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