Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects (GX-E2-P1)

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

This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GX-E2

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Principal Investigator: KyungSang Yu, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Pharmacodynamics; Immunogenecity
• Other Study ID Numbers: GX-E2-P1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No