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

Phase 1

Recruiting

• Conditions: Bacterial Infections
• Interventions: Drug: Xeruborbactam; Drug: Dextrose 5% in water; Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol

• Registration Number: NCT06547554
• Lead Sponsor: Qpex Biopharma, Inc.

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.

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.

Study Timeline

• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Study Start: 2024-09-04
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 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 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single Dose Cohorts	Xeruborbactam	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Single Dose Cohorts	Cefiderocol	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Single Dose Cohorts	Xeruborbactam/Cefiderocol	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Multiple Dose Cohort Xeruborbactam	Xeruborbactam	Administered multiple fixed doses of Xeruborbactam
Multiple Dose Cohort Cefiderocol	Cefiderocol	Administered multiple fixed doses of Cefiderocol
Multiple Dose Cohort Cefiderocol and Xeruborbactam	Xeruborbactam/Cefiderocol	Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam.
Multiple Dose Cohort Placebo	Dextrose 5% in water	Administered multiple fixed volumes of a placebo comparator
Single Dose Cohorts Placebo	Dextrose 5% in water	Administered single fixed volume of a placebo comparator

Primary Outcome Measures

Name	Time	Method
The incidence and nature of treatment emergent adverse events (TEAE)	up to day 17 or up to day 21	Summarized by cohort
Number of patients with changes from baseline in safety parameters	up to day 17 or up to day 21	Summarized by cohort
Maximum plasma concentration (Cmax)	up to day 17 or up to day 21	Summarized by cohort
Time to maximum plasma concentration (Tmax)	up to day 17 or up to day 21	Summarized by cohort
Area under the plasma concentration versus time curve (AUC)	up to day 17 or up to day 21	Summarized by cohort
Terminal elimination half-life (t1/2,z)	up to day 17 or up to day 21	Summarized by cohort
Terminal elimination rate constant (λz)	up to day 17 or up to day 21	Summarized by cohort
Total clearance (CL)	up to day 17 or up to day 21	Summarized by cohort
Renal clearance (CLR)	up to day 17 or up to day 21	Summarized by cohort
Fraction of dose excreted in urine (Feu)	up to day 17 or up to day 21	Summarized by cohort

Trial Locations

Locations (1)

Minneapolis Clinic; 🇺🇸 Minneapolis, Minnesota, United States