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

Growth Hormone Deficiency Clinical Trial

— HL-032  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440686
• Other study ID #: HGR10I_1
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2011
• Last updated: October 15, 2012
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
• Placebo
Tablets, oral administrations

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Maximum observed serum hGH concentration		Over a 32-hour sampling period	Yes
Secondary	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	No
Secondary	Maximum IGF-1, IGFBP-3, NEFA effect		Over a 32-hour sampling period	No