Healthy SubjectsPhase 1NCT03542916
Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers
A Phase 1 study testing CJ-40001 60ug and NESP 60ug in people with Healthy Subjects, run by HK inno.N Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CJ-40001 60ug and NESP 60ug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- CJ-40001 60ug, NESP 60ug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-40001 60ugDrug
CJ-40001 60ug SC, IV injection
NESP 60ugDrug
NESP 60ug SC, IV injection
| Study group | Role | What they receive |
|---|---|---|
| CJ-40001 | Experimental | CJ-40001 60ug SC, IV injection Receives: Drug: CJ-40001 60ug |
| NESP | Active comparator | NESP 60ug SC, IV injection Receives: Drug: NESP 60ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Cmax of darbepoetin alfa in SC treatment group
Measured: SC treatment:Pre-dose and after dose up to 16 days
Assess Cmax of darbepoetin alfa in IV treatment group
Measured: IV treatment:Pre-dose and after dose 12 days
Assess AUClast of darbepoetin alfa in SC treatment group
Measured: SC treatment:Pre-dose and after dose up to 16 days
Assess AUClast of darbepoetin alfa in IV treatment group
Measured: IV treatment:Pre-dose and after dose 12 days
Secondary outcomes (6)
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Measured: SC treatment:Pre-dose and after dose up to 16 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Measured: SC treatment:Pre-dose and after dose up to 16 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Measured: SC treatment:Pre-dose and after dose up to 16 days
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Measured: IV treatment:Pre-dose and after dose 12 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Measured: IV treatment:Pre-dose and after dose 12 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Measured: IV treatment:Pre-dose and after dose 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study startOct 2014
- Primary completionNov 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542916
- Sponsor's protocol ID
- CJ_EPO_101
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30506495
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03542916
- Acronym / sponsor ID
- CJ_EPO_101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-40001 | Experimental | Drug: CJ-40001 60ugCJ-40001 60ug SC, IV injection |
| NESP | Active comparator | Drug: NESP 60ugNESP 60ug SC, IV injection |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJ-40001 60ugCJ-40001 60ug SC, IV injection | Drug | CJ-40001 |
| NESP 60ugNESP 60ug SC, IV injection | Drug | NESP |
Primary outcome
Assess Cmax of darbepoetin alfa in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Cmax of darbepoetin alfa in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess AUClast of darbepoetin alfa in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess AUClast of darbepoetin alfa in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
6 secondary outcomes
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group
Time frame: SC treatment:Pre-dose and after dose up to 16 days
Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group
Time frame: IV treatment:Pre-dose and after dose 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Derived from this study: PubMed 30506495Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ-40001 60ug and NESP 60ug in people with Healthy Subjects, run by HK inno.N Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Cmax of darbepoetin alfa in SC treatment group (time frame: SC treatment:Pre-dose and after dose up to 16 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.