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

NCT03542916 | Completed Phase 1

• 1 other identifier: CJ_EPO_101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

CJ-40001

EXPERIMENTAL

CJ-40001 60ug SC, IV injection

Drug: CJ-40001 60ug

NESP

ACTIVE COMPARATOR

NESP 60ug SC, IV injection

Drug: NESP 60ug

Interventions

CJ-40001 60ug DRUG

CJ-40001 60ug SC, IV injection

CJ-40001

NESP 60ug DRUG

NESP 60ug SC, IV injection

NESP

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30506495 DERIVED

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: May 31, 2018
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 31, 2018

Record last verified: 2015-01

Locations

KR (1)