NCT01093742

A Study of HM10560A in Healthy Male Subject

A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 54 Years
• Healthy volunteers: Accepted

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.

Detailed description

The secondary objectives of the study are as follows: * To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM10560A	Subcutaneously administrate at 0 hour on Day 1
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-03-26
• Last updated: 2014-02-07

Locations

1 site across 1 country: South Korea