Clinical trial NCT06490939: Clinical Trial of Efepoetin Alfa in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PharmacoKinetic parameters (Cmax)
timeFrame: up to 4 weeks
measure: PharmacoKinetic parameters (AUClast)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)
timeFrame: up to 4 weeks
measure: Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)
timeFrame: up to 4 weeks
Other outcomes:
measure: Exploratory
timeFrame: up to 4 weeks
measure: Incidence, nature and severity of adverse events
timeFrame: up to 4 weeks
measure: Immunogenicity
timeFrame: up to 4 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References: