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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

October 18, 2009
February 5, 2014
October 2009
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00998283 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
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
  • 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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: HM10460A 5μg/kg
    Subcutaneously administrate at 0 hour on Day 1
  • Drug: HM10460A 15μg/kg
    Subcutaneously administrate at 0 hour on Day 1
  • Drug: HM10460A 45μg/kg
    Subcutaneously administrate at 0 hour on Day 1
  • Drug: HM10460A 135μg/kg
    Subcutaneously administrate at 0 hour on Day 1
  • Drug: HM10460A 350μg/kg
    Subcutaneously administrate at 0 hour on Day 1
  • Drug: Placebo
    Subcutaneously administrate at 0 hour on Day 1
  • Experimental: Cohort 1
    Administration of HM10460A 5μg/kg or Placebo
    Interventions:
    • Drug: HM10460A 5μg/kg
    • Drug: Placebo
  • Experimental: Cohort 2
    Administration of HM10460A 15μg/kg or placebo
    Interventions:
    • Drug: HM10460A 15μg/kg
    • Drug: Placebo
  • Experimental: Cohort 3
    Administration of HM10460A 45μg/kg or placebo
    Interventions:
    • Drug: HM10460A 45μg/kg
    • Drug: Placebo
  • Experimental: Cohort 4
    Administration of HM10460A 135μg/kg or placebo
    Interventions:
    • Drug: HM10460A 135μg/kg
    • Drug: Placebo
  • Experimental: Cohort 5
    Administration of HM10460A 350μg/kg or placebo
    Interventions:
    • Drug: HM10460A 350μg/kg
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00998283
09-HM10460A-102
Yes
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Hanmi Clinical Seoul
Hanmi Pharmaceutical Company Limited
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP