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

NCT04283695 | Unknown Early Phase 1

• 1 other identifier: Mab_GX_I7
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Leukopenia

Outcome Measures

Primary Outcomes (1)

• Total radioactivity at feces,urine,blood to measure total recovery rate

  radioactivity in nCi

  29 days

Study Arms (3)

Part 1

EXPERIMENTAL

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

Drug: GX-I7 or [14C] GX-I7

Part 2

EXPERIMENTAL

IV: \[14C\]-GX-I7 40 µg

Drug: GX-I7 or [14C] GX-I7

Part 3

EXPERIMENTAL

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

Drug: GX-I7 or [14C] GX-I7

Interventions

GX-I7 or [14C] GX-I7 DRUG

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

Part 1; Part 2; Part 3

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Leukopenia

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: February 25, 2020
• Study Start: July 3, 2019
• Primary Completion: August 30, 2019
• Study Completion: May 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

KR (1)