Healthy SubjectsPhase 1NCT02674347
MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults
A Phase 1 study testing 3 g or 6 g Zidebactam in people with Healthy Subjects, run by Wockhardt at 1 site in United States.
Trial summary
Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 3 g or 6 g Zidebactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
- Medical history without any major pathology/surgery in the last 6 months prior to screening.
- All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
- 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.
- Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
- Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
Who cannot join
- History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
- History of Clostridium difficile induced diarrhea or infection within 1 year before screening
- Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
- 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 locations and contacts
1 site in 1 country.
About this study
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 to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- 3 g or 6 g Zidebactam, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 g or 6 g ZidebactamDrug
Also called WCK 5107
IV for over a duration of 60 minutes
PlaceboDrug
IV matching the Investigational drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 3 g or 6 g of Zidebactam | Experimental | 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. Receives: Drug: 3 g or 6 g Zidebactam |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings.
Measured: 14 days
Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results
Measured: 14 days
Secondary outcomes (3)
Pharmacokinetic parameters -maximum plasma concentration will be evaluated.
Measured: 7 days
Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated.
Measured: 7 days
Pharmacokinetic parameters- terminal half life etc will be evaluated
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674347
- Sponsor's protocol ID
- W-5107-102
- Status last verified
- Sep 2025
- First submitted
- 25 Jan 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02674347
- Acronym / sponsor ID
- W-5107-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 3 g or 6 g of Zidebactam | Experimental | Drug: 3 g or 6 g ZidebactamCohort 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. |
| Placebo | Placebo comparator | Drug: PlaceboCohort 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
- Medical history without any major pathology/surgery in the last 6 months prior to screening.
- All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
- 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.
- Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
Key exclusion criteria (4 listed)
- History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
- History of Clostridium difficile induced diarrhea or infection within 1 year before screening
- Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 g or 6 g ZidebactamAlso: WCK 5107IV for over a duration of 60 minutes | Drug | Cohort 1: 3 g or 6 g of Zidebactam |
| PlaceboIV matching the Investigational drug | Drug | Placebo |
Primary outcome
Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings.
Time frame: 14 days
Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results
Time frame: 14 days
3 secondary outcomes
Pharmacokinetic parameters -maximum plasma concentration will be evaluated.
Time frame: 7 days
Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated.
Time frame: 7 days
Pharmacokinetic parameters- terminal half life etc will be evaluated
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3 g or 6 g Zidebactam in people with Healthy Subjects, run by Wockhardt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings. (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.