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

NCT02291991 | Completed Phase 1

• 1 other identifier: GX-E2-P1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenecity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• pharmacodynamics as measured by Hemoglobin

  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

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Drug: GX-E2

Interventions

GX-E2 DRUG

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

Also known as: GC1113

Group A

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

GC1113

Study Officials

• KyungSang Yu, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 17, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

KR (1)