
prior to the first dose of study medication and throughout the last visit of the
study.

Exclusion Criteria:

- A history of clinically significant acute illness (resolved within 4 weeks of
screening) or any other condition which, in the opinion of the Site Principal
Investigator (PI), would jeopardize the safety of the subject or impact the validity
of the study results.

- Subjects with intrauterine devices.

- Subjects with renal dysfunction (serum creatinine >/= 1.2 mg/dL).

- Subjects with underlying metabolic or endocrine dysfunction, such as diabetes
mellitus, Cushing's disease, Addison's disease, or hypo- or hyperthyroidism.

- Subjects who test positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis
C antibody.

- Subjects who have diseases known to cause immunodeficiency, e.g., AIDS, advanced
malignancy, anemia or severe vitamin deficiency.

- Subjects who test positive for Trichomonas vaginalis, Neisseria gonorrhea, or
Chlamydia trachomatis at screening.

- Subjects with active genital lesions at screening, including syphilitic chancre,
herpetic lesions, or genital warts (HPV).

- Subjects who have had major surgery within 4 weeks of screening.

- Subjects with an uncontrolled active illness (e.g., active infection) or fever (oral
temperature >/=100 degrees F or >/= 37.7 degrees C) at screening.

- Subjects with a known sensitivity to any ingredient in TOL-463 vaginal gel or ovule.

- With the exception of oral contraceptives, use of a prescription medication, notably
antimicrobial agents, corticosteroids or other immuno-suppressants, within 14 days
prior to Day 1 of study treatment, unless in the opinion of the PI, the substance
would not likely impact the conduct or results of this study.

- Subjects with any current unstable medical condition(s) requiring prescription
medication(s) that would preclude accurate evaluation of subjects or otherwise impact
the conduct or results of the study.

- Subjects who have received an investigational drug in a clinical trial within 30 days
prior to screening.

- Women who are pregnant or breast feeding. Subject has a positive history for alcohol
abuse or dependence and/or a positive urine screen test for alcohol and drugs of
abuse [amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana,
opiates, phencyclidine (PCP)] at screening or at any check-in prior to receiving
study drug.

- Subjects who have donated blood within the past 30 days prior to Day 1 of treatment
with study drugs.