Clinical studies in adult subjects with ABSSSI have demonstrated that a single 1200-mg IV dose of oritavancin was clinically non-inferior, well tolerated, and had a similar safety profile to 7 to 10 days of IV vancomycin treatment.~The 1200-mg dose of oritavancin is the United States (US) approved therapeutic dose.~Subjects with ABSSSI will be enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart. The safety information will include the potential for antibody production following two 1200-mg IV infusions of oritavancin.~This study will be a randomized, double-blind study. Subjects will be randomized to receive either two doses of oritavancin or one dose of oritavancin and a single dose of placebo one week apart in order to obtain safety information. This safety information will include information regarding the potential for antibody production following one or two doses of 1200 mg oritavancin.
The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV infusions of oritavancin when administered one week apart.