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Completed

NCT Number: NCT01037543

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

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California City, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM10460A or placebo or Neulasta

Drug

Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.

Other names: LAPS-G-CSF

Primary outcomes

  1. 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.

  2. Samples for immunogenicity

    Time frame: Days -1, 15, 22, and 42.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2009
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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