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

HK inno.N

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: NESP 60ug

Drug: CJ-40001 60ug

Study type

Interventional

Funder types

Industry

Identifiers

NCT03542916

CJ_EPO_101

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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