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

Study Overview
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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.

Official Title
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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

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: Somatropin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, Safety, Male