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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01037543
First received: December 21, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention Phase
Healthy
Drug: HM10460A or placebo or Neulasta
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs). [ Time Frame: Time points where appropriate. ] [ Designated as safety issue: Yes ]
  • Samples for immunogenicity [ Time Frame: Days -1, 15, 22, and 42. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters measured from Serum and Urine samples. [ Time Frame: Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose. ] [ Designated as safety issue: No ]
  • Calculation of ANC and CD34+ cell counts. [ Time Frame: pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22. ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
1.1 mcg/kg of HM10460A, placebo, or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF
Experimental: Cohort 2
3.3 mcg/kg HM10460A, placebo or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF
Experimental: Cohort 3
10 mcg/kg of HM10460A, placebo, or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF
Experimental: Cohort 4
30 mcg/kg of HM10460A, placebo, or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF
Experimental: Cohort 5
90 mcg/kg or HM10460A, placebo, or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF
Experimental: Cohort 6
270 mcg/kg of HM10460A, placebo, or Neulasta
Drug: HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other Name: LAPS-G-CSF

Detailed 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.
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037543

Locations
United States, California
California, California, United States
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hanmi Clinical California
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01037543     History of Changes
Other Study ID Numbers: 08-HM10460A-101
Study First Received: December 21, 2009
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014