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

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

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

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus
• Intervention / Treatment: Drug: GX-I7; Drug: Placebo

Detailed Description

The subjects who are adequately eligible to attend this clinical trial via screening will be assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After completing scheduled tests at the visit 6 (Day 14), 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): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health system, Severance Hospital
  • Seoul, Korea, Republic of, 07441
    • Hallym University Medical Center-Kangnam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administraion of investigational product; 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; 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
Placebo Comparator: Administraion of placebo; GX-I7 vehicle (formulation buffer); 2 subjects per each cohort; twice administration with 4-week intervals	Drug: Placebo; This is the placebo of GX-I7 described above.; Other Names: GX-I7 vehicle (formulation buffer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)	Perform liquid-based cytology after each injections	at week 0 (Day 0) and week 4 (Day 28)

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Principal Investigator: Jae Kwan Lee, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

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: HPV
• Other Study ID Numbers: GX-I7M-HPV-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No