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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HM10460A or placebo or Neulasta

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037543

08-HM10460A-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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84 participants in 6 patient groups

Cohort 1

Experimental group

Description:

1.1 mcg/kg of HM10460A, placebo, or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta

Cohort 2

Experimental group

Description:

3.3 mcg/kg HM10460A, placebo or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta

Cohort 3

Experimental group

Description:

10 mcg/kg of HM10460A, placebo, or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta

Cohort 4

Experimental group

Description:

30 mcg/kg of HM10460A, placebo, or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta

Cohort 5

Experimental group

Description:

90 mcg/kg or HM10460A, placebo, or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta

Cohort 6

Experimental group

Description:

270 mcg/kg of HM10460A, placebo, or Neulasta

Treatment:

Drug: HM10460A or placebo or Neulasta