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

Leukopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04283695
• Other study ID #: Mab_GX_I7
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 3, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: May 1, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukopenia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity at feces,urine,blood to measure total recovery rate	radioactivity in nCi	29 days