HealthyPhase 1NCT06490939
Clinical Trial of Efepoetin Alfa in Healthy Subjects
A Phase 1 study testing Efepoetin Alfa in people with Healthy, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Efepoetin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Oct 2024to 25 Mar 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and females between the ages of 19-45
- Asian or Caucasian
- Body weight >50 kg and <90 kg, BMI 18 ~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)
- Normal hemoglobin range.
- Normal Serum ferritin and transferrin saturation range.
- Normal serum folate range
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- Normal vitamin B12 range
- White blood cell >=3.0 X 10^3 /mm3
- Platelet >= 150 X 10^3/mm^3 and <450 X 10^3/mm^3
- Nonsmoker or smoker who smokes below 10 cigarettes a day.
Who cannot join
- An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.
- Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.
- Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.
- Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.
- Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)
- Systolic blood pressure below 90mmHg or above 140mmHg, or diastolic blood pressure below 50mmHg or above 90mmHg after taking a rest over 3 minutes; pulse rate over 100bpm
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- C-reactive protein level >4mg/dL at 2 weeks prior to the IMP administration.
- A drug abuse history, or positive in a urine drug-screening test(cocaine, amphetamines, barbiturates, opiates, benzodiazepine, and cannabinoids)
- Signs of fever, with a temperature of over 38°C, within 1 week before particiation
- History of epileptic seizure within 6 months before participation
- Positive to HIV antibody, HBsAg, and HCV antibody test.
- Consumes over 21 units of alcohol per week, or a person who cannot stay sober for the duration of the entire trial period.
- Blood donation or a bleeding episode of more than 400mL within 8 weeks prior to study participation
- The maximum length of the spleen >16cm.
- Person thought inappropriate by the investigator in consideration of the laboratory test results.
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel-group, Single-center, Phase I Study to Compare the Pharmacokinetic/Pharmacodynamic Characteristics, Safety, and Tolerability of a Single Intravenous Administration of Efepoetin Alfa in Healthy Caucasian and Asian Volunteers
An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects
Read the detailed description
This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa, GX-E4, in healthy Caucasian and Asian volunteers.
- Conditions
- Healthy
- Being tested
- Efepoetin Alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efepoetin AlfaDrug
Also called GX-E4
Single-intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Asian | Experimental | Single-dose Receives: Drug: Efepoetin Alfa |
| Caucasian | Experimental | Single-dose Receives: Drug: Efepoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
PharmacoKinetic parameters (Cmax)
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters peak blood concentration
Measured: up to 4 weeks
PharmacoKinetic parameters (AUClast)
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters area under the blood concentration-time curve
Measured: up to 4 weeks
Secondary outcomes (2)
PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)
Pharmacokinetic parameters of Efepoetin alfa blood concentration after a single intravenous administration of the investigational product
Measured: up to 4 weeks
Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)
Pharmacodynamic parameters of hemoglobin, reticulocyte and reticulocyte hemoglobin content after administration of the investigational product
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start29 Oct 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490939
- Sponsor's protocol ID
- GX-E4-HV-003
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group, Single-center, Phase I Study to Compare the Pharmacokinetic/Pharmacodynamic Characteristics, Safety, and Tolerability of a Single Intravenous Administration of Efepoetin Alfa in Healthy Caucasian and Asian Volunteers
- ClinicalTrials.gov ID
- NCT06490939
- Acronym / sponsor ID
- GX-E4-HV-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 8 Jul 2024 (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.
An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects
Detailed description
This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa, GX-E4, in healthy Caucasian and Asian volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asian | Experimental | Drug: Efepoetin AlfaSingle-dose |
| Caucasian | Experimental | Drug: Efepoetin AlfaSingle-dose |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult males and females between the ages of 19-45
- Asian or Caucasian
- Body weight >50 kg and <90 kg, BMI 18 ~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)
- Normal hemoglobin range.
- Normal Serum ferritin and transferrin saturation range.
Key exclusion criteria (16 listed)
- An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.
- Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.
- Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.
- Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.
- Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)
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 |
|---|---|---|
| Efepoetin AlfaAlso: GX-E4Single-intravenous administration | Drug | Asian, Caucasian |
Primary outcome
PharmacoKinetic parameters (Cmax)
Time frame: up to 4 weeks
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters peak blood concentration
PharmacoKinetic parameters (AUClast)
Time frame: up to 4 weeks
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters area under the blood concentration-time curve
2 secondary outcomes
PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)
Time frame: up to 4 weeks
Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)
Time frame: up to 4 weeks
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 21 Aug 2025.
- Individual participant dataSharing planned: No
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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 Efepoetin Alfa in people with Healthy, run by Genexine, Inc. 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 10 inclusion and 16 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 21 Aug 2025. 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?
PharmacoKinetic parameters (Cmax) (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.