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

NCT ID: NCT03144934

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2018-03-22

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

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.

Conditions

Human Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: 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.

Administraion of placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This is the placebo of GX-I7 described above.

Interventions

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.

Intervention Type: DRUG

Placebo

This is the placebo of GX-I7 described above.

Intervention Type: DRUG

Other Intervention Names

IL-7-hyFc; GX-I7 vehicle (formulation buffer)

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Kwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Hallym University Medical Center-Kangnam

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-I7M-HPV-002

Identifier Type: -

Identifier Source: org_study_id