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Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

NCT03873987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-04-13

Study results available
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Summary

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

Conditions

  • Acute Bacterial Skin and Skin Structure Infection

Interventions

DRUG

Current Formulation of Oritavancin

Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)

DRUG

Kimyrsa

New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue K Cammarata, MD · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2019-08-27
Completion
2019-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873987 on ClinicalTrials.gov