Status:
COMPLETED
Clinical Trial of Efepoetin Alfa in Healthy Subjects
Lead Sponsor:
Genexine, Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
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...
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 volun...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
- Pregnant or breast-feeding.
Key Trial Info
Start Date :
October 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06490939
Start Date
October 29 2024
End Date
March 25 2025
Last Update
August 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hanyang University Medical Center
Seoul, South Korea, 04763