Clinical Trial of GX-I7 in Healthy Volunteers

October 21, 2018 updated by: Genexine, Inc.

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7 in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The subjects who are adequately eligible to attend this clinical trial via screening will be hospitalized one day prior to the injection (Day -1), administered a single dose of GX-I7 solution for subcutaneous injection, and then discharged on Day 3. After completing all scheduled tests at the visit 8 (Day 28), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 3 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 or check-in
  8. History of alcohol, drug, or substance abuse in the past 12 months
  9. 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. Any other factor that the Investigator thinks will increase subject risk with participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
GX-I7 SC 20㎍/㎏ (8 subjects) / Placebo (2 subjects)
Drug: GX-I7
Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
Other Names:
  • IL-7-hyFc
Drug: Placebo
This is the placebo of GX-I7 described above.
Other Names:
  • GX-17 vehicle (formulation buffer)
EXPERIMENTAL: Cohort 2
GX-I7 SC 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
Drug: GX-I7
Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
Other Names:
  • IL-7-hyFc
Drug: Placebo
This is the placebo of GX-I7 described above.
Other Names:
  • GX-17 vehicle (formulation buffer)
EXPERIMENTAL: Cohort 3
GX-I7 IM 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
Drug: GX-I7
Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
Other Names:
  • IL-7-hyFc
Drug: Placebo
This is the placebo of GX-I7 described above.
Other Names:
  • GX-17 vehicle (formulation buffer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of adverse events including laboratory abnormality after Single Subcutaneous (SC) Injection of GX-I7
Time Frame: 4 weeks
Adverse events after injections.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Assessment: Maximum serum concentration (Cmax)
Time Frame: 4 weeks
PK Parameters to be assessed by single SC administration will be Cmax.
4 weeks
Pharmacokinetic (PK) Assessment: Time to Cmax (Tmax)
Time Frame: 4 weeks
PK Parameters to be assessed by single SC administration will be Tmax.
4 weeks
Pharmacokinetic (PK) Assessment: apparent terminal half-life (t1/2)
Time Frame: 4 weeks
PK Parameters to be assessed by single SC administration will be t1/2. t1/2=lnf(2)/λz (λz: invariable for speed of loss obtained from linear regression analysis in logarithmic plot of terminal phase)
4 weeks
Pharmacokinetic (PK) Assessment: Area under the curve from zero to last time of measurable concentration after single administration by trapezoidal rule (AUCt)
Time Frame: 4 weeks
PK Parameters to be assessed by single SC administration will be AUC (0-inf).
4 weeks
Pharmacokinetic (PK) Assessment: Area under the curve from zero to infinity (AUC(0-inf))
Time Frame: 4 weeks
PK Parameters to be assessed by single SC administration will be AUC(0-inf).
4 weeks
Pharmacodynamic (PD) Assessment: Emax of Absolute Lymphocyte Count (ALC)
Time Frame: 8 weeks
PD parameters will be determined by Emax of ALC, which will be compared with peripheral baseline.
8 weeks
Pharmacodynamic (PD) Assessment: Area Under The Effect-Time Curve Up To Last Quantifiable Effect (AUEClast) of ALC
Time Frame: 8 weeks
PD parameters will be determined by AUEClast of ALC, which will be compared with peripheral baseline.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory PD (PD) assessment: Change of the ratio of immune cells
Time Frame: 4 weeks
Change of the ratio of immune cells by flow cytometer
4 weeks
Exploratory PD (PD) assessment: T cells in lymphocytes by flow cytometer
Time Frame: 4 weeks
Cluster of Differentiation 4 (CD4) T and Cluster of differentiation 8 (CD8) T in lymphocytes by flow cytometer
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genexine, Inc.

Investigators

  • Principal Investigator: Howard Lee, M.D, Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2016

Primary Completion (ACTUAL)

January 20, 2017

Study Completion (ACTUAL)

June 2, 2018

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GX-I7-HV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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