Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
Completed
Melinta Therapeutics, Inc.
Phase 1
2019-07-16
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa
versus the approved oritavancin formulation in subjects with acute bacterial skin and skin
structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and
reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of
oritavancin
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
Completed
Melinta Therapeutics, Inc.
Phase 1
2019-07-16
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa
versus the approved oritavancin formulation in subjects with acute bacterial skin and skin
structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and
reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of
oritavancin
Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin
Not yet recruiting
Melinta Therapeutics, Inc.
Phase 2
2022-10-31
This protocol describes a randomized, open-label study to evaluate the safety and
tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus
standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute
bacterial skin and skin structure infections (ABSSSIs).
This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the
active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the
differences between ORBACTIV and KIMYRSA by providing product-specific data, and information
and guidance for Investigators. "Oritavancin" is used to describe drug product data, and
information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both).
The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome
assessments. The study was designed to capture adequate data while minimizing the impact to
subjects and their caregivers.
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