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

NCT01037543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Hanmi Clinical · California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-02-28
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037543 on ClinicalTrials.gov