| Eligibility |
Inclusion Criteria:
- Healthy male adults aged 18-65 years
- Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
- In good general health, as determined by the Investigator, based on medical history,
physical examination, 12 lead electrocardiogram (ECG), vital sign (VS) measurements,
and laboratory test results.
- Normal blood pressure (BP), defined as: systolic BP (SBP) =90 mmHg and =140 mmHg; and
diastolic BP (DBP) <90 mmHg at the time of Screening
- Male subjects with female partners of reproductive potential must agree to practice
abstinence or to use a condom (male subject) in addition to an acceptable method
(female partner) of contraception for the duration of the study and for at least 90
days post last dose.
- Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C
antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E
immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody
chemiluminescent immunoassay (TP IA).
- Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C
antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E
immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody
chemiluminescent immunoassay (TP IA).
- Non smoker (with no use of other tobacco or nicotine containing products, in any
form), as documented by history (no nicotine within 3 months prior to Screening)
- Negative results for drugs of abuse, alcohol, and cotinine at Screening and Admission
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 ß 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.
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