Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects

Study Overview
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Brief Summary
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The objectives of this study are: To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.

Official Title
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A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-40002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers in the age between 19 and 45 years old (inclusive) Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial 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: AST or ALT > 1.25 x Upper Limit Normal (ULN) Total bilirubin > 1.5 x Upper Limit Normal (ULN) CPK > 1.5 x Upper Limit Normal (ULN) eGFR < 60 mL/min/1.73 m2 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level 1 of CJ-40002<br>Single dose 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) | Drug: CJ-40002<br> <br> |
| Experimental: Dose level 2 of CJ-40002<br>Single dose 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) | Drug: CJ-40002<br> <br> |
| Experimental: Dose level 3 of CJ-40002<br>Single dose 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) | Drug: CJ-40002<br> <br> |
| Experimental: Dose level 4 of CJ-40002<br>Single dose 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) | Drug: CJ-40002<br> <br> |
| Experimental: Dose level 5 of CJ-40002<br>Single dose 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) | Drug: CJ-40002<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: AUC, Cmax |  | 15 days | 
| Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction) |  | 29 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 29 days |