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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 16, 2017

Primary Completion Date

March 22, 2018

Study Completion Date

March 22, 2018

Conditions
Human Papillomavirus
Interventions
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.

DRUG

Placebo

This is the placebo of GX-I7 described above.

Trial Locations (4)

35015

Chungnam National University Hospital, Daejeon

03722

Yonsei University Health System, Severance Hospital, Seoul

07441

Hallym University Medical Center-Kangnam, Seoul

08308

Korea University Guro Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genexine, Inc.

INDUSTRY

NCT03144934 - Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers | Biotech Hunter | Biotech Hunter