This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
62
single intravenous doses
Unnamed facility
Anaheim, California, United States
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: up to 197 days
Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
Time frame: up to 197 days
Pharmacodynamics: Plasma (free and total) soluble P-selectin
Time frame: up to 197 days
Safety: Incidence of adverse events
Time frame: approximately 10 months
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