Antibiotic lung penetration study launches in china
NCT ID NCT07124468
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial in 16 healthy adults in China measures how much of the intravenous antibiotic Meropenem-Pralubactam gets into lung fluids and cells. Researchers aim to find the drug's concentration in plasma, epithelial lining fluid, and alveolar macrophages after four doses. The study does not treat any infection but provides key data for future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Meropenem-Pralubactam (an antibiotic combination given intravenously)
- What this could lead to
- If successful, this study could help doctors understand the right dose of this antibiotic to treat lung infections.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only measures drug levels, not whether the drug works against infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, aged 18-45 years * Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg. * Pulmonary function at screening: 1. Forced expiratory volume in 1 second (FEV₁) measured/predicted \>80% 2. Forced vital capacity (FVC) measured/predicted \>80% 3. All other ventilation and diffusion parameters normal or with no clinical significance. * Participant capability: 1. Ability to communicate effectively with investigators 2. Willingness to comply with study procedures 3. Voluntary participation with acceptance of bronchoalveolar lavage (BAL) 4. Provision of written informed consent. * Reproductive planning: 1. No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose 2. Participant and partner must use protocol-approved contraception. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Fujian Medical University
RECRUITINGFuzhou, China
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