A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor
injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese
descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be
enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of
plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC
dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled
first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the
highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose
escalation are met.