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

NCT ID: NCT02291991

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

GX-E2

Intervention Type: DRUG

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Group B

Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (7 subjects : GX-E2, 1 subject : Placebo)

Group Type: EXPERIMENTAL

GX-E2

Intervention Type: DRUG

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Interventions

GX-E2

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Intervention Type: DRUG

GX-E2

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Intervention Type: DRUG

Other Intervention Names

GC1113; GC1113

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)
• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KyungSang Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-E2-P1

Identifier Type: -

Identifier Source: org_study_id