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

NCT00998283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-02-07

No results posted yet for this study

Summary

* 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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Hanmi Clinical · Seoul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT00998283 on ClinicalTrials.gov