Status:
COMPLETED
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
Lead Sponsor:
Qpex Biopharma, Inc.
Collaborating Sponsors:
Shionogi Inc.
Biomedical Advanced Research and Development Authority
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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
Detailed 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....
Eligibility Criteria
Inclusion
- Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed 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 medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
- Voluntary consent to participate in the study.
Exclusion
- 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 initial study drug administration
- Females who are pregnant or lactating
- Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06547554
Start Date
September 4 2024
End Date
October 27 2025
Last Update
November 28 2025
Active Locations (1)
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1
Minneapolis Clinic
Minneapolis, Minnesota, United States, 55114