NCT01440686

Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Somatropin	A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
DRUG	Placebo	Tablets, oral administrations

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2011-09-26
• Last updated: 2012-10-16

Locations

1 site across 1 country: South Korea