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

NCT ID: NCT03542916

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CJ-40001

CJ-40001 60ug SC, IV injection

Group Type: EXPERIMENTAL

CJ-40001 60ug

Intervention Type: DRUG

CJ-40001 60ug SC, IV injection

NESP

NESP 60ug SC, IV injection

Group Type: ACTIVE_COMPARATOR

NESP 60ug

Intervention Type: DRUG

NESP 60ug SC, IV injection

Interventions

CJ-40001 60ug

CJ-40001 60ug SC, IV injection

Intervention Type: DRUG

NESP 60ug

NESP 60ug SC, IV injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Kim S, Hong T, Ko JW, Huh W, Kim JR. Comparison of the Pharmacokinetic-Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers. BioDrugs. 2019 Feb;33(1):101-112. doi: 10.1007/s40259-018-0323-0.

Reference Type: DERIVED

PMID: 30506495 (View on PubMed)

Other Identifiers

CJ_EPO_101

Identifier Type: -

Identifier Source: org_study_id