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HealthyPhase 1NCT02860715

Clinical Trial of GX-I7 in Healthy Volunteers

A Phase 1 study testing GX-I7 in people with Healthy, run by Genexine, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GX-I7
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSouth Korea
Study dates
11 Jul 2016to 2 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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 3 months
  • Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases
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  • Positive from urine drug screen or respiratory alcohol screen at medical screening or check-in
  • History of alcohol, drug, or substance abuse in the past 12 months
  • 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
  • Any other factor that the Investigator thinks will increase subject risk with participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
GX-I7, Placebo
Keywords
Safety, Pharmacodynamics, Dose-Limiting Toxicity (DLT), Immunogenicity, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-I7Drug

    Also called IL-7-hyFc

    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.

  • PlaceboDrug

    Also called GX-17 vehicle (formulation buffer)

    This is the placebo of GX-I7 described above.

Study groups in NCT02860715
Study groupRoleWhat they receive
Cohort 1ExperimentalGX-I7 SC 20㎍/㎏ (8 subjects) / Placebo (2 subjects)
Receives: Drug: GX-I7; Drug: Placebo
Cohort 2ExperimentalGX-I7 SC 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
Receives: Drug: GX-I7; Drug: Placebo
Cohort 3ExperimentalGX-I7 IM 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
Receives: Drug: GX-I7; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of adverse events including laboratory abnormality after Single Subcutaneous (SC) Injection of GX-I7

    Adverse events after injections.

    Measured: 4 weeks

Secondary outcomes (7)

  1. Pharmacokinetic (PK) Assessment: Maximum serum concentration (Cmax)

    PK Parameters to be assessed by single SC administration will be Cmax.

    Measured: 4 weeks

  2. Pharmacokinetic (PK) Assessment: Time to Cmax (Tmax)

    PK Parameters to be assessed by single SC administration will be Tmax.

    Measured: 4 weeks

  3. Pharmacokinetic (PK) Assessment: apparent terminal half-life (t1/2)

    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)

    Measured: 4 weeks

  4. Pharmacokinetic (PK) Assessment: Area under the curve from zero to last time of measurable concentration after single administration by trapezoidal rule (AUCt)

    PK Parameters to be assessed by single SC administration will be AUC (0-inf).

    Measured: 4 weeks

  5. Pharmacokinetic (PK) Assessment: Area under the curve from zero to infinity (AUC(0-inf))

    PK Parameters to be assessed by single SC administration will be AUC(0-inf).

    Measured: 4 weeks

  6. Pharmacodynamic (PD) Assessment: Emax of Absolute Lymphocyte Count (ALC)

    PD parameters will be determined by Emax of ALC, which will be compared with peripheral baseline.

    Measured: 8 weeks

  7. Pharmacodynamic (PD) Assessment: Area Under The Effect-Time Curve Up To Last Quantifiable Effect (AUEClast) of ALC

    PD parameters will be determined by AUEClast of ALC, which will be compared with peripheral baseline.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion20 Jan 2017
  4. Study completion2 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860715
Sponsor's protocol ID
GX-I7-HV-001
Status last verified
Oct 2018
First submitted
15 Jun 2016
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kang MC, Choi DH, Choi YW, Park SJ, Namkoong H, Park KS, Ahn SS, Surh CD, Yoon SW, Kim DJ, Choi JA, Park Y, Sung YC, Lee SW. Intranasal Introduction of Fc-Fused Interleukin-7 Provides Long-Lasting Prophylaxis against Lethal Influenza Virus Infection. J Virol. 2015 Dec 9;90(5):2273-84. doi: 10.1128/JVI.02768-15.

    PubMed 26656713

  • Seo YB, Im SJ, Namkoong H, Kim SW, Choi YW, Kang MC, Lim HS, Jin HT, Yang SH, Cho ML, Kim YM, Lee SW, Choi YK, Surh CD, Sung YC. Crucial roles of interleukin-7 in the development of T follicular helper cells and in the induction of humoral immunity. J Virol. 2014 Aug;88(16):8998-9009. doi: 10.1128/JVI.00534-14. Epub 2014 Jun 4.

    PubMed 24899182

  • Ahn SS, Jeon BY, Park SJ, Choi DH, Ku SH, Cho SN, Sung YC. Nonlytic Fc-fused IL-7 synergizes with Mtb32 DNA vaccine to enhance antigen-specific T cell responses in a therapeutic model of tuberculosis. Vaccine. 2013 Jun 12;31(27):2884-90. doi: 10.1016/j.vaccine.2013.04.029. Epub 2013 Apr 23.

    PubMed 23624092

  • Martin CE, van Leeuwen EM, Im SJ, Roopenian DC, Sung YC, Surh CD. IL-7/anti-IL-7 mAb complexes augment cytokine potency in mice through association with IgG-Fc and by competition with IL-7R. Blood. 2013 May 30;121(22):4484-92. doi: 10.1182/blood-2012-08-449215. Epub 2013 Apr 22.

    PubMed 23610371

  • Nam HJ, Song MY, Choi DH, Yang SH, Jin HT, Sung YC. Marked enhancement of antigen-specific T-cell responses by IL-7-fused nonlytic, but not lytic, Fc as a genetic adjuvant. Eur J Immunol. 2010 Feb;40(2):351-8. doi: 10.1002/eji.200939271.

    PubMed 19950168

  • Park SH, Song MY, Nam HJ, Im SJ, Sung YC. Codelivery of IL-7 Augments Multigenic HCV DNA Vaccine-induced Antibody as well as Broad T Cell Responses in Cynomolgus Monkeys. Immune Netw. 2010 Dec;10(6):198-205. doi: 10.4110/in.2010.10.6.198. Epub 2010 Dec 31.

    PubMed 21286380

  • Lee SW, Choi D, Heo M, Shin EC, Park SH, Kim SJ, Oh YK, Lee BH, Yang SH, Sung YC, Lee H. hIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects. Clin Transl Sci. 2020 Nov;13(6):1161-1169. doi: 10.1111/cts.12800. Epub 2020 May 20.

    PubMed 32339447

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GX-I7 in people with Healthy, run by Genexine, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of adverse events including laboratory abnormality after Single Subcutaneous (SC) Injection of GX-I7 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02860715, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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