Safety and blood-level testing of an oral fixed-dose combo of ceftibuten and ledaborbactam etzadroxil
Official title: A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil
Run by Basilea Pharmaceutica · NCT06733675 · Data updated 2026-11-12
This will test the safety and how the body processes an oral fixed-dose combination of ceftibuten and ledaborbactam etzadroxil in healthy adults aged 18–55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Basilea Pharmaceutica Industry-sponsored |
| Locations | 1 site (Lenexa, Kansas) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06733675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 with BMI 18–32 kg/m2, normal screening labs, who are not pregnant or breastfeeding and have no history of β-lactam allergy or recent substance use are ideal candidates.
✕Probably not a fit
People with a known allergy to cephalosporins or penicillins, pregnant or lactating individuals, those with recent acute illness or abnormal screening labs, and those who use tobacco, drugs, or alcohol will not benefit or may be ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, open-label, two-part trial enrolling about 46 healthy adults to characterize safety and pharmacokinetics of a fixed-dose oral combination of ceftibuten and ledaborbactam etzadroxil. Parts 1 and 2 may run in parallel, with at least 16 participants in Part 1 and up to 30 in Part 2, and some participants evaluated for drug–drug interaction with esomeprazole. Participants are screened within 28 days prior to dosing, admitted to the clinical research unit the day before dosing, remain on-site through the PK sample collection period, and return for a follow-up visit about 7 days after the last dose. Individual participation lasts approximately 43–46 days depending on the part.
Why it matters
Potential benefit: If successful, this could enable a convenient oral antibiotic combination that helps overcome certain resistance mechanisms and expand outpatient treatment options.
How similar studies have gone: Some cephalosporin plus beta-lactamase inhibitor combinations have shown promise in development, but ledaborbactam etzadroxil paired orally with ceftibuten is relatively novel and remains early-stage.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
ICON, Clinical Research Phase I Unit
Lenexa, Kansas, United States Recruiting
Study contacts
- Study coordinator: Karine Litherland, PhD
- Email: Karine.Litherland@basilea.com
- Phone: +41616061111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.