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

NCT ID: NCT04283695

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2020-05-01

Brief Summary

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

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

Conditions

Leukopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1

IM: GX-I7 60 µg/kg IV: \[14C\]-GX-I7 40 µg

Group Type: EXPERIMENTAL

GX-I7 or [14C] GX-I7

Intervention Type: DRUG

IM GX-I7 or IV/IM microdose of GX-I7

Part 2

IV: \[14C\]-GX-I7 40 µg

Group Type: EXPERIMENTAL

GX-I7 or [14C] GX-I7

Intervention Type: DRUG

IM GX-I7 or IV/IM microdose of GX-I7

Part 3

IM: GX-I7 60 µg/kg, \[14C\]-GX-I7 40 µg

Group Type: EXPERIMENTAL

GX-I7 or [14C] GX-I7

Intervention Type: DRUG

IM GX-I7 or IV/IM microdose of GX-I7

Interventions

GX-I7 or [14C] GX-I7

IM GX-I7 or IV/IM microdose of GX-I7

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Howard Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Mab_GX_I7

Identifier Type: -

Identifier Source: org_study_id