A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea

In this study, adults will be administered as one 3g IV dose at the study site,Children under 12 will be administered as one 75mg/kg IV dose . Approximately 100 subjects will be recruited to receive study treatment. The duration of the study will be approximately 14 days.

Inclusion criteria

• Subjects must be >=6 or ≦80 years of age at the time of signing the informed consent,both gender
• Subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc.
• Subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis).
• Male and female subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.

Exclusion criteria

• Subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
• Subject has received any cephalosporinl therapy for the treatment of a gonococcal infection
• Pregnant or lactating women, or women Subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period.
• Famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use.
• Subject has risk of potentially serious drug interactions
• Subject has major diseases such as cardiovascular disease, hepatorenal disease and mental disease, or other factors, the researcher should not participate in the study according to comprehensive judgment
• Subject has a known history of alcohol or drug abuse
• Subject has a known any complicated or systemic gonorrhea infection, such as pelvic inflammatory disease, arthritis, endocarditis