Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.

Detailed Description
-----------------
The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP in healthy male volunteers.

Official Title
-----------------
A Single-blind, Randomized, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-40001 and NESP® in Healthy Male Volunteers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: CJ-40001 60ug
* Drug: NESP 60ug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 19 to 55 years at the screening Subject with BMI between 19 kg/m2 and 28 kg/m2 (inclusive) Subject who is able to participate in the whole study process Subject who provided written informed consent voluntarily after being fully informed of the study objectives, procedures and the investigational product Exclusion Criteria: Subject who has a medical history of gastrointestinal, cardiovascular, respiratory, hepatobiliary, hematologic/oncologic, neuropsychologic, endocrinological, immunologic or renal disease that may be aggravated by the investigational product Subject with a systolic blood pressure of equal to or greater than 140 or less than 90 mmHg or with a diastolic blood pressure of equal to or greater than 90 or less than 60 mmHg Subject who has allergic disease that needs to be treated Subject with a history of drug allergies to any ingredient of the investigational product or marketed drug Subject with a blood hemoglobin value less than 13 g/dL or more than 17 g/dL Subject with a blood reticulocyte value more than the upper reference limit Subject with a blood vitamin B12 or ferritin or transferrin value less than the lower reference limit Subject with any non-negative results in blood serology (HBV, HCV, HIV, RPR) tests and in an examination of syphilis Subject who smokes more than 10 cigarettes per day Subject who consumes alcohol more than 140 g per week Subject with a history of drug abuse Subject who was administered with any investigational product, erythropoietin or iron supplement within 60 days prior to the screening Subject who donated whole blood within 60 days or blood components within 30 days prior to the screening Subject who took any herbal medicine within 30 days or any prescription drug within 14 days or over-the-counter drug considered to affect study within 10 days prior to the screening Subject who does not agree to use medically acceptable methods of contraception or who has plan to provide sperm during the study period Subject whom the investigator determined to have clinically significant findings in ECG Subject whose liver function is decreased with an AST, ALT or bilirubin value more than 1.5 times the upper reference limit Subject whose renal function is decreased with a GFR value calculated using MDRD equation less than the lower reference limit Subject whom the investigator determined to have clinically significant findings in clinical laboratory test Subject who is inappropriate as a subject of this study by the investigator's decision

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-40001<br>CJ-40001 60ug SC, IV injection | Drug: CJ-40001 60ug<br>* CJ-40001 60ug SC, IV injection<br>|
| Active Comparator: NESP<br>NESP 60ug SC, IV injection | Drug: NESP 60ug<br>* NESP 60ug SC, IV injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Cmax of darbepoetin alfa in SC treatment group |  | SC treatment:Pre-dose and after dose up to 16 days | 
| Assess Cmax of darbepoetin alfa in IV treatment group |  | IV treatment:Pre-dose and after dose 12 days | 
| Assess AUClast of darbepoetin alfa in SC treatment group |  | SC treatment:Pre-dose and after dose up to 16 days | 
| Assess AUClast of darbepoetin alfa in IV treatment group |  | IV treatment:Pre-dose and after dose 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group |  | SC treatment:Pre-dose and after dose up to 16 days | 
| Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group |  | SC treatment:Pre-dose and after dose up to 16 days | 
| Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group |  | SC treatment:Pre-dose and after dose up to 16 days | 
| Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group |  | IV treatment:Pre-dose and after dose 12 days | 
| Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group |  | IV treatment:Pre-dose and after dose 12 days | 
| Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group |  | IV treatment:Pre-dose and after dose 12 days |