PHA1APhase 1NCT03630094
Plasma and Intrapulmonary Concentrations Study of WCK 5222
A Phase 1 study testing FEP-ZID in people with PHA1A, run by Wockhardt at 1 site in United States.
Trial summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PHA1A
- What is being tested?
- FEP-ZID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 30 Jul 2017
- 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
- Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
- Medical history without any major pathology as judged by the Investigator.
- Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Who cannot join
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Current use or has used tobacco or nicotine containing products 6 month prior to screening.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- History or presence of alcohol or drug abuse within the 2 years prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
- Conditions
- PHA1A
- Being tested
- FEP-ZID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEP-ZIDDrug
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
| Study group | Role | What they receive |
|---|---|---|
| FEP-ZID via intravenous | Experimental | total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen Receives: Drug: FEP-ZID |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
Measured: Day 3
concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)
Measured: Day 3
Secondary outcomes (2)
Number of adverse event reported
Measured: Day 3
number variation noted in 12-lead electrocardiogram
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start31 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Jul 2017
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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630094
- Sponsor's protocol ID
- W-5222-104
- Status last verified
- Aug 2018
- First submitted
- 17 Mar 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT03630094
- Acronym / sponsor ID
- W-5222-104
- Conditions
- PHA1A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 14 Aug 2018 (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 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEP-ZID via intravenous | Experimental | Drug: FEP-ZIDtotal of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
- Medical history without any major pathology as judged by the Investigator.
- Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Key exclusion criteria (5 listed)
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Current use or has used tobacco or nicotine containing products 6 month prior to screening.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- History or presence of alcohol or drug abuse within the 2 years prior to screening.
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 |
|---|---|---|
| FEP-ZIDA total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen | Drug | FEP-ZID via intravenous |
Primary outcome
concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
Time frame: Day 3
concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)
Time frame: Day 3
2 secondary outcomes
Number of adverse event reported
Time frame: Day 3
number variation noted in 12-lead electrocardiogram
Time frame: Day 3
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 14 Aug 2018.
- Individual participant dataSharing planned: No
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 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 3 inclusion and 5 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 14 Aug 2018. 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?
concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF) (time frame: Day 3). 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 14 Aug 2018.