Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00998283
First received: October 18, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose
  • Study Design

    • Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
    • Five ascending dose cohorts.
    • In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control)
  • Objectives

    • The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects

Condition Intervention Phase
Healthy
Drug: HM10460A 5μg/kg
Drug: HM10460A 15μg/kg
Drug: HM10460A 45μg/kg
Drug: HM10460A 135μg/kg
Drug: HM10460A 350μg/kg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects

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, and adverse effects (AEs) [ Time Frame: Time point of collection, where appropriate ] [ Designated as safety issue: Yes ]
  • Samples for immunogenicity [ Time Frame: Time point of collection, where appropriate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum PK parameters/Urine PK parameters [ Time Frame: Serum : pre-dose, 0.25, 05, 0.75, 1,2,3,4,6,8,12,16,24,36,48,72,96,120,144 (hr)// Urine : 0-6, 6-12, 12-24, 24-36, 36,48(hr) ] [ Designated as safety issue: No ]
  • Calculation of the ANC (Absolute Neutrophil count) & CD34+ cell. [ Time Frame: Pre-dose, 24 and 48 hours post-dose, on return Days 4,5,6,7,11,15 and 22 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Administration of HM10460A 5μg/kg or Placebo
Drug: HM10460A 5μg/kg
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Subcutaneously administrate at 0 hour on Day 1
Experimental: Cohort 2
Administration of HM10460A 15μg/kg or placebo
Drug: HM10460A 15μg/kg
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Subcutaneously administrate at 0 hour on Day 1
Experimental: Cohort 3
Administration of HM10460A 45μg/kg or placebo
Drug: HM10460A 45μg/kg
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Subcutaneously administrate at 0 hour on Day 1
Experimental: Cohort 4
Administration of HM10460A 135μg/kg or placebo
Drug: HM10460A 135μg/kg
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Subcutaneously administrate at 0 hour on Day 1
Experimental: Cohort 5
Administration of HM10460A 350μg/kg or placebo
Drug: HM10460A 350μg/kg
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Subcutaneously administrate at 0 hour on Day 1

Detailed Description:

The secondary objectives of the study are as follows:

  • to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
  • 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 (HM10460A, native G-CSF antibody,neutralizing antibodies) of 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:

  • Healthy adult Korean male and/or females, 20 - 45 years of age(inclusive).
  • BMI of 18 - 27kg/m2.
  • Medically healthy with no clinically significant screening results.
  • The following results in laboratory test

    • Absolute neutrophil count (ANC) : 2000 ~ 7500/mm3
  • Non-smokers or subjects who smoke less than 10 cigarettes/day
  • After a confirmed menstrual period, females of childbearing potential must be either sexually inactive (abstinent) for 14 days prior to screening and agree to remain so throughout the study, or have been using a highly effective method of birth control, such as the following examples:

    • intra-uterine device in place for at least 3 months prior to Day 1;
    • stable hormonal contraceptive for at least 3 months prior to Day 1 through completion of study;
    • surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1.
  • Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:

    • bilateral tubal ligation;
    • hysterectomy;
    • hysterectomy with unilateral or bilateral oophorectomy;
    • bilateral oophorectomy.

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 at screening or check-in.
  • Positive testing for HIV, HBsAg, or HCV antibodies.
  • Active infection
  • Positive testing for palpable spleen at screening or check-in.
  • The following results in laboratory test:

    • WBC > 10.0 x 10^3/mm3
    • Hb < 13g/dL
    • Platelet < 150 x 10^3/mm3
    • AST/ALT > 50 IU/L
  • History or presence of alcoholism or drug abuse within 2 years prior to Day 1.
  • History of G-CSF-related product use (i.e., pegfilgrastim, filgrastim).
  • History of anaphylactic reaction to medicine or environmental exposures.
  • Use of any prescription medication (with the exception of hormonal contraceptives for females) or receipt of any blood products within 14 days prior to Day 1.
  • Use of any over-the-counter medication, including herbal products, within 7 days prior to the Day 1. Up to 2 grams per day of acetaminophen is allowed at the discretion of the Investigator.
  • Blood donation or significant blood loss within 56 days prior to Day 1.
  • Plasma donation within 7 days prior to Day 1.
  • Participation in another clinical trial (receipt of last investigational medication) within 30 days prior to Day 1.
  • Females who are pregnant or lactating.
  • Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00998283

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hanmi Clinical Seoul
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT00998283     History of Changes
Other Study ID Numbers: 09-HM10460A-102
Study First Received: October 18, 2009
Last Updated: February 5, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Immunoglobulin Fc Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014