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

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

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 Overview

• Status: Unknown
• Conditions: Leukopenia
• Intervention / Treatment: Drug: GX-I7 or [14C] GX-I7

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

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Leukocyte Disorders; Leukopenia
• Other Study ID Numbers: Mab_GX_I7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No