Cempra Inc. CEMP today announced the dosing of the first two patients enrolled in a Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of solithromycin in the treatment of uncomplicated urogenital gonococcal infections.
The Phase 2 clinical trial is an open-label, single-center study of 30 patients with clinically-proven uncomplicated gonorrhea that will be treated with a single 1,200 mg oral dose of solithromycin. The primary outcome will be bacterial eradication at test of cure, which is seven days after treatment. Safety and tolerability outcome measures will be investigated.
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