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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 30, 2019

Detailed Description

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

Interventions

  • Drug: GX-I7 or [14C] GX-I7
    • IM GX-I7 or IV/IM microdose of GX-I7

Arms, Groups and Cohorts

  • Experimental: Part 1
    • IM: GX-I7 60 µg/kg IV: [14C]-GX-I7 40 µg
  • Experimental: Part 2
    • IV: [14C]-GX-I7 40 µg
  • Experimental: Part 3
    • IM: GX-I7 60 µg/kg, [14C]-GX-I7 40 µg

Clinical Trial Outcome Measures

Primary Measures

  • Total radioactivity at feces,urine,blood to measure total recovery rate
    • Time Frame: 29 days
    • radioactivity in nCi

Participating in This Clinical Trial

Inclusion Criteria

1. Subject is willing and able to give informed consent after listening character of the clinical trial 2. Must be 19-45 years of age, inclusive 3. Weight 50-100kg, BMI 18-30kg/m2 4. 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 5. No clinical abnormality from ECG test 6. Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test) Exclusion Criteria:

1. Suspected or confirmed malignancy, or has malignancy history 2. 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 3. Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab 4. Are considering or scheduled to undergo any surgical or dental procedure during the study 5. Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months 6. Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases 7. Positive from urine drug screen or respiratory alcohol screen at medical screening 8. History of alcohol, drug, or substance abuse in the past 12 months 9. A heavy alchol consumer (>21 units/week, 1 unit = 10 g of pure alcohol) or Consumption of alcohol within 48 hours prior to hospitalization 10. 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 11. Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration 12. Do not have veins suitable for cannulation or multiple venipunctures 13. Previously donate whole blood within 60 days or component blood within 14 days 14. Excessive consumption of foods containing grapefruits 15. Any other factor that the Investigator thinks will increase subject risk with participation

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Howard Lee, Professor – Seoul National University Hospital

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