NCT01037543

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM10460A or placebo or Neulasta	Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2009-12-23
• Last updated: 2014-02-07

Locations

1 site across 1 country: United States