Clinical trial NCT02291991: Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Immunogenecity
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: pharmacokinetics as measured by Cmax
timeFrame: Day1 - 29
measure: pharmacokinetics as measured by Cmax AUC(0-tlast)
timeFrame: Day1 - 29
measure: pharmacokinetics as measured by AUCing
timeFrame: Day1 - 29
measure: pharmacokinetics as measured by Tmax
timeFrame: Day1 - 29
measure: pharmacokinetics as measured by t1/2
timeFrame: Day1 - 29
measure: pharmacokinetics as measured by CL/F
timeFrame: Day1 - 29
Secondary outcomes:
measure: pharmacodynamics as measured by Hemoglobin
timeFrame: Day1 - 29
measure: pharmacodynamics as measured by Reticulocyte count
timeFrame: Day1 - 29
measure: pharmacodynamics as measured by Reticulocyte hemoglobin contents
timeFrame: Day1 - 29
measure: Safety and Tolerability of GX-E2 as checked immunogenecity
timeFrame: Day1 - 29
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KyungSang Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: