| Eligibility |
Inclusion Criteria:
1. Provide a signed and dated written informed consent and agrees to comply with the
study procedures and length of confinement to the research site.
2. Be able to understand and willing to comply with study procedures, restrictions, and
requirements, as determined by the Site Principal Investigator (PI) or authorized
clinician(s) (listed on FDA Form 1572).
3. Adults 18 to 45 years of age inclusive, including non-pregnant, non-lactating females.
4. Have suitable veins for cannulation or repeated venipuncture.
5. Be in good general health at the time of enrollment. Note 1: Determined by medical
history (MH), medication use, physical examination (PE), vital signs (VS), clinical
laboratory tests including estimated creatinine clearance (CLCR) > / = 80 mL/min by
the Cockcroft-Gault method, and 12-lead Electrocardiogram (ECG) within reference
ranges at Screening and Day-1.
Note 2: Exceptions to Blood Pressure (BP), Heart Rate (HR) and laboratory test values
being with normal ranges are:
- Subjects with baseline HR > / = 45 to 50 Beats per Minute (bpm) may be accepted
if otherwise healthy adults with known history of asymptomatic bradycardia.
- Subjects with baseline Systolic Blood Pressure (SBP) up to 140 Millimeters of
Mercury (mmHg) and Diastolic Blood Pressure (DBP) up to 90 mmHg may be accepted
if otherwise healthy.
- A laboratory value that is Grade 1 will be allowed if not considered to be
clinically significant by the investigator, with the exception of Alanine
Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase
(AP), total and direct bilirubin, Blood Urea Nitrogen (BUN), serum creatinine,
Creatinine Clearance (CLcr), and urine protein.
6. Sexually active females must be of non-childbearing potential or must use a highly
effective method of birth control from screening to 30 days following the last dose of
study product.
Note 1: A female is considered of childbearing potential unless post-menopausal
(defined as history of > / = 1 year of spontaneous amenorrhea and a
Follicle-Stimulating Hormone (FSH) level >40 IU/L), or permanently surgically
sterilized.
Note 2: Highly effective contraceptive methods include: (a) surgical sterilization
methods, such as tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy,
or successful tubal obliteration (e.g., Essure(R)) with documented radiological
confirmation test at least 90 days after the procedure, or (b) long-acting reversible
contraception, such as progestin-releasing subdermal implants, copper intrauterine
devices (IUDs), levonorgestrel-releasing IUDs.
Note 3: A subject who is not sexually active and abstains from sexual intercourse can
be enrolled and abstinence documented.
7. Sexually active males must be vasectomized or agree to use barrier contraception and
not donate sperm from first dose of study product until 30 days following the last
dose.
Note 1: Barrier contraception includes use of condom with spermicide. Note 2: A
subject who is not sexually active and abstains from sexual intercourse can be
enrolled and abstinence documented.
8. Subjects must be willing to avoid excessive physical exercise within 48 h prior to
dosing until discharge from the CTU on Day 8, and 24 h before the last visit (Day 11
+3 days).
9. No history of acute febrile or infectious illness for at least 7 days prior to the
administration of study drug(s).
Exclusion Criteria:
1. Known history of a clinically significant food or drug allergy/hypersensitivity
including known allergy/hypersensitivity to Ertapenem (ERT), any ß-lactam drugs or
other related drugs.
2. Current seasonal allergies with ongoing symptoms for more than a week prior to dosing
requiring glucocorticoids and/or frequent use of antihistamines for treatment.
3. Any history of a chronic condition including renal failure that may increase risk to
subject or interfere with endpoint assessment, or any unstable chronic disease.
Note 1: Unstable chronic disease is defined by need for frequent medical interventions
that lead to a change in medications and/or required hospitalization, surgery or an
invasive procedure or emergency department/urgent care visit, as determined by the
Site PI.
Note 2: Any chronic disease, that has been diagnosed within 90 days of screening is
excluded.
4. History of any psychiatric condition that has required hospitalization in the last 12
months or subject is considered psychologically unstable by the investigator.
5. History of any clinically significant (CS) disease or disorder, medical/surgical
procedure, or trauma within 4 weeks prior to initiation of administration of study
product(s).
6. History of Clostridium difficile induced diarrhea within 1 year before screening
7. Known history of past or current epilepsy or seizure disorders, excluding febrile
seizures of childhood.
8. Prior exposure to Zidebactam (ZID).
9. Use of any prohibited prescription or non-prescription medication within 14 days prior
to the first dose of study drug(s) as described in Section 6.6
10. Use of any investigational drug product within 30 days or 5 half-lives (whichever is
longer) before investigational product administration in this study.
11. Planned participation in a clinical research study that requires treatment with a
study drug, blood draws or other invasive assessments during the study period
(screening until final visit).
12. Blood or plasma donation of 500 mL within 3 months or more than 100 mL within 30 days
before signing informed consent or planned donation prior to completion of this trial.
13. Positive serum pregnancy test for women at screening and urine pregnancy test at
check-in.
14. Positive urine alcohol test or urine drug screen test at screening or check-in (Day
-1).
15. Positive test for HIV antibodies, hepatitis B-virus surface antigen (HBsAg), or
anti-hepatitis C-virus antibodies (anti-HCV) at screening.
16. History of > / = 10 pack-years smoking in the 5-year period before screening, or
positive urine cotinine screen at check-in.
Note 1: Nicotine products include cigarettes, e-cigarettes, pipe, cigar, chewing
tobacco, nicotine patch.
Note 2: Positive urine cotinine at screening is allowed if negative at check-in (Day
-1).
17. History of binge drinking or heavy drinking of alcohol at any time in the 6 months
before study product administration.
Note 1: Binge drinking is defined as 5 or more drinks during single occasion if male, or 4
or more if female.
Note 2: Heavy drinking of alcohol is defined as consumption of more than 15 units of
alcohol per week if male, or more than 8 units if female.
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