Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers

NCT03144934 | Completed Phase 1 DMC

• 1 other identifier: GX-I7M-HPV-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers

Conditions

Human Papillomavirus

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.

  Local and systemic adverse events will be assessed by Department of AIDS (Table for Grading the Severity of Adult and Pediatric Adverse Events, 2004) and Toxicity Grading Scale for Healthy Volunteers Enrolled in Preventive Vaccine Clinical Trials, respectively. Also, vital signs (blood pressure, heart rate, and body temperature), physical examination, laboratory tests, upper abdomen ultrasound, immunogenicity test, and concentration of the investigational drug in blood sample will be assessed throughout the screening and study period.

  12 weeks

Secondary Outcomes (1)

• Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)

  at week 0 (Day 0) and week 4 (Day 28)

Study Arms (2)

Administraion of investigational product

EXPERIMENTAL

* 0.25mg, 1mg, 3mg, 6mg, or 9mg (optional) of GX-I7 * 6 subjects per each cohort * twice administration with 4-week intervals

Drug: GX-I7

Administraion of placebo

PLACEBO COMPARATOR

* GX-I7 vehicle (formulation buffer) * 2 subjects per each cohort * twice administration with 4-week intervals

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

Administraion of investigational product

Placebo DRUG

This is the placebo of GX-I7 described above.

Also known as: GX-I7 vehicle (formulation buffer)

Administraion of placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject willing and able to give informed consent
• Must be ≥19 and ≤45 years diagnosed with HPV infection in two tests within screening periods or have history of HPV infection within 6 months and diagnosed with HPV infection in one test within screening periods
• No clinical abnormality from ECG test
• Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 3 months after the last dose of study drug.

You may not qualify if:

• Subject with HSIL or more severe HPV infection
• History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar drugs
• Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
• Active infection or history of infection that required intravenous injection of antibiotics 4 weeks prior to the first administration of the investigational drug
• Female subject unwilling to stop breastfeeding or pregnancy
• Positive result from serology examination for human immunodeficiency virus (HIV)
• Major surgery within 3 months other than access surgery
• Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
• Participation in any clinical study within 30 days
• History of alcohol or drug abuse within 6 months prior to the screening
• Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (4)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Hallym University Medical Center-Kangnam

Seoul, 07441, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Interventions

efineptakin alfa

Study Officials

• Jae Kwan Lee, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 9, 2017
• Study Start: February 16, 2017
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)