A Study of HM10560A in Healthy Male Subject

Study Overview
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Brief Summary
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Study Design Randomized, Double-blind, Placebo-controlled, escalating single-dose design. Four ascending dose cohorts. In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control). Objectives The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

Detailed Description
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The secondary objectives of the study are as follows: To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.

Official Title
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A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HM10560A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study Body mass index of ≥19 and ≤26 Subject Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test Able to participate in all procedure SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min AST, ALT <1.5 X UNL, CPK < 2 X UNL Able to abstain from alcohol and smoke during study period Consented to contraception until 2 month after end of the study Exclusion Criteria: Acute infection history within 14 days Prior exposure or hypersensitivity to recombinant human growth hormone Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment Caffeine, alcohol and smoke abuse History of hemophilia or anticoagulant treatment Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines Blood donation or significant blood loss within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1. Receipt of another investigational medication within 60 days prior to Day 1 Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day 1. Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 54 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort 1<br>HM10560A 0.089 mg/kg or Placebo | Drug: HM10560A<br>* Subcutaneously administrate at 0 hour on Day 1<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: cohort 2<br>HM10560A 0.179 mg/kg or Placebo | Drug: HM10560A<br>* Subcutaneously administrate at 0 hour on Day 1<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: cohort 3<br>HM10560A 0.357 mg/kg or Placebo | Drug: HM10560A<br>* Subcutaneously administrate at 0 hour on Day 1<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: cohort 4<br>HM10560A 0.714 mg/kg or Placebo | Drug: HM10560A<br>* Subcutaneously administrate at 0 hour on Day 1<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Investigate Safety of HM10560A: Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability | 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy