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

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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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