Evaluating Efepoetin Alfa in Healthy 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 Caucasian and Asian Volunteers
PHASE1 · Genexine, Inc. · NCT06490939
This study is testing how a single dose of Efepoetin Alfa affects healthy adults aged 19 to 45 to see how the drug works in the body and if it is safe.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 45 Years |
| Sex | All |
| Sponsor | Genexine, Inc. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06490939 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial is designed to assess the pharmacokinetic and pharmacodynamic properties, safety, and tolerability of a single intravenous dose of Efepoetin Alfa in healthy adult volunteers. The study will involve a parallel-group design and will focus on healthy Caucasian and Asian participants aged 19 to 45. By administering Efepoetin Alfa, researchers aim to gather objective data on how the drug behaves in the body and its effects on various biological markers.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult males and females aged 19-45, of Asian or Caucasian descent, with specific health criteria.
Not a fit: Patients with a history of allergies, significant health conditions, or prior exposure to erythropoietin treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of Efepoetin Alfa, potentially leading to improved treatments for conditions requiring erythropoiesis stimulation.
How similar studies have performed: While this study focuses on a specific population and drug, similar studies have previously shown success in evaluating the pharmacokinetics and safety of erythropoietin treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Hanyang University Medical Center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: HeeWon Kim
- Email: clinicalgx@genexine.com
- Phone: +82-2-6098-2751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy