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The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 of CJ-40002 | Experimental |
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| Dose level 2 of CJ-40002 | Experimental |
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| Dose level 3 of CJ-40002 | Experimental |
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| Dose level 4 of CJ-40002 | Experimental |
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| Dose level 5 of CJ-40002 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-40002 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC, Cmax | 15 days | |
| Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction) | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Tmax, T1/2, CL/F, Vd | 15 days | |
| Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP | 15 days | |
| Formation of anti-drug antibodies |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
History of allergy or sensitivity to any drug
Subject with the following clinically significant laboratory abnormalities:
Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
History of drug abuse
History of caffeine, alcohol, smoking abuse
Participation in any clinical investigation within 60days prior to study medication dosing
Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
Positive test results for HBs Ab, HCV Ab, HIV test
Subjects considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park, MD, PhD | Yonsei University College of Medicine, Seoul, Korea | Principal Investigator |
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| 29 days |