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

Hanmi Pharmaceutical logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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