New antibiotic combo tested in healthy volunteers – no cure yet
NCT ID NCT06733675
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This early-stage study tests a new antibiotic combination (ceftibuten-ledaborbactam) in 46 healthy adults aged 18-55. The goal is to check safety and how the drug moves through the body, not to treat any disease. Participants will stay at a clinic for several days and have follow-up visits. This research helps gather important safety data before testing in patients.
Why investors are watching
Basilea is running a Phase 1 trial of a fixed-dose combination of two antibiotics, ceftibuten and ledaborbactam etzadroxil, in 96 healthy adults. The study checks safety and how the body processes the drug. For a small company, this early readout matters because it is the first step toward a possible new product, and any safety problem could set the program back.
If it works: If the drug proves safe and behaves as expected in healthy people, Basilea can move it into later trials. That progress could strengthen the company's pipeline and its position in the antibiotic market.
If it fails: Phase 1 trials often fail or reveal safety issues, and this one is early. A poor result or a delay could hurt the program and the company's prospects, since Basilea depends on a few key drugs.
AI-written from the trial record. Speculative, and not investment advice.
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 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 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 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: * Healthy adult male or female, between 18 and 55 years of age * Body mass index ≥ 18 and ≤ 32 kg/m2 * Laboratory values meeting defined laboratory ranges * Males or non-pregnant, non-lactating females Exclusion Criteria: * History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug * Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant * 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.
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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ICON, Clinical Research Phase I Unit
RECRUITINGLenexa, Kansas, 66219, United States
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