PHA1APhase 1NCT06806995
A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
A Phase 1 study testing Zidebactam-Cefepime, Metronidazole and FEP-ZID in people with PHA1A, run by Wockhardt at 1 site in United States.
Trial summary
This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- PHA1A
- What is being tested?
- Zidebactam-Cefepime, Metronidazole and FEP-ZID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 17 Feb 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 45 years of age (inclusive)
- Body mass index of 18 to 31 kg/m2 (inclusive).
- Subjects voluntarily consented to participate in this study and who have signed and dated the informed consent form.
- No major pathology/surgery in the 6 months prior to screening Agrees to use effective methods of contraception
- Resting supine blood pressure of 90 to 139 (systolic)/50 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
- Calculated creatinine clearance ≥90 mL/min (Cockcroft-Gault method).
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- Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator. The QT interval corrected for heart rate using Fridericia's formula must be ≤450 ms for males and be ≤460 ms for females.
- Males must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom and highly effective method of contraception (see Section 6.6) until 90 days after the last administration of study drug.
- Females should not be pregnant or breastfeeding (to be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or should be of non-childbearing potential at screening.
- Females must be either postmenopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing one of the acceptable methods of birth control, as defined in inclusion criteria #7, for 3 weeks prior to study drug administration, during the study, and for 90 days after the last administration of study drug.
- All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from the normal range as judged by the Principal Investigator.
Who cannot join
- Participation in another investigational drug or device study or treated with a study drug within 30 days or 5 half-lives, whichever is longer, before receiving any study drug in this study.
- 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.
- History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or metronidazole or any other related drugs.
- History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
- Prior exposure to zidebactam.
- Consumed more than 28 units of alcohol per week at any time in the 6 months before study drug administration (1 unit of alcohol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of active alcoholism and/or drug/chemical abuse within the last 3 to 5 years.
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- A positive screen result for drugs of abuse/alcohol at admission to the study center at Check-in.
- Use of prescription medications (with the exception of oral contraceptives, all forms of hormonal contraceptives, and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations within 14 days or 5 half-lives (whichever is longer) before study drug administration, or use of over-the-counter medication, acetaminophen (>500 mg/day), vitamins, or supplements (including fish liver oils) within 7 days before the first administration of study drug. Acetaminophen ≤500 mg/day is allowable 3 days before enrollment in the study (Day 1). Should the subject have taken any other medications the Investigator will discuss enrolling the subject with the medical monitor on a case-by-case basis.
- Positive serology test for hepatitis B surface antigen, hepatitis C virus or human immunodeficiency virus I/II at screening.
- Any strenuous activity within 96 hours (4 days) prior to enrollment in the study. Strenuous is defined as any hard labor or exercise outside of a subject's usual behavior.
- Unable or unwilling to stay in the study center for the required duration as per the protocol or consume the standard meal provided by the study center.
- History of blood donation of more than 500 mL in the last 2 months prior to screening.
- Consumption of methylxanthine-containing food or beverages (such as coffee, tea, cola, chocolate, 'power drinks'), grapefruit or grapefruit juice, or Seville oranges or products containing Seville oranges for 48 hours prior to enrollment in the study and while resident at the study center.
- Current use or has used tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) 30 days prior to study drug administration. A cotinine test (with a cut-off of 200 mg) will be performed at screening and at Check-In (Day -1).
- Subject has a history of difficulty in providing blood samples or has poor veins which may cause difficulty in obtaining blood samples during the study.
- History of bleeding disorders.
- Unable or unwilling to follow study instruction or restrictions or a history of the same.
- Any other medical, psychological, or social condition which, in the opinion of the Principal Investigator would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern for the subject.
- Any person who is an employee of the Principal Investigator or study center with direct involvement in this proposed study or any other study under the direction of the Principal Investigator or the study center or who is directly involved in the planning and/or conduct of the study, as well as relatives of the employee, the Investigators, or the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination Utilizing a 3-Period, Crossover Study Design
This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.
- Conditions
- PHA1A
- Being tested
- Zidebactam-Cefepime, Metronidazole, FEP-ZID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zidebactam-CefepimeDrug
(1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h)
MetronidazoleDrug
(2) metronidazole 0.5 g IV alone administered over 1 h
FEP-ZIDDrug
(3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.
| Study group | Role | What they receive |
|---|---|---|
| Zidebactam Cefepime | Experimental | Zidebactam Cefepime 3gm Vial Receives: Drug: Zidebactam-Cefepime; Drug: Metronidazole; Drug: FEP-ZID |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess Plasma Pharmacokinetics Parameters
Maximum concentration (Cmax)
Measured: Day 1, 4, 7
To assess Plasma Pharmacokinetics Parameters
Area under the concentration time curve up to infinity (AUC0-inf) for each analyte
Measured: Day 1, 4, 7
Secondary outcomes (5)
To Assess Plasma Pharmacokinetics Parameters Area Under Concentration
Area Under Concentration Time curve up to last measurable time point (AUClast)
Measured: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Time to reach maximum concentration
Time to reach maximum concentration (Tmax)
Measured: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Terminal elimination half-life
Terminal elimination half-life (T½)
Measured: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Plasma Clearance
Plasma Clearance (CL)
Measured: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Volume of Distribution
Volume of Distribution (Vz)
Measured: Day 1, 4, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start21 Jan 2025
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHA1AStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eric Solutions LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806995
- Sponsor's protocol ID
- W-5222-106
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination Utilizing a 3-Period, Crossover Study Design
- ClinicalTrials.gov ID
- NCT06806995
- Acronym / sponsor ID
- W-5222-106
- Conditions
- PHA1A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Eric Solutions LLC
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 4 Feb 2025 (actual)
- 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.
This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zidebactam Cefepime | Experimental | Drug: Zidebactam-Cefepime, Drug: Metronidazole, Drug: FEP-ZIDZidebactam Cefepime 3gm Vial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, 18 to 45 years of age (inclusive)
- Body mass index of 18 to 31 kg/m2 (inclusive).
- Subjects voluntarily consented to participate in this study and who have signed and dated the informed consent form.
- No major pathology/surgery in the 6 months prior to screening Agrees to use effective methods of contraception
- Resting supine blood pressure of 90 to 139 (systolic)/50 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
Key exclusion criteria (19 listed)
- Participation in another investigational drug or device study or treated with a study drug within 30 days or 5 half-lives, whichever is longer, before receiving any study drug in this study.
- 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.
- History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or metronidazole or any other related drugs.
- History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
- Prior exposure to zidebactam.
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 |
|---|---|---|
| Zidebactam-Cefepime(1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h) | Drug | Zidebactam Cefepime |
| Metronidazole(2) metronidazole 0.5 g IV alone administered over 1 h | Drug | Zidebactam Cefepime |
| FEP-ZID(3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period. | Drug | Zidebactam Cefepime |
Primary outcome
To assess Plasma Pharmacokinetics Parameters
Time frame: Day 1, 4, 7
Maximum concentration (Cmax)
To assess Plasma Pharmacokinetics Parameters
Time frame: Day 1, 4, 7
Area under the concentration time curve up to infinity (AUC0-inf) for each analyte
5 secondary outcomes
To Assess Plasma Pharmacokinetics Parameters Area Under Concentration
Time frame: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Time to reach maximum concentration
Time frame: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Terminal elimination half-life
Time frame: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Plasma Clearance
Time frame: Day 1, 4, 7
To Assess Plasma Pharmacokinetics Parameters Volume of Distribution
Time frame: Day 1, 4, 7
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 16 Sep 2025.
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 Zidebactam-Cefepime, Metronidazole and FEP-ZID in people with PHA1A, 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 11 inclusion and 19 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 16 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. 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?
To assess Plasma Pharmacokinetics Parameters (time frame: Day 1, 4, 7). 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 16 Sep 2025.