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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

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

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Dextrose 5% in water; Drug: Xeruborbactam; Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55114
      • Minneapolis Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose Cohorts; Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.	Drug: Xeruborbactam; Experimental; Other Names: QPX7728; Drug: Cefiderocol; Experimental; Drug: Xeruborbactam/Cefiderocol; A combination of Xeruborbactam and Cefiderocol.
Experimental: Multiple Dose Cohort Xeruborbactam; Administered multiple fixed doses of Xeruborbactam	Drug: Xeruborbactam; Experimental; Other Names: QPX7728
Experimental: Multiple Dose Cohort Cefiderocol; Administered multiple fixed doses of Cefiderocol	Drug: Cefiderocol; Experimental
Experimental: Multiple Dose Cohort Cefiderocol and Xeruborbactam; Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam.	Drug: Xeruborbactam/Cefiderocol; A combination of Xeruborbactam and Cefiderocol.
Placebo Comparator: Multiple Dose Cohort Placebo; Administered multiple fixed volumes of a placebo comparator	Drug: Dextrose 5% in water; Placebo
Placebo Comparator: Single Dose Cohorts Placebo; Administered single fixed volume of a placebo comparator	Drug: Dextrose 5% in water; Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qpex Biopharma, Inc.
• Collaborators: Shionogi Inc.; Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): October 27, 2025
• Study Completion (Actual): October 27, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: beta-lactamase inhibitor
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Amides; Inorganic Chemicals; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Oxides; Oxygen Compounds; Sugars; beta-Lactams; Lactams; Cephalosporins; Thiazines; Hexoses; Monosaccharides; QPX7728; Cefiderocol; Water; Glucose
• Other Study ID Numbers: QPEX-400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No