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A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants
This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbactam etzadroxil or ceftibuten alone. BAL fluid samples and plasma samples will be collected at designated timepoints to determine the concentrations of ceftibuten, ledaborbactam, and urea.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Pulmonary Associates
Phoenix, Arizona, United States
Start Date
November 4, 2024
Primary Completion Date
March 13, 2025
Completion Date
March 17, 2025
Last Updated
January 23, 2026
34
ACTUAL participants
ledaborbactam etzadroxil
DRUG
ceftibuten
DRUG
Lead Sponsor
Basilea Pharmaceutica
Collaborators
NCT07310264
NCT07052162
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06342713