Clinical trial NCT02674347: MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2016-02-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings.
timeFrame: 14 days
measure: Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results
timeFrame: 14 days
Secondary outcomes:
measure: Pharmacokinetic parameters -maximum plasma concentration will be evaluated.
timeFrame: 7 days
measure: Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated.
timeFrame: 7 days
measure: Pharmacokinetic parameters- terminal half life etc will be evaluated
timeFrame: 7 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles
state: Kansas
Study officials:
References: