Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin

Exclusion Criteria

• •History of clinically significant psychiatric disorder within the past 5 years.
• •History of stroke, chronic seizures, or other major neurological disorder.
• •History or evidence of drug/alcohol abuse within 1 year prior to Screening.
• •History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or disease.
• •History of cancer (malignancy).
• •History of any illness that, in the opinion of the study investigator, may confound the results of the study or pose additional risk to the subject if he participates in the study.
• •Administration of another investigational medication within 30 days (or 5 half lives, whichever is longer) prior to study drug administration.
• •Participation in an investigational device study within 30 days prior to study drug administration.
• •Excessive consumption of alcohol, defined as \>3 alcoholic beverages per day (10 ounces of beer \[284 mL\], 4 ounces of wine \[125 mL\], or 1 ounce of distilled spirits \[25 mL\] is approximately equivalent to 1 alcoholic beverage)
• •Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive consumption is defined as \>6 servings per day (1 serving contains approximately 120 mg caffeine)
• •History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks of Torsade de Pointes or sudden premature death.
• •Any ECG abnormality considered to be clinically significant by the principal investigator (PI)/designee;
• •Glomerular filtration rate (GFR) ≤80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation.
• •Ongoing liver disease or unexplained liver function test (LFT) elevations
• •History of hypersensitivity to β lactam antibiotics (including, but not limited to imipenem)
• •History of significant multiple and/or severe allergies (including latex allergy);
• •Loss or donation of blood (approximately 500 mL) within 60 days prior to study drug administration on Day 1, or donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1.
• •History of infectious disease within 28 days prior to study drug administration on Day 1 that, in the opinion of the investigator, would affect the subject's ability to participate in the trial.
• •Venous access considered inadequate for PK sample collection and IV infusion; history or evidence of adverse symptoms associated with IV access, phlebotomy, or blood donation.
• •Employee or family member of the investigator, study site personnel, or sponsor.
• •Any other clinically relevant abnormality in the opinion of the investigators from the following: medical and/or surgical history, physical examination, vital signs, 12-lead ECG, serum chemistry, hematology, and urinalysis.
• •Any other reason that, in the opinion of the investigator, would render the subject unsuitable for study enrollment.