Bacterial InfectionsPhase 1NCT06547554
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
A Phase 1 study testing Xeruborbactam, Cefiderocol and Xeruborbactam/Cefiderocol in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Xeruborbactam, Cefiderocol and Xeruborbactam/Cefiderocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 27 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Xeruborbactam, Cefiderocol, Xeruborbactam/Cefiderocol, Dextrose 5% in water
- Keywords
- beta-lactamase inhibitor
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeruborbactamDrug
Also called QPX7728
Experimental
CefiderocolDrug
Experimental
Xeruborbactam/CefiderocolDrug
A combination of Xeruborbactam and Cefiderocol.
Dextrose 5% in waterDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Cohorts | Experimental | Administered single fixed dose of Xeruborbactam
Administered single fixed dose of Cefiderocol
Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol. Receives: Drug: Xeruborbactam; Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol |
| Multiple Dose Cohort Xeruborbactam | Experimental | Administered multiple fixed doses of Xeruborbactam Receives: Drug: Xeruborbactam |
| Multiple Dose Cohort Cefiderocol | Experimental | Administered multiple fixed doses of Cefiderocol Receives: Drug: Cefiderocol |
| Multiple Dose Cohort Cefiderocol and Xeruborbactam | Experimental | Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam. Receives: Drug: Xeruborbactam/Cefiderocol |
| Multiple Dose Cohort Placebo | Placebo comparator | Administered multiple fixed volumes of a placebo comparator Receives: Drug: Dextrose 5% in water |
| Single Dose Cohorts Placebo | Placebo comparator | Administered single fixed volume of a placebo comparator Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and nature of treatment emergent adverse events (TEAE)
Summarized by cohort
Measured: up to day 17 or up to day 21
Number of patients with changes from baseline in safety parameters
Summarized by cohort
Measured: up to day 17 or up to day 21
Maximum plasma concentration (Cmax)
Summarized by cohort
Measured: up to day 17 or up to day 21
Time to maximum plasma concentration (Tmax)
Summarized by cohort
Measured: up to day 17 or up to day 21
Area under the plasma concentration versus time curve (AUC)
Summarized by cohort
Measured: up to day 17 or up to day 21
Terminal elimination half-life (t1/2,z)
Summarized by cohort
Measured: up to day 17 or up to day 21
Terminal elimination rate constant (λz)
Summarized by cohort
Measured: up to day 17 or up to day 21
Total clearance (CL)
Summarized by cohort
Measured: up to day 17 or up to day 21
Renal clearance (CLR)
Summarized by cohort
Measured: up to day 17 or up to day 21
Fraction of dose excreted in urine (Feu)
Summarized by cohort
Measured: up to day 17 or up to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Sep 2024
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-Blind, Controlled, Crossover, Ascending Single Dose Design and Randomized, Double-Blind, Controlled, Multiple Dose Design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qpex Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc., Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547554
- Sponsor's protocol ID
- QPEX-400
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Pinto L, Gomis-Font MA, Perez-Rodriguez G, Blanco-Martin T, Rodriguez-Pallares S, Sanchez-Pena L, Beceiro A, Bou G, Jeannot K, Oliver A, Arca-Suarez J. Contribution of mutational resistance mechanisms and acquired beta-lactamases to cefiderocol/xeruborbactam susceptibility in Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0104825. doi: 10.1128/aac.01048-25. Epub 2025 Oct 21.
PubMed 41118352
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06547554
- Acronym / sponsor ID
- QPEX-400
- Conditions
- Bacterial Infections
- Keywords
- beta-lactamase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc., Biomedical Advanced Research and Development Authority
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Randomized, Double-Blind, Controlled, Crossover, Ascending Single Dose Design and Randomized, Double-Blind, Controlled, Multiple Dose Design
| Arm | Type | Receives |
|---|---|---|
| Single Dose Cohorts | Experimental | Drug: Xeruborbactam, Drug: Cefiderocol, Drug: Xeruborbactam/CefiderocolAdministered 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 | Experimental | Drug: XeruborbactamAdministered multiple fixed doses of Xeruborbactam |
| Multiple Dose Cohort Cefiderocol | Experimental | Drug: CefiderocolAdministered multiple fixed doses of Cefiderocol |
| Multiple Dose Cohort Cefiderocol and Xeruborbactam | Experimental | Drug: Xeruborbactam/CefiderocolAdministered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam. |
| Multiple Dose Cohort Placebo | Placebo comparator | Drug: Dextrose 5% in waterAdministered multiple fixed volumes of a placebo comparator |
| Single Dose Cohorts Placebo | Placebo comparator | Drug: Dextrose 5% in waterAdministered single fixed volume of a placebo comparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XeruborbactamAlso: QPX7728Experimental | Drug | Multiple Dose Cohort Xeruborbactam, Single Dose Cohorts |
| CefiderocolExperimental | Drug | Multiple Dose Cohort Cefiderocol, Single Dose Cohorts |
| Xeruborbactam/CefiderocolA combination of Xeruborbactam and Cefiderocol. | Drug | Multiple Dose Cohort Cefiderocol and Xeruborbactam, Single Dose Cohorts |
| Dextrose 5% in waterPlacebo | Drug | Multiple Dose Cohort Placebo, Single Dose Cohorts Placebo |
Primary outcome
The incidence and nature of treatment emergent adverse events (TEAE)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Number of patients with changes from baseline in safety parameters
Time frame: up to day 17 or up to day 21
Summarized by cohort
Maximum plasma concentration (Cmax)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Time to maximum plasma concentration (Tmax)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Area under the plasma concentration versus time curve (AUC)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Terminal elimination half-life (t1/2,z)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Terminal elimination rate constant (λz)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Total clearance (CL)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Renal clearance (CLR)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Fraction of dose excreted in urine (Feu)
Time frame: up to day 17 or up to day 21
Summarized by cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 41118352Gonzalez-Pinto L, Gomis-Font MA, Perez-Rodriguez G, Blanco-Martin T, Rodriguez-Pallares S, Sanchez-Pena L, Beceiro A, Bou G, Jeannot K, Oliver A, Arca-Suarez J. Contribution of mutational resistance mechanisms and acquired beta-lactamases to cefiderocol/xeruborbactam susceptibility in Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0104825. doi: 10.1128/aac.01048-25. Epub 2025 Oct 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xeruborbactam, Cefiderocol and Xeruborbactam/Cefiderocol in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and nature of treatment emergent adverse events (TEAE) (time frame: up to day 17 or up to day 21). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.