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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: CJ-40001 60ug; Drug: NESP 60ug

• Registration Number: NCT03542916
• Lead Sponsor: HK inno.N Corporation

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2014-11
• Status Verified: 2015-01
• Study First Submitted: 2015-01-26
• Study Completion: 2015-12
• Study First Submitted QC: 2018-05-30
• Last Update Submitted: 2018-05-30
• Study First Posted: 2018-05-31
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CJ-40001	CJ-40001 60ug	CJ-40001 60ug SC, IV injection
NESP	NESP 60ug	NESP 60ug SC, IV injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assess Emax 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 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 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
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group	SC treatment:Pre-dose and after dose up to 16 days

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of