Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB 722 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB 722 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 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 | up to 12 days after drug administration |
| Number of subjects with clinically significant findings in ECG | up to 12 days after drug administration | |
| Number of subjects with clinically significant findings in laboratory tests | up to 12 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration time profiles | up to 96 hours after drug administration | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 96 hours after drug administration | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hydroxypropyl-beta-cyclodextrin (HPβCD) |
|
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) |
| 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) | up to 96 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 96 hours after drug administration |
| Mean residence time of the analyte in the body (MRT) | up to 96 hours after drug administration |
| Total clearance of the analyte in plasma (CL) | up to 96 hours after drug administration |
| Apparent volume of distribution at steady state (Vss) | up to 96 hours after drug administration |
| Amount of drug excreted into urine (Ae) | up to 72 hours after drug administration |