Clinical trial NCT03542916: Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-31
Enrollment: 56
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assess Cmax of darbepoetin alfa in SC treatment group
timeFrame: SC treatment:Pre-dose and after dose up to 16 days
measure: Assess Cmax of darbepoetin alfa in IV treatment group
timeFrame: IV treatment:Pre-dose and after dose 12 days
measure: Assess AUClast of darbepoetin alfa in SC treatment group
timeFrame: SC treatment:Pre-dose and after dose up to 16 days
measure: Assess AUClast of darbepoetin alfa in IV treatment group
timeFrame: IV treatment:Pre-dose and after dose 12 days
Secondary outcomes:
measure: Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
timeFrame: SC treatment:Pre-dose and after dose up to 16 days
measure: Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
timeFrame: SC treatment:Pre-dose and after dose up to 16 days
measure: Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
timeFrame: SC treatment:Pre-dose and after dose up to 16 days
measure: Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
timeFrame: IV treatment:Pre-dose and after dose 12 days
measure: Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
timeFrame: IV treatment:Pre-dose and after dose 12 days
measure: Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
timeFrame: IV treatment:Pre-dose and after dose 12 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: 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.