Healthy
Conditions
Brief summary
* To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 (SAD & MAD) in healthy male subjects. * To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in healthy male subjects
Interventions
DRUGAAI101 i.v.
600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
DRUGSaline 0.9% infusion
Vehicle infusion
DRUGPiperacillin i.v.
piperacillin 3 g i.v.
DRUGCefepime i.v.
cefepime 1 g i.v.
Sponsors
Allecra
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male healthy volunteers aged between 18 and 45 years (inclusive) at screening. * Body mass index (BMI) of 18.0 to 30.0 Kg/m2 (inclusive) at screening. * Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings (all results were to be within normal range or considered non-clinically significant by the investigator). * Non-smoker or smoker of fewer than 10 cigarettes per day as determined by medical history. Had to be able to abstain from smoking during the inpatient stay. * Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study. Main
Exclusion criteria
* Any significant cardiovascular (e.g., hypertension), hepatic, renal, respiratory (e.g., childhood asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia), immunologic, hematological, neurologic, or psychiatric disease. * Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before study Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile - Number of Subjects With at Least one Adverse Event | Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment | Safety will be evaluated from reported signs and symptoms and clinical laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AAI101 maximum plasma concentration (Cmax) | Up to 24 hours post-dose | Cmax will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin |
| AAI101 Clast | Up to 24 hours post-dose | Clast will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin |
| AAI101 AUC(0-t) - AUC(0-8) | Up to 24 hours post-dose | AAI101 Urea Under the Curve will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin |
| AAI101 half life (t1/2) | Up to 24 hours post-dose | AAI101 t1/2 plasma pharmacokinetic parameter will be compared for AAI101 alone or in the presence of cefepime or piperacillin |
Outcome results
None listed