Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
NCT ID: NCT01037543
Last Updated: 2014-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2009-11-30
2011-04-30
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Cohort 1
1.1 mcg/kg of HM10460A, placebo, or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Cohort 2
3.3 mcg/kg HM10460A, placebo or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Cohort 3
10 mcg/kg of HM10460A, placebo, or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Cohort 4
30 mcg/kg of HM10460A, placebo, or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Cohort 5
90 mcg/kg or HM10460A, placebo, or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Cohort 6
270 mcg/kg of HM10460A, placebo, or Neulasta
HM10460A or placebo or Neulasta
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* positive urine drug/alcohol testing
* Positive for HIV, HBsAg, HCV ab
* History of anaphylactic reaction to medicine or environmental exposure
20 Years
45 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmi Clinical
Role: PRINCIPAL_INVESTIGATOR
California
Locations
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California City, California, United States
Countries
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References
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Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.
Other Identifiers
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08-HM10460A-101
Identifier Type: -
Identifier Source: org_study_id
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