Healthy
Conditions
Keywords
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenecity
Brief summary
This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.
Detailed description
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally, Immunogenecity will be evaluated to investigate antibody production.
Interventions
DRUGGX-E2
Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * Male subjects 20 to 55 years old * Adequate body weigth and BMI(19 ≤ BMI ≤ 27, 60.0kg ≤ body weigth ≤ 90.0kg) * The subject doesn't have a clinically significant abnormal laboratory value and/or clinically significant unstable medical or disease history. * Are eligible for the study hemoglobin data(12.0g/dL ≤ Hb ≤ 16.5g/dL) (Data is checked per 2 weeks within 28 days) * Adequate transferrin saturation, serum ferritin within 28 days * Adequate folate within 28 days * Adequate vitamin B12 within 28 days * Adequate WBC count (≥ 3.0 X 1000 µL) * Adequate PLT count(≥ 140 X 1000 µL) * nonsmoker or smoker smoked under 10 cigarettes a day
Exclusion criteria
* The subject has a clinically significant abnormal allergy including medical allergy. * The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease * Subject with a previous experience in i.v. administration of EPO, darbepoetin, other EPO supplying proteins, immunoglobulin and iron drugs * Subject with a hypersensitivity against EPO, darbepoetin and supplementary iron drugs * Subject with a condition of hemoglobinopathy (e.g. sickle-cell disease and thalassemia) * Subject showing following systolic and diastolic parameters at sitting position after 3 minutes of resting: lower than 90 mmHg or higher than 140mmHg of systolic blood pressure and lower than 50 mmHg or higher than 90mmHg of diastolic blood pressure * Subject with chronic and uncontrollable symptoms of inflammatory disease (e.g. rheumatoid arthritis and systemic lupous erythematousus) * Subject with the exceeding level of C-reactive protein more than 4 mg/dL before 2 weeks of IP administration * History of drug prior to screening or urine drug testing is positive (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids) * Subject who has administered with a prescribed drug and oriental or herbal medicine in 2 weeks before IP administration, and who has administered with a general pharmaceutical and vitamin in 1 week before IP administration * Subject who has enrolled in other clinical trials of IP or approved drug within 8 weeks before IP administration * Subject with a history of fever at body temperature more than 38°C in a week before IP administration * History of epileptic convulsion within 6 months * Subject who is positive in HIV, HBsAg, HCV antibody test * Subject with a regular alcohol consumption more than 21 unit, and who is unable to quit drinking during the period of clinical trial * Subject who donated or lost more than 400mL of blood within 8 weeks prior to first dose * Subject who is treated with investigational products. * Subject with a longer length of spleen more than 16cm via upper abdominal ultrasound during the screening * Subject who is considered as inappropriate for participation by Investigator based on various lab results * Subject who plans to be pregnant or at least is unable to apply authorized contraceptive methods (e.g. sterilization operation, the use of contraceptive devices)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetics as measured by CL/F | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
| pharmacokinetics as measured by Cmax AUC(0-tlast) | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
| pharmacokinetics as measured by AUCing | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
| pharmacokinetics as measured by Tmax | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
| pharmacokinetics as measured by t1/2 | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
| pharmacokinetics as measured by Cmax | Day1 - 29 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pharmacodynamics as measured by Reticulocyte count | Day1 - 29 | — |
| pharmacodynamics as measured by Reticulocyte hemoglobin contents | Day1 - 29 | — |
| Safety and Tolerability of GX-E2 as checked immunogenecity | Day1 - 29 | — |
| pharmacodynamics as measured by Hemoglobin | Day1 - 29 | Hemoglobin, Reticulocyte count, Reticulocyte hemoglobin contents |
Countries
South Korea
Outcome results
None listed