Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind Placebo Controlled, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 After Single Intravenous Administration in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GX-E2
* Drug: GX-E2


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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. | Drug: GX-E2<br>* Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.<br>* Other names: GC1113;|
| Experimental: Group B<br>Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (7 subjects : GX-E2, 1 subject : Placebo) | Drug: GX-E2<br>* Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.<br>* Other names: GC1113;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics as measured by Cmax | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 
| pharmacokinetics as measured by Cmax AUC(0-tlast) | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 
| pharmacokinetics as measured by AUCing | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 
| pharmacokinetics as measured by Tmax | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 
| pharmacokinetics as measured by t1/2 | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 
| pharmacokinetics as measured by CL/F | Measures Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2 | Day1 - 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamics as measured by Hemoglobin | Hemoglobin, Reticulocyte count, Reticulocyte hemoglobin contents | Day1 - 29 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenecity