Ceftibuten-ledaborbactam Etzadroxil for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's possible that taking certain medications might exclude you from participating. It's best to discuss your specific medications with the trial organizers.
Is Ceftibuten-ledaborbactam Etzadroxil safe for humans?
What makes the drug ceftibuten-ledaborbactam etzadroxil unique?
Ceftibuten-ledaborbactam etzadroxil is unique because it combines a cephalosporin antibiotic with a novel beta-lactamase inhibitor, ledaborbactam, to effectively treat complicated urinary tract infections caused by multidrug-resistant bacteria. This combination is taken orally, offering a convenient option compared to other treatments that may require intravenous administration.13456
What data supports the effectiveness of the drug ceftibuten-ledaborbactam etzadroxil?
Research shows that ceftibuten-ledaborbactam etzadroxil is effective against many drug-resistant bacteria, including those causing complicated urinary tract infections. It was able to inhibit a high percentage of multidrug-resistant bacteria in lab tests, suggesting it could be a promising treatment option.12478
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
Venatorx Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55 with a BMI between 18 and 32 kg/m2. Participants must have lab values within specific ranges and cannot be pregnant or breastfeeding. The study excludes anyone not meeting these health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive a single oral dose of ceftibuten and ledaborbactam etzadroxil in different sequences
Treatment Part 2
Participants receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ceftibuten-ledaborbactam Etzadroxil
Find a Clinic Near You
Who Is Running the Clinical Trial?
Venatorx Pharmaceuticals, Inc.
Lead Sponsor
Biomedical Advanced Research and Development Authority
Collaborator