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

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.

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)