MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: 3 g or 6 g Zidebactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02674347

W-5107-102

Details and patient eligibility

About

Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

Full description

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.

Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.

Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
2. Medical history without any major pathology/surgery in the last 6 months prior to screening.
3. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
4. Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
5. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

Exclusion criteria

1. History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
2. History of Clostridium difficile induced diarrhea or infection within 1 year before screening
3. Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
4. History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

21 participants in 2 patient groups, including a placebo group

Cohort 1: 3 g or 6 g of Zidebactam

Experimental group

Description:

Cohort 1 (Zidebactam): 3 g of Zidebactam (1 g every 8 hours \[q8h\]) (n=8) IV infusions administered over 60 minutes. Cohort 2 (Zidebactam or placebo): 6 g of Zidebactam (2 g q8h) (n=8) IV infusions administered over 60 minutes.

Treatment:

Drug: 3 g or 6 g Zidebactam

Placebo

Placebo Comparator group

Description:

Cohort 1: Placebo every 8 hours \[q8h\] (n=2) IV infusions administered over 60 minutes. Cohort 2: Placebo every q8h (n=2) IV infusions administered over 60 minutes.

Treatment:

Drug: Placebo