The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week). Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Multiple doses, weight-based IV administration
Single dose IV matched placebo
Research Site
Leiden, Netherlands
Number of Participants experiencing Adverse Events
Time frame: Throughout the study period- an expected 15 weeks
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Time frame: Throughout the study period- an expected 15 weeks
Presence of anti-BG00010 antibodies in serum
Assessment of study-treatment-specific safety of BG00010
Time frame: Throughout the study period- an expected 15 weeks
Change in pain as measured by Likert numerical pain rating scale
Time frame: Every day for 3 consecutive days prior to baseline throughout the study period
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Throughout the study period at each visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.