Healthy
Conditions
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.
Interventions
DRUGEfepoetin Alfa
Single-intravenous administration
Sponsors
Genexine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PharmacoKinetic parameters (Cmax) | up to 4 weeks | 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 |
| PharmacoKinetic parameters (AUClast) | up to 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2) | up to 4 weeks | Pharmacokinetic parameters of Efepoetin alfa blood concentration after a single intravenous administration of the investigational product |
| Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC) | up to 4 weeks | Pharmacodynamic parameters of hemoglobin, reticulocyte and reticulocyte hemoglobin content after administration of the investigational product |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature and severity of adverse events | up to 4 weeks | Graded according to NCI CTCAE v5.0 |
| Immunogenicity | up to 4 weeks | Incidence of anti-drug antibodies (ADAs) relative to baseline |
| Exploratory | up to 4 weeks | Assessment or iron storage function |
Countries
South Korea
Outcome results
None listed