The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Single dose, weight-based IV administration
Single dose IV matched placebo
Research Site
Adelaide, South Australia, Australia
Number of participants experiencing Adverse Events (AEs)
Time frame: Up to 56 days post dosing
Change in Likert numerical pain rating scale
Time frame: Up to 56 days post dosing
Change in Quantitative Sensory Test (QST)
QST; Vibratory, Cool Thermal,
Time frame: Up to 28 days post dosing
Change in Intra Epidermal Nerve Fiber Density (IENFD)
Time frame: Up to 28 days post dosing
Maximum observed serum concentration (Cmax)
Time frame: Up to 5 days post dosing
Area under the serum concentration curve (AUC)
Time frame: Up to 5 days post dosing
Terminal half-life (t1/2)
Time frame: Up to 5 days post dosing
Total body clearance (CL)
Time frame: Up to 5 days post dosing
Steady state volume of distribution (Vss)
Time frame: Up to 5 days post dosing
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