Actively Recruiting
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Led by Basilea Pharmaceutica · Updated on 2025-12-18
46
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
B
Basilea Pharmaceutica
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.
CONDITIONS
Official Title
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult male or female between 18 and 55 years of age
- Body mass index (BMI) between 18 and 32 kg/m2
- Laboratory values within defined normal ranges
- Males or non-pregnant, non-lactating females
You will not qualify if you...
- History of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics
- Any acute illness or surgery within the past 3 months deemed clinically relevant
- Positive test for alcohol, drug, or tobacco use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON, Clinical Research Phase I Unit
Lenexa, Kansas, United States, 66219
Actively Recruiting
Research Team
K
Karine Litherland, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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