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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04283695
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Leukopenia	Drug: GX-I7 or [14C] GX-I7	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jul 3, 2019
• Actual Primary Completion Date: Aug 30, 2019
• Anticipated Study Completion Date: May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total radioactivity at feces,urine,blood to measure total recovery rate [29 days]

   radioactivity in nCi

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital Clinical Trial Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04283695
• Other Study ID Numbers: Mab_GX_I7
• First Posted: Feb 25, 2020
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukopenia

Study Results

No Results Posted as of Feb 25, 2020