Healthy Subjects
Conditions
Keywords
bronchial epithelial lining fluid
Brief summary
The primary objective of this study is to measure and compare the concentration of AAI101 and cefepime in bronchial epithelial lining fluid (ELF) and plasma following administration of cefepime/AAI101 combination in healthy subjects.
Interventions
DRUGCefepime 2 gram
Combination of cefepime 2 gram with AAI101 1 gram
Sponsors
Allecra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated, written informed consent prior to any study-specific procedures. 2. Healthy male and female subjects aged 18 to 65 years with veins suitable for cannulation or repeated venipuncture. Female patients can participate if at least 1 of the following criteria are met: * Are of non-childbearing potential defined as * Permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy or confirmed tubal occlusion (not tubal ligation); * Postmenopausal, as defined as at least 1 year post-cessation of menses (without an alternative medical cause), and per documentation provided by a medical professional; * Postmenopausal status will be confirmed with a screening serum follicle stimulating hormone (FSH) level greater than 40 milli-international units per milliliter (mlU/mL). * Patient has a negative urine and/or serum pregnancy test (serum β-human chorionic gonadotropin) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after the last dose of i.v. study therapy; 3. Have a body mass index (BMI) between 18 and 32 kg/m2. 4. As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements. 4.2
Exclusion criteria
Subjects should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration of cefepime and AAI101 in the lung | Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose | Maximum concentration of cefepime and AAI101 in Bronchoalveolar lavage (BAL) samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration of cefepime and AAI101 in plasma | Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose | Maximum concentration of cefepime and AAI101 in plasma samples |
Countries
United Kingdom
Outcome results
None listed