This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages.
This Phase I trial will be conducted as an open label trial in 15 healthy adults. All subjects will receive a specific intravenous dose of Aerucin. There are three study groups, each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin . Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of Aerucin . The dose levels of Aerucin are selected for this study based on animal studies showing protection in an animal model and absence of adverse effects in toxicological studies. Groups will be enrolled sequentially.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
IV Aerucin 2.0 mg/kg over 1 hour
IV Aerucin 8.0 mg/kg over 1 hour
IV Aerucin 20 mg/kg over 1 hour
SNBL-CPC
Baltimore, Maryland, United States
Adverse Events
Number and % of subjects experiencing adverse events following dosing
Time frame: 28 and 84 days following dosing
Serious Adverse Events
Number and % of subjects experiencing Serious Adverse Events following dosing
Time frame: 24 and 84 days following dosing
Solicited Adverse Events
Number and % of subjects experiencing Solicited Adverse Events following dosing
Time frame: 7 days following dosing
CMax -Observed maximum plasma concentration
Pharmacokinetics Characteristics
Time frame: 84 days following dosing
TMax-Time to reach maximum plasma concentration
Pharmacokinetics Characteristics
Time frame: 84 days following dosing
AUC0-last Area under the the concentration time curve
Pharmacokinetics Characteristics
Time frame: 84 days following dosing
AUC0-∞ Area under the concentration time curve from zero to infinite time
Pharmacokinetics Characteristics
Time frame: 84 days following dosing
Terminal phase elimination rate
Pharmacokinetics Characteristics
Time frame: 84 days following dosing
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Terminal elimination half-life
Pharmacokinetics Characteristics
Time frame: 84 days following dosing