A Phase 1 interventional study of Efepoetin Alfa in Healthy, sponsored by Genexine, Inc.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Genexine, Inc. · Phase 1, Interventional, and Treatment
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
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.
Genexine, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-dose
Drug: Efepoetin Alfa
Single-dose
Drug: Efepoetin Alfa
Single-intravenous administration
Also known as: GX-E4
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
Time frame: 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
Time frame: up to 4 weeks
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
Time frame: 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
Time frame: up to 4 weeks
Exploratory
Assessment or iron storage function
Time frame: up to 4 weeks
Incidence, nature and severity of adverse events
Graded according to NCI CTCAE v5.0
Time frame: up to 4 weeks
Immunogenicity
Incidence of anti-drug antibodies (ADAs) relative to baseline
Time frame: up to 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Mar 2025, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efepoetin alfa