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

NCT ID: NCT01440686

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Growth Hormone Deficiency

Keywords

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Pharmacokinetics Pharmacodynamics Safety Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HL-032 30mg

A single dose 30mg administered orally

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

Placebo

Intervention Type DRUG

Tablets, oral administrations

HL-032 60mg

A single dose 60mg administered orally

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

Placebo

Intervention Type DRUG

Tablets, oral administrations

HL-032 120mg

A single dose 120mg administered orally

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

Placebo

Intervention Type DRUG

Tablets, oral administrations

Interventions

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Somatropin

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

Intervention Type DRUG

Placebo

Tablets, oral administrations

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HanAll BioPharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, Medicine

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Locations

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Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HGR10I_1

Identifier Type: -

Identifier Source: org_study_id