Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
| End Date: | June 2011 |
A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.
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.
Secondary objectives:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- to compare the PK of HM10460A in Japanese and Caucasian subjects.
- to assess the relationship between the serum concentration of HM10460A and absolute
neutrophil count (ANC).
- to assess the relationship between the serum concentration of HM10460A and CD34+ cell
counts in the blood.
- To assess the immunogenicity potential of HM10460A by measuring binding antibodies
(bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a
single subcutaneous dose of HM10460A.
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