New antibiotic combo tested for lung penetration in healthy volunteers
NCT ID NCT06916156
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested whether a combination of two antibiotics, ANT3310 and meropenem, can reach the fluid lining the lungs after being given through an IV. Twenty-six healthy adults received three doses over 24 hours, and a lung wash (bronchoscopy) was used to measure drug levels. The goal was to understand how much of the drug gets into the lungs, which is important for treating serious lung infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ANT3310 and meropenem (antibiotic combination)
- What this could lead to
- If successful, this could help design better dosing for lung infections, potentially improving treatment of serious bacterial pneumonia.
- What could go wrong
- This is a very early Phase 1 study in only 26 healthy volunteers, not patients. It only measures drug levels, not whether the combination actually fights infection. Side effects are possible.
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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26 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Aug 2025
- 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 55 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: * Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol. * Participants must be 18 to 55 years of age, both inclusive, at the time of signing the informed consent. * Body mass index (BMI) within the range 18.0-32.0 kg/m2 (both inclusive) and body weight \> 50.0 kg (110 Ibs) at Screening. * Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Healthy participants as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, 12-lead ECG, vital signs, physical examination, spirometry at Screening (FEV1 \> 80% of predicted), and clinical laboratory tests at Screening and Day -1. * Healthy participants with vital signs at Screening and Day -1 within the normal ranges: tympanic body temperature: ≥ 35.5°C and ≤ 37.5°C; resting pulse rate ≥ 50 beats per minute (bpm) and ≤ 100 bpm; systolic blood pressure (SBP) ≥ 90 and ≤ 139 mmHg, diastolic blood pressure (DBP) ≥ 50 and ≤ 89 mmHg, taken in supine position after resting at least 5 minutes. On Day -1, blood pressure and pulse rate need to be within the normal ranges or not clinically significant range, as per investigator's judgement. * Individualized estimated glomerular filtration rate (eGFR): \[(CKD-EPI ÷ 1.73) × BSA\] ≥ 90 mL/min and \< 160 mL/min for males or \< 150 mL/min for females at Screening. * Sufficient venous access for i.v. infusion and PK samplings. Exclusion Criteria: * History of any clinically relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, hematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer (may have had basal or squamous cell carcinoma of skin or cervix so long as surgically removed or deemed cured by cryotherapy, laser therapy, conization, etc, with stability for the past two years). * History or presence of chronic pulmonary disease. * Medical disorder, condition, or history of such that would - in the opinion of the Investigator - compromise the participant's ability to participate in this study. * Presence of any acute illness, including febrile illness with temperature \> 37.8°C (\> 100.0°F), within 7 days of Baseline (Day -1 to Day 1). * Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction. * Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution. * Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (i.e., penicillin, cephalosporin, carbapenem, or monobactam). * History of significant bleeding within the past 3 months. * History of COVID-19 within three (3) months prior to Screening. * History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders. * History of Gilbert syndrome. * History of any severe antibiotic-associated superinfections, such as Clostridium difficile colitis and/or frequent fungal vaginal infections. * Contraindications to bronchoalveolar lavage or suspected intolerability to medications necessary for bronchoscopy, hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations. Anatomical or anticipated technical difficulties that would prevent bronchoscopy or BAL procedure. Allergies to lidocaine.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, 85032, United States