Clinical Trial of Efepoetin Alfa in Healthy Subjects
- Registration Number
- NCT06490939
- Lead Sponsor
- Genexine, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caucasian Efepoetin Alfa Single-dose Asian Efepoetin Alfa Single-dose
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of