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

Phase 1

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Somatropin; Drug: Placebo

• Registration Number: NCT01440686
• Lead Sponsor: HanAll BioPharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Healthy male subjects
• Age(yr)between 19 and 50
• Signed written informed consent

Exclusion Criteria

• Known hypersensitivity to Octreotide or hGH(human growth hormone)
• History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer
• Alcoholic, smokers or drug abusers
• Other conditions which in the opinion of the investigator preclude enrollment into the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL-032 30mg	Placebo	A single dose 30mg administered orally
HL-032 60mg	Placebo	A single dose 60mg administered orally
HL-032 120mg	Placebo	A single dose 120mg administered orally
HL-032 120mg	Somatropin	A single dose 120mg administered orally
HL-032 30mg	Somatropin	A single dose 30mg administered orally
HL-032 60mg	Somatropin	A single dose 60mg administered orally

Primary Outcome Measures

Name	Time	Method
Area under the serum hGH(human growth hormone)concentration-time curve	From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
Maximum observed serum hGH concentration	Over a 32-hour sampling period

Secondary Outcome Measures

Name	Time	Method
Area under the effect(IGF-1, IGFBP-3, NEFA)curve	From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
Maximum IGF-1, IGFBP-3, NEFA effect	Over a 32-hour sampling period

Trial Locations

Locations (1)

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute; 🇰🇷 Seoul, Korea, Republic of