To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
West Coast Clinical Trials
Cypress, California, United States
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose: results in death; life-threatening event; requires inpatient hospitalization; significant disability; congenital anomaly; medically important event.
Time frame: Up to 20 weeks
Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings
Time frame: Up to 20 weeks
Percentage of Participants With Anti-BIIB059 Antibodies
Time frame: Up to 20 weeks
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Time frame: Up to 28 days
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: Up to 112 days
Maximum Observed Concentration (Cmax)
Time frame: Up to 112 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),
Time frame: Up to 112 days
Time to Reach Maximum Observed Concentration (Tmax)
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Time frame: Up to 112 days
Terminal Half-Life (t1/2)
Time frame: Up to 112 days
Time of Last Measurable Concentration (Tlast)
Time frame: Up to 112 days
Apparent Total Clearance (CL/F)
Time frame: Up to 112 days
Apparent Volume of Distribution (Vz/F)
Time frame: Up to 112 days