Overview

Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Study Design - Randomized, double-blind, placebo-controlled, escalating single-dose design. - Six ascending dose cohorts - In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control). - Primary Objective - to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.
Phase:
Phase 1
Details
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Treatments:
Immunoglobulin Fc Fragments