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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014