To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers

Study Overview
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Brief Summary
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A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers

Detailed Description
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A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers To show ABA and Mass balance of GX-I7

Official Title
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A Phase 1, Open-labeled, Single-dose, One-sequence, One-period, 3-part Study to Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers

Conditions
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Leukopenia

Intervention / Treatment
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* Drug: GX-I7 or [14C] GX-I7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to give informed consent after listening character of the clinical trial Must be 19-45 years of age, inclusive Weight 50-100kg, BMI 18-30kg/m2 Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values No clinical abnormality from ECG test Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test) Exclusion Criteria: Suspected or confirmed malignancy, or has malignancy history Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab Are considering or scheduled to undergo any surgical or dental procedure during the study Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases Positive from urine drug screen or respiratory alcohol screen at medical screening History of alcohol, drug, or substance abuse in the past 12 months A heavy alchol consumer (>21 units/week, 1 unit = 10 g of pure alcohol) or Consumption of alcohol within 48 hours prior to hospitalization Medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration Do not have veins suitable for cannulation or multiple venipunctures Previously donate whole blood within 60 days or component blood within 14 days Excessive consumption of foods containing grapefruits Any other factor that the Investigator thinks will increase subject risk with participation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>IM: GX-I7 60 µg/kg IV: [14C]-GX-I7 40 µg | Drug: GX-I7 or [14C] GX-I7<br>* IM GX-I7 or IV/IM microdose of GX-I7<br>|
| Experimental: Part 2<br>IV: [14C]-GX-I7 40 µg | Drug: GX-I7 or [14C] GX-I7<br>* IM GX-I7 or IV/IM microdose of GX-I7<br>|
| Experimental: Part 3<br>IM: GX-I7 60 µg/kg, [14C]-GX-I7 40 µg | Drug: GX-I7 or [14C] GX-I7<br>* IM GX-I7 or IV/IM microdose of GX-I7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity at feces,urine,blood to measure total recovery rate | radioactivity in nCi | 29 days |