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

Inclusion criteria

• Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
• Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
• Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion criteria

• Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
• Known HIV, chronic hepatitis B, or hepatitis C infection.
• Known concomitant infection which would require additional systemic antibiotics.
• Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
• Current use of corticosteroid drugs or other immunosuppressive therapy.
• Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
• Known significant renal, hepatic, or hematologic impairment.
• History of intolerance or hypersensitivity to macrolide antibiotics.
• 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).