InfectionsPhase 1NCT07124468
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
A Phase 1 study testing Meropenem-Pralubactam in people with Infections, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Meropenem-Pralubactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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, aged 18-45 years
- Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
- Pulmonary function at screening:
- Forced expiratory volume in 1 second (FEV₁) measured/predicted >80%
- Forced vital capacity (FVC) measured/predicted >80%
- All other ventilation and diffusion parameters normal or with no clinical significance.
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- Participant capability:
- Ability to communicate effectively with investigators
- Willingness to comply with study procedures
- Voluntary participation with acceptance of bronchoalveolar lavage (BAL)
- Provision of written informed consent.
- Reproductive planning:
- No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose
- Participant and partner must use protocol-approved contraception.
Who cannot join
- Hypersensitivity to cephalosporins or carbapenem antibiotics.
- History or current diagnosis of respiratory system diseases.
- History or current diagnosis of coagulation disorders.
- Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems judged by the investigator to interfere with study outcomes.
- History of smoking or positive nicotine test during screening.
- Prior surgery involving pharynx, trachea/bronchi, or lungs.
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- Drug abuse history within 1 year prior to screening or positive urine drug screen at screening.
- Alcohol intake >14 units/week on average within 6 months prior to screening.
- Participation in other clinical trials with investigational drugs/devices within 3 months prior to screening.
- Blood donation/loss ≥400 mL or blood product transfusion within 3 months prior to screening.
- Respiratory infections (bacterial/fungal/viral) within 2 weeks prior to screening (e.g., upper/lower respiratory tract infections).
- Use of any medication/vaccination within 14 days prior to screening or planned vaccination during the study.
- Clinically significant abnormalities in physical examination, 12-lead ECG, or imaging at screening per investigator's judgment.
- Pregnancy, lactation, or positive serum pregnancy test at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Pinfang Huang, bachelor, 0591- 87981331, 2363869908@qq.com
About this study
Official title: A Phase 1, Randomized, Open-Label, Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. The main question it aims to answer is:
- [question 1] : What are the concentrations of meropenem and Pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at each time point
- Conditions
- Infections
- Being tested
- Meropenem-Pralubactam
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem-PralubactamDrug
The study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Meropenem-Pralubactam | Experimental | Not described Receives: Drug: Meropenem-Pralubactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPlasma、CELF、CAM
Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start13 Sep 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124468
- Sponsor's protocol ID
- FL058-Ⅰ-05
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07124468
- Acronym / sponsor ID
- FL058-Ⅰ-05
- Conditions
- Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 15 Aug 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.
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. The main question it aims to answer is:
- [question 1] : What are the concentrations of meropenem and Pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at each time point
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Meropenem-Pralubactam | Experimental | Drug: Meropenem-Pralubactam |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female, aged 18-45 years
- Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
- Pulmonary function at screening:
- Participant capability:
- Reproductive planning:
Key exclusion criteria (14 listed)
- Hypersensitivity to cephalosporins or carbapenem antibiotics.
- History or current diagnosis of respiratory system diseases.
- History or current diagnosis of coagulation disorders.
- Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems judged by the investigator to interfere with study outcomes.
- History of smoking or positive nicotine test during 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 |
|---|---|---|
| Meropenem-PralubactamThe study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam | Drug | Intravenous Meropenem-Pralubactam |
Primary outcome
CPlasma、CELF、CAM
Time frame: 5 days
Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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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.
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 Meropenem-Pralubactam in people with Infections, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 22 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pinfang Huang, bachelor (0591- 87981331, 2363869908@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPlasma、CELF、CAM (time frame: 5 days). 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 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.