NCT00998283

Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects

A Randomized, Double-Blind, Placebo-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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. * Five ascending dose cohorts. * In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control) * Objectives * The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects

Detailed description

The secondary objectives of the study are as follows: * to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A. * 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 (HM10460A, native G-CSF antibody,neutralizing antibodies) of a single subcutaneous dose of HM10460A.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM10460A 5μg/kg	Subcutaneously administrate at 0 hour on Day 1
DRUG	HM10460A 15μg/kg	Subcutaneously administrate at 0 hour on Day 1
DRUG	HM10460A 45μg/kg	Subcutaneously administrate at 0 hour on Day 1
DRUG	HM10460A 135μg/kg	Subcutaneously administrate at 0 hour on Day 1
DRUG	HM10460A 350μg/kg	Subcutaneously administrate at 0 hour on Day 1
DRUG	Placebo	Subcutaneously administrate at 0 hour on Day 1

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-10-20
• Last updated: 2014-02-07

Locations

1 site across 1 country: South Korea