Clinical Trial of GX-I7 in Healthy Volunteers

NCT02860715 | Completed Phase 1 DMC

• 1 other identifier: GX-I7-HV-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Safety; Pharmacodynamics; Dose-Limiting Toxicity (DLT); Immunogenicity; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  Adverse events after injections.

  4 weeks

Secondary Outcomes (7)

• Pharmacokinetic (PK) Assessment: Maximum serum concentration (Cmax)

  4 weeks

• Pharmacokinetic (PK) Assessment: Time to Cmax (Tmax)

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Other Outcomes (2)

• Exploratory PD (PD) assessment: Change of the ratio of immune cells

  4 weeks

• Exploratory PD (PD) assessment: T cells in lymphocytes by flow cytometer

  4 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

GX-I7 SC 20㎍/㎏ (8 subjects) / Placebo (2 subjects)

Drug: GX-I7; Drug: Placebo

Cohort 2

EXPERIMENTAL

GX-I7 SC 60㎍/㎏ (8 subjects) / Placebo (2 subjects)

Drug: GX-I7; Drug: Placebo

Cohort 3

EXPERIMENTAL

GX-I7 IM 60㎍/㎏ (8 subjects) / Placebo (2 subjects)

Drug: GX-I7; Drug: Placebo

Interventions

GX-I7 DRUG

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.

Also known as: IL-7-hyFc

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

This is the placebo of GX-I7 described above.

Also known as: GX-17 vehicle (formulation buffer)

Cohort 1; Cohort 2; Cohort 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 3 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 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (7)

• 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.

  PMID: 26656713 BACKGROUND

• 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.

  PMID: 24899182 BACKGROUND

• 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.

  PMID: 23624092 BACKGROUND

• 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.

  PMID: 23610371 BACKGROUND

• 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.

  PMID: 19950168 BACKGROUND

• 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.

  PMID: 21286380 BACKGROUND

• 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.

  PMID: 32339447 DERIVED

MeSH Terms

Interventions

efineptakin alfa

Study Officials

• Howard Lee, M.D, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: August 9, 2016
• Study Start: July 11, 2016
• Primary Completion: January 20, 2017
• Study Completion: June 2, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)