Clinical Trial of Efepoetin Alfa in Healthy Subjects

NCT06490939 | Completed Phase 1

• 1 other identifier: GX-E4-HV-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to 4 weeks

Secondary Outcomes (2)

• PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)

  up to 4 weeks

• Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)

  up to 4 weeks

Other Outcomes (3)

• Exploratory

  up to 4 weeks

• Incidence, nature and severity of adverse events

  up to 4 weeks

• Immunogenicity

  up to 4 weeks

Study Arms (2)

Asian

EXPERIMENTAL

Single-dose

Drug: Efepoetin Alfa

Caucasian

EXPERIMENTAL

Single-dose

Drug: Efepoetin Alfa

Interventions

Efepoetin Alfa DRUG

Single-intravenous administration

Also known as: GX-E4

Asian; Caucasian

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 8, 2024
• Study Start: October 29, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)