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Bacterial InfectionsPhase 1NCT07104162

A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

A Phase 1 study testing Cefiderocol/Xeruborbactam in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Bacterial Infections
What is being tested?
Cefiderocol/Xeruborbactam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
16 Sep 2025to 4 Sep 2026
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • An individual will be eligible to be included in the study only if all of the following criteria apply:
  • All participants
  • Able to understand the study conduct and tasks required of the participants, sign the informed consent form and willing to cooperate with all tests and examinations required by the protocol.
  • Aged 18 to 80 years, inclusive, at the time of consent.
  • If male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
  • If female of childbearing potential, must either be sexually abstinent for 14 days prior to Day -1 and remain so through 30 days following dosing of the study intervention or have been using (or agree to use) 2 acceptable methods of birth control when engaging in heterosexual activity
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  • If female of childbearing potential, must agree not to donate eggs (ova, oocytes) for the purpose of reproduction from Day -1 through 30 days following the last administration of the study intervention.
  • If female of non-childbearing potential, must either be postmenopausal (defined as 12 months spontaneous amenorrhea) with serum follicle stimulating hormone (FSH) level in the laboratory-defined postmenopausal range or have undergone sterilization procedures at least 6 months prior to Day -1; documentation of sterilization procedure must be obtained
  • Has a BMI ≥ 18.5 kg/m2 and ≤ 45 kg/m2, inclusive.
  • Has negative test results for hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, and SARS-CoV-2.
  • Participants with normal renal function:
  • Has an eGFR ≥ 90 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
  • Meets matching criteria for age, BMI, and gender of pooled renally impaired participants as defined in the protocol.
  • Participants with renal impairment
  • Stable mild to severe renal impairment, as assessed by eGFR calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
  • Is on a stable medication regimen
  • Participants with ESRD on hemodialysis
  • Receiving stable IHD at least 3 times a week for at least 3 months, using an arteriovenous fistula, graft, or catheter
  • Is on a stable medication regimen

Who cannot join

  • An individual must not meet any of the following exclusion criteria to be eligible to participate in the study:
  • Has unstable or new medical condition(s)
  • Has had surgery under general anesthesia within the past 3 months prior to Day -1, determined by the investigator to be clinically relevant.
  • Documented hypersensitivity reaction or anaphylaxis to any medication.
  • History of seizures, convulsions
  • Current evidence or history of malignancy
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  • If female, is pregnant, lactating, or has a positive pregnancy test at screening or Day -1.
  • Received any investigational drug within 30 days or 5 half-lives, whichever is longer, of Day -1 for the current clinical study.
  • Blood donation or significant blood loss (ie, > 500 mL) within 56 days prior to Day -1.
  • Plasma or platelet donation within 14 days prior to Day -1.
  • Any acute illness requiring antibiotic drug therapy within 30 days prior to Day -1 or a febrile illness within 7 days prior to Day -1.
  • Vigorous exercise from 72 hours prior to Day -1 through the final FU/EOS Visit.
  • Positive drug test at the Screening Visit or Day -1
  • Positive alcohol test at screening or Day -1 and/or recent history (ie, within 6 months prior to Day -1) of excessive alcohol intake.
  • Concurrent use of medications known to affect the elimination of serum creatinine and competitors of renal tubular secretion
  • Employees of the investigative site involved in this study.
  • Unable or unwilling to adhere to the study-specified procedures and restrictions.
  • QTcF interval > 500 msec, previous history or family history of prolonged QT syndrome at screening or Day -1.
  • Use of products containing alcohol, caffeine, xanthine, or ephedrine within 24 hours prior to Day -1; use of alcohol 48 hours prior to Day -1; use of proton pump inhibitors (eg, omeprazole and pantoprazole) 7 days prior to Day -1, including both over-the-counter (OTC) and prescription drugs in these categories; or consumption of grapefruit/grapefruit juice, Seville oranges, pomelo, exotic citrus fruits or grapefruit hybrids or juices containing such products within 7 days prior to Day -1.
  • Has any clinically significant abnormalities in laboratory values at screening or Day -1, defined in the study protocol.
  • Participants with normal renal function:
  • Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion.
  • Participants with renal impairment, including those on IHD:
  • Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion. Participants in the renal impairment group will have consideration for the degree of renal impairment and presence of comorbidities.
  • Has renal disease secondary to hepatic disease (hepatorenal syndrome)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Miami Clinical Pharmacology

    Miami, Florida, 33136

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants With Renal Impairment

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment

Read the detailed description

Qpex Biopharma, Inc., a wholly owned subsidiary of Shionogi Inc., is developing a fixed combination antibiotic of cefiderocol, a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis, and hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), plus an investigational broad-spectrum beta-lactamase inhibitor (BLI), xeruborbactam (QPX7728) to address the need for new antibiotics for the pathogens deemed as urgent or critical threats.

The aim of this study is to compare single-dose intravenous (IV) pharmacokinetics (PK) and safety of the combination of cefiderocol/xeruborbactam (S-649228) in participants with various degrees of stable renal impairment, including those with end-stage renal disease (ESRD), to control participants with normal renal function.

The results from this study will enable the development of appropriate dosing recommendations in patients with impaired renal function.

Objectives:

The objectives of the study are:

  1. To assess the impact of mild, moderate, and severe renal impairment, and intermittent hemodialysis (IHD) on the PK of IV cefiderocol and IV xeruborbactam given to participants with stable renal impairment, normal renal function, and ESRD receiving IHD therapy.
  2. To evaluate the safety and tolerability of IV cefiderocol and IV xeruborbactam given to participants with stable renal impairment, normal renal function, and ESRD receiving IHD therapy.
Being tested
Cefiderocol/Xeruborbactam
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.

  • Cefiderocol/XeruborbactamDrug

    Also called Cefiderocol/QPX7728, S-649228

    A fixed dose combination of intravenous cefiderocol and intravenous xeruborbactam

Study groups in NCT07104162
Study groupRoleWhat they receive
Open Label, Single Dose of IV Cefiderocol/XeruborbactamExperimentalApproximately 40 participants will be enrolled in total. Eight participants will be enrolled in each group (G) based on renal impairment (RI) determined by estimated glomerular function rate (eGFR) or need for intermittent hemodialysis (IHD) at screening: * G1: Mild RI (eGFR 60 < 90 mL/min calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration equation [CKP-EPI]) adjusted for the participant's body surface [BSA]) * G2: Moderate RI (eGFR 30 to < 60 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA) * G3: Severe RI (eGFR < 30 mL/min calculated using the 2021 CKD-EPI equation) not receiving IHD therapy * G4: Healthy participants with normal renal function matched to participants in Groups 1 and 2 (Group 3 may be included) based on age, gender and body mass index (BMI) * G5: Participants with end stage renal disease (ESRD) receiving IHD All participants will receive a single dose of cefiderocol/xeruborbactam on Day 1.
Receives: Drug: Cefiderocol/Xeruborbactam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs) by participant and by group

    Number of participants with treatment-emergent adverse events by severity and relationship to treatment

    Measured: 11-22 days (+/- 2)

  2. Number of participants with changes from baseline in safety parameters

    Number of participants with changes in safety parameters before and after dosing by subject and group

    Measured: 11-22 days (+/- 2)

  3. Maximum plasma concentration measurements by subject and by group (Cmax)

    Comparison will be performed between the groups for maximum plasma concentration (Cmax).

    Measured: 11-22 days (+/- 2)

  4. Time to maximum plasma concentration (Tmax)

    Comparison will be performed between the groups for time to maximum plasma concentration (Tmax)

    Measured: 11-22 days (+/- 2)

  5. Area under the plasma concentration versus time curve (AUC)

    Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC)

    Measured: 11-22 days (+/- 2)

  6. Cumulative amount of drug excreted as unchanged in the urine (Aeu)

    This parameter will not be estimated in Group 5

    Measured: 11-22 days (+/- 2)

  7. Cumulative amount of drug excreted as unchanged in the dialysate (Aed)

    This parameter will be estimated only in Group 5. Urine pharmacokinetic (PK) parameters will be calculated from urinary excretion and dialysate data.

    Measured: 11-22 days (+/- 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start16 Sep 2025
  3. Primary completion4 Sep 2026
  4. Study completion4 Sep 2026

Resources

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
Not applicable
Intervention model
Sequential
Model description
Open-label, single-dose
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07104162
Sponsor's protocol ID
Qpex-401
Status last verified
Sep 2026
First submitted
29 Jul 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cefiderocol/Xeruborbactam in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites 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 19 inclusion and 25 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Incidence of treatment-emergent adverse events (TEAEs) by participant and by group (time frame: 11-22 days (+/- 2)). The study lists 7 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 NCT07104162.

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 25 Sep 2026.

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