New antibiotic combo tested in healthy volunteers
NCT ID NCT06665555
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This completed Phase 1 study tested how two antibiotics, ceftibuten and ledaborbactam, move through the blood and lungs of 34 healthy adults aged 18-55. Participants took five doses of the drugs and underwent a bronchoscopy to measure drug levels in lung fluid. The goal was to understand safety and drug distribution, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ceftibuten and ledaborbactam etzadroxil
- What this could lead to
- If successful, this could help determine the right doses for future studies of this antibiotic combination against lung infections.
- What could go wrong
- This is an early Phase 1 study in healthy volunteers, not patients. It only measures drug levels, not whether the drug works against infections. Results may not predict real-world effectiveness.
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
-
34 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Mar 2025
- 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 55 years
- Sex
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Anyone
- Healthy volunteers
-
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.
Participants must have met the following key criteria to be eligible for enrollment into the study: Inclusion Criteria: * Healthy adults 18-55 years * Males or non-pregnant, non-lactating females * Body Mass Index: ≥18 and ≤32 kg/m2 * Forced expiratory volume in 1 second of at least 80% of predicted value * Laboratory values meeting defined entry criteria Exclusion Criteria: * History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug or to medications used during a bronchoscopy * Conditions that potentially alter absorption and/or excretion of orally administered drugs * History or presence of significant diseases, including any clinically relevant acute illness or surgery within the past 3 months * Positive alcohol, drug, or tobacco use/test
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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
-
Pulmonary Associates
Phoenix, Arizona, 85032, United States
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