Healthy Subjects
Conditions
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.
Interventions
DRUGCJ-40001 60ug
CJ-40001 60ug SC, IV injection
DRUGNESP 60ug
NESP 60ug SC, IV injection
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group | IV treatment:Pre-dose and after dose 12 days |
| Assess Temax 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 IV treatment group | IV treatment:Pre-dose and after dose 12 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 |
Countries
South Korea
Outcome results
None listed