Healthy Subjects
Conditions
Brief summary
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
Interventions
IV infusion
Sponsors
Venatorx Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults 18-55 years 2. Males or non-pregnant, non-lactating females 3. Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \>50.0 kg. 4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study
Exclusion criteria
1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders 2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug 3. Recent history of known or suspected Clostridioides difficile infection 4. Abnormal ECG or history of clinically significant abnormal rhythm disorder 5. Abnormal lab tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ELF Cmax | 0-8 hours after 6th dose | Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF) |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | Day 1 - Day 8 |
Countries
United States
Outcome results
None listed