New antibiotic cocktail tested for safety in 60 volunteers
NCT ID NCT06547554
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study tested a combination of two antibiotics, cefiderocol and xeruborbactam, in 60 healthy adults. The goal was to see how the drugs interact in the body and whether they are safe. Participants received either the drug combo or a placebo, and researchers monitored side effects and drug levels in blood and urine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cefiderocol and xeruborbactam (antibiotic combination)
- What this could lead to
- If successful, this could help develop a new antibiotic combination for hard-to-treat bacterial infections.
- What could go wrong
- This is a very early Phase 1 study in healthy people, not patients. It only checks safety and how the drugs interact, not whether they work 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
-
60 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
Oct 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
-
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.
Inclusion Criteria: * Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed consent. * Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) * Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile * Voluntary consent to participate in the study. Exclusion Criteria: * History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration * Females who are pregnant or lactating * Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)
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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.
Contacts and locations
Locations
-
Minneapolis Clinic
Minneapolis, Minnesota, 55114, United States
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