The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation. Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Richmond Pharmacology Ltd.
London, Saint George's University of London, United Kingdom
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration
Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables.
Time frame: Up to 13 weeks
Assessment of pharmacokinetics of SOBI002 through analysis of serum samples
Time frame: Up to 13 weeks
Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity
Time frame: Up to 13 weeks
Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies
Time frame: Up to 13 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.