NCT01093729

A Study of HM11260C in Healthy Male Subject

A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.

Detailed description

Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM11260C	HM11260C 0.5mcg/kg or Placebo
DRUG	HM11260C	HM11260C 2mcg/kg or Placebo
DRUG	HM11260C	HM11260C 4mcg/kg or Placebo
DRUG	HM11260C	HM11260C 8mcg/kg or Placebo
DRUG	HM11260C	HM11260C 14mcg/kg or Placebo

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-03-26
• Last updated: 2014-02-07