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A Study of HM10560A in Healthy Male Subject

NCT01093742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-02-07

No results posted yet for this study

Summary

* Study Design

* Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
* Four ascending dose cohorts.
* In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
* Objectives

* The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

HM10560A

Subcutaneously administrate at 0 hour on Day 1

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Jahon Kang · Hanmi pharma.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT01093742 on ClinicalTrials.gov