NCT03144934

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-16
• Primary completion: 2018-03-22
• Completion: 2018-03-22
• First posted: 2017-05-09
• Last updated: 2018-10-23

Locations

4 sites across 1 country: South Korea