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

October 15, 2012 updated by: HanAll BioPharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HL-032 30mg
A single dose 30mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations
EXPERIMENTAL: HL-032 60mg
A single dose 60mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations
EXPERIMENTAL: HL-032 120mg
A single dose 120mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Kyung-Sang Yu, Medicine, Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (ESTIMATE)

September 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HGR10I_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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