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

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

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 Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: CJ-40001 60ug; Drug: NESP 60ug

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CJ-40001; CJ-40001 60ug SC, IV injection	Drug: CJ-40001 60ug; CJ-40001 60ug SC, IV injection
ACTIVE_COMPARATOR: NESP; NESP 60ug SC, IV injection	Drug: NESP 60ug; NESP 60ug SC, IV injection

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CJ_EPO_101