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.

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.

Inclusion Criteria:

• BMI of 18 - 29.9 kg/m2
• have not used tobacco or nicotine containing products for at least 3 months prior to dosing
• be able to remain abstinent throughout the study.

Exclusion Criteria:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• positive urine drug/alcohol testing
• Positive for HIV, HBsAg, HCV ab
• History of anaphylactic reaction to medicine or environmental exposure