A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Last updated: February 23, 2025
Sponsor: Qpex Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Bacterial Infections

Treatment

Xeruborbactam/Cefiderocol

Xeruborbactam

Cefiderocol

Clinical Study ID

NCT06547554
QPEX-400
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 18 to 55 years of age (inclusive) at the time of signing theinformed consent.

  • Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)

  • Subjects must be judged to be in good health based upon the results of a medicalhistory, physical examination, vital signs, 12-lead electrocardiogram and laboratoryprofile

  • Voluntary consent to participate in the study.

Exclusion

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal,hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,or psychiatric disease.

  • A subject with active drug or alcohol abuse within 2 years prior to the initialstudy drug administration

  • Females who are pregnant or lactating

  • Documented hypersensitivity reaction or anaphylaxis to any medication. History ofany severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or anyother beta-lactam antibacterial drugs, or any other excipients used in theformulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Xeruborbactam/Cefiderocol
Phase: 1
Study Start date:
September 04, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Qpex Biopharma, Inc. is developing xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases in combination with a beta-lactam antibiotic.

Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Connect with a study center

  • Minneapolis Clinic

    Minneapolis, Minnesota 55114
    United States

    Active - Recruiting

  • Nucleus Network Minneapolis Clinic

    Minneapolis, Minnesota 55114
    United States

    Site Not Available

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