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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01440686
First received: September 23, 2011
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency
 Drug: Somatropin
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Maximum observed serum hGH concentration [ Time Frame: Over a 32-hour sampling period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum IGF-1, IGFBP-3, NEFA effect [ Time Frame: Over a 32-hour sampling period ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HL-032 30mg
A single dose 30mg administered orally
 Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Other Name: Somatropin
Drug: Placebo
Tablets, oral administrations
Other Name: Placebo
Experimental: HL-032 60mg
A single dose 60mg administered orally
 Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Other Name: Somatropin
Drug: Placebo
Tablets, oral administrations
Other Name: Placebo
Experimental: HL-032 120mg
A single dose 120mg administered orally
 Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Other Name: Somatropin
Drug: Placebo
Tablets, oral administrations
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440686

Locations
Korea, Republic of
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, Medicine Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
  More Information

No publications provided

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01440686     History of Changes
Other Study ID Numbers: HGR10I_1
Study First Received: September 23, 2011
Last Updated: October 15, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by HanAll BioPharma Co., Ltd.:
Pharmacokinetics
Pharmacodynamics
Safety
Male

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
 Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013