A Study of HM10560A in Healthy Male Subject

The secondary objectives of the study are as follows:

• To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.

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