Clinical Trial of Efepoetin Alfa in Healthy Subjects

Launched by GENEXINE, INC. · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Efepoetin Alfa, which is given through an intravenous (IV) injection. The main goal is to understand how the body processes this medication, how well it works, and whether it is safe for use. Healthy adults aged 19 to 45 who are Asian or Caucasian, weigh between 50 and 90 kg, and have normal blood levels of hemoglobin and other important substances might be eligible to participate.

Participants will receive a single dose of Efepoetin Alfa and will be monitored for any side effects and how their bodies respond to the drug. It’s important to know that people with certain health issues, allergies, or those who have recently used specific medications or had blood donation may not be able to join the trial. Those interested in participating should be prepared for regular check-ups and tests throughout the study to ensure their safety.

Gender

ALL

Eligibility criteria

• Key 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.
• Key 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.