Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use

This study will begin with a safety run-in, which is an open label, single-arm safety run-in
with 5 women receiving PC-1005 once daily for 3 consecutive days. Safety and
pharmacokinetics will take place after each dose. the participants from the run-in will not
be eligible for the main study.

The main study participants will be randomized 4:1 to the study gels: 24 randomized to
PC-1005 (active) and 6 randomized to HEC gel (placebo). The study product will be applied
vaginally once daily for 14 days with clinical and laboratory assessments at baseline
(enrollment) and after the 1st, 2nd, 8th, 9th, and 14th doses, and a safety follow-up visit
7 days after the 14th dose.

Participants in the run-in and main study will be requested to be sexually abstinent
starting immediately after the Screening Visit until study exit.

Inclusion Criteria:

- Women between 19 and 49 years of age, inclusive

- Willing and able to provide written informed consent

- Healthy, based on medical history, vital signs, physical examination, urinalysis,
laboratory evaluations for genital infections and laboratory evaluations for
hematology, liver and renal function with a BMI ≥18 kg/m^2 and ≤32 kg/m^2

- HIV-negative as determined by HIV ELISA test at screening

- Hepatitis B and C negative at screening

- Rapid plasma reagin negative at screening

- If HSV-2 positive, must be free from outbreaks for at least 6 months prior to
screening

- In the absence of the use of exogenous hormone(s), have a self-reported regular
menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days
between menses

- Normal Pap test at screening

- Agrees to use one form of effective contraception for the duration of the trial

- Willing to abstain from sexual intercourse/activity including receptive vaginal,
oral, digital, and anal intercourse, and the use of any vaginal products including
tampons, male and female condoms, contraceptive sponges, diaphragms, cervical caps,
douches, lubricants, and vibrators/dildos starting from the Screening Visit through
Study Exit

- Agrees to not participate in any other clinical research trial for the duration of
this trial

Exclusion Criteria:

- History of or known sensitivity/allergy to any component of either study product

- Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome

- Participation in any other clinical research trial involving investigational or
marketed products currently or within two months of participation prior to screening,
including any trial of a spermicide, microbicide and/or drug

- Diagnosed with or treated for any STI (other than HSV) or pelvic inflammatory disease
in the last 3 months

- Positive test for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas
vaginalis

- Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract
infection (UTI) at screening

- Presence of any clinically significant genital epithelial findings such as abrasions,
ulcerations, lacerations, or vesicles suspicious for STIs at screening

- Presence of any other clinically significant abnormal physical finding on the vulva,
vaginal walls or cervix at screening

- Any clinically significant abnormal hematology, chemistry or urinalysis findings at
screening

- Any chronic (excluding HSV-2) or progressive disease (including any known history of
cancer, diabetes, cardiac disease, autoimmune disease, blood dyscrasias, or Wilson's
disease), or signs of cardiovascular disease, or renal failure, even controlled with
medication

- History of hysterectomy or menopause

- Use of excluded contraceptive methods including Nuvaring®, condoms (male or female),
contraceptive sponge, diaphragm, or cervical cap (Safety Run-in and Main study)

- History of gynecological surgery or procedure within past 2 months

- History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction
within the last 3 months, including break-through bleeding requiring sanitary
protection

- Known current drug abuse, including illicit drugs, or alcohol abuse

- Any other condition(s) that, in the opinion of the Investigator, might interfere with
adherence to trial requirements or evaluation of the trial objectives

- Unable to comply with study requirements, including but not limited to, attending all
study visits, using the gel as directed, observing abstinence throughout the study
and use of effective contraceptives, limiting alcoholic beverages to 2 per day and
caffeine to no more than 6 servings per day

- History of latex allergy