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Antibiotic lung penetration study launches in china

NCT ID NCT07124468

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, China

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Other studies related to the condition(s) this trial covers.