Clinical Trial of Efepoetin Alfa in Healthy Subjects

NCT ID: NCT06490939

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2025-03-25

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asian

Single-dose

Group Type: EXPERIMENTAL

Efepoetin Alfa

Intervention Type: DRUG

Single-intravenous administration

Caucasian

Single-dose

Group Type: EXPERIMENTAL

Efepoetin Alfa

Intervention Type: DRUG

Single-intravenous administration

Interventions

Efepoetin Alfa

Single-intravenous administration

Intervention Type: DRUG

Other Intervention Names

GX-E4

Eligibility Criteria

Inclusion Criteria

1. Adult males and females between the ages of 19-45

2. Asian or Caucasian

3. Body weight >50 kg and <90 kg, BMI 18 ~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)

4. Normal hemoglobin range.

5. Normal Serum ferritin and transferrin saturation range.

6. Normal serum folate range

7. Normal vitamin B12 range

8. White blood cell >=3.0 X 10^3 /mm3

9. Platelet >= 150 X 10^3/mm^3 and <450 X 10^3/mm^3

10. Nonsmoker or smoker who smokes below 10 cigarettes a day.

Exclusion Criteria

1. An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.

2. Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.

3. Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.

4. Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.

5. Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)

6. 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

7. C-reactive protein level >4mg/dL at 2 weeks prior to the IMP administration.

8. A drug abuse history, or positive in a urine drug-screening test(cocaine, amphetamines, barbiturates, opiates, benzodiazepine, and cannabinoids)

9. Signs of fever, with a temperature of over 38°C, within 1 week before particiation

10. History of epileptic seizure within 6 months before participation

11. Positive to HIV antibody, HBsAg, and HCV antibody test.

12. Consumes over 21 units of alcohol per week, or a person who cannot stay sober for the duration of the entire trial period.

13. Blood donation or a bleeding episode of more than 400mL within 8 weeks prior to study participation

14. The maximum length of the spleen >16cm.

15. Person thought inappropriate by the investigator in consideration of the laboratory test results.

16. Pregnant or breast-feeding.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hanyang University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-E4-HV-003

Identifier Type: -

Identifier Source: org_study_id