Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

Inclusion Criteria:

1. Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain,
sexual contact)

2. Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms
until study completion.

3. Females of childbearing potential (including females less than 2 years
post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

1. Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic
inflammatory disease, arthritis, or endocarditis.

2. Known HIV, chronic hepatitis B, or hepatitis C infection.

3. Known concomitant infection which would require additional systemic antibiotics.

4. Use of systemic or intravaginal antibiotics within 30 days prior to study drug
administration.

5. Current use of corticosteroid drugs or other immunosuppressive therapy.

6. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.

7. Known significant renal, hepatic, or hematologic impairment.

8. History of intolerance or hypersensitivity to macrolide antibiotics.

9. Any concomitant condition that, in the opinion of the Investigator, would preclude an
evaluation of a response or make it unlikely that the contemplated course of therapy
and follow-up could be completed (e.g., life expectancy <30 days).