Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

• Status: Completed
• Trial end date: 2019-09-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melinta Therapeutics, Inc.
• Treatments: Oritavancin

Criteria

Inclusion Criteria:

Subjects may be included in the study if they meet all of the following criteria:

1. Subject must be 18 years of age or older, male or female, and of any race.

2. Subject must give written informed consent before initiation of any study-related procedures.

3. Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy.

4. If female, the subject is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 highly effective methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) for the duration of the study until 60 days after study drug administration, or male partner sterilization alone.

5. Subject must express a commitment to comply with all study visits, procedures and requirements for the duration of the study.

Exclusion Criteria

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

1. Infections associated with, or in close proximity to, a prosthetic device.

2. Severe sepsis or refractory shock.

3. Known or suspected bacteremia at time of screening.

4. ABSSSI due to or associated with any of the following:

1. Infections suspected or documented to be caused by only Gram-negative pathogens (i.e., infections acquired during prolonged admission in hospital or long-term care facilities).

2. Diabetic foot infections (infection extending distal to the malleoli in a subject with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot).

3. Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis).

4. Infected burns.

5. A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa.

6. Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).

7. Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection).

8. Infections known to be caused by an organism resistant to oritavancin.

9. Catheter site infections.

5. Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study.

6. Subjects currently receiving anticoagulant therapy.

7. Known liver function tests (LFTs) ≥ 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 times ULN.

8. Any medical condition, which in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.

9. Any planned, major surgical procedure during the study period (Day 15).

10. Subject is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.

11. Known hypersensitivity to oritavancin, glycopeptides or HPβCD.

12. Female subject who has a positive pregnancy test or is breastfeeding.

13. Previous use of oritavancin or anticipated need to use a long acting glycopeptide during the study.