Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects
- Registration Number
- NCT02291991
- Lead Sponsor
- Genexine, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A GX-E2 Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (1 subject : GX-E2, 1 subject : Placebo) Subjects in group A will be injected drug, So we observe safety. After three days, Subject in group B will be injected drug. Group B GX-E2 Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (7 subjects : GX-E2, 1 subject : Placebo)
- Primary Outcome Measures
Name Time Method 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 Cmax 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 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 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"
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of GX-E2 as checked immunogenecity Day1 - 29 pharmacodynamics as measured by Hemoglobin Day1 - 29 Hemoglobin, Reticulocyte count, Reticulocyte hemoglobin contents
pharmacodynamics as measured by Reticulocyte hemoglobin contents Day1 - 29 pharmacodynamics as measured by Reticulocyte count Day1 - 29
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of