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

Genexine, Inc.1 site in 1 country10 target enrollmentNovember 2014

ConditionsHealthy

InterventionsGX-E2

DrugsGX-E2

Overview

Phase: Phase 1
Intervention: GX-E2
Conditions: Healthy
Sponsor: Genexine, Inc.
Enrollment: 10
Locations: 1
Primary Endpoint: pharmacokinetics as measured by Cmax AUC(0-tlast)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

January 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Genexine, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

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

Arms & Interventions

Group A

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.

Intervention: GX-E2