Investigating the safety and pharmacokinetics of cefiderocol with xeruborbactam in healthy adults
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
PHASE1 · Qpex Biopharma, Inc. · NCT06547554
This study is testing how safe and effective a new combination of two antibiotics, cefiderocol and xeruborbactam, is in healthy adults to see if it can help fight bacterial infections.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Qpex Biopharma, Inc. (industry) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06547554 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial is designed to evaluate the pharmacokinetics and safety of cefiderocol when combined with xeruborbactam in healthy adult participants. The study employs a randomized, double-blind, placebo-controlled methodology to ensure robust data collection and analysis. Participants will receive either the drug combination or a placebo, and their health will be monitored closely throughout the trial. The goal is to assess how these two drugs interact and their potential effectiveness against bacterial infections.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18.5 and 32.
Not a fit: Patients with significant underlying health conditions or those with a history of severe allergic reactions to beta-lactam antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for bacterial infections, particularly those resistant to current antibiotics.
How similar studies have performed: While this approach is novel in combining cefiderocol with xeruborbactam, similar studies have shown promise in evaluating drug interactions and enhancing antibiotic efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Minneapolis, Minnesota
- Minneapolis Clinic — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Jeff Loutit, MBChB
- Email: jloutit@qpexbio.com
- Phone: 6509468505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bacterial Infections, beta-lactamase inhibitor