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

Launched by QPEX BIOPHARMA, INC. · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two medications, cefiderocol and xeruborbactam, when taken together. Both of these drugs are designed to treat bacterial infections, but the researchers want to understand how they interact with each other in healthy adults. This is a Phase 1 trial, which means it's one of the first steps in testing these medications in people. The study is currently looking for volunteers aged 18 to 55 who are generally in good health, without serious medical conditions or a history of drug abuse.

Participants in this trial will receive either the combination of the two drugs or a placebo (a harmless pill with no active ingredients) without knowing which one they got. Throughout the study, participants will have regular check-ups to monitor their health and how their bodies respond to the medications. It’s important to note that individuals with a history of serious allergies to similar medications or certain health conditions won't be eligible to participate. If you or someone you know is interested in this study, it could be a chance to help researchers learn more about these drugs and their potential benefits for treating infections.

Gender

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Eligibility 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)