Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Hydroxypropyl-beta-cyclodextrin (HPβCD)
Number of subjects with adverse events
Time frame: up to 12 days after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate, respiratory rate, oral body temperature
Time frame: up to 12 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 12 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 12 days after drug administration
Plasma concentration time profiles
Time frame: up to 96 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)
Time frame: up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 96 hours after drug administration
Mean residence time of the analyte in the body (MRT)
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Time frame: up to 96 hours after drug administration
Total clearance of the analyte in plasma (CL)
Time frame: up to 96 hours after drug administration
Apparent volume of distribution at steady state (Vss)
Time frame: up to 96 hours after drug administration
Amount of drug excreted into urine (Ae)
Time frame: up to 72 hours after drug administration