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

Human Papillomavirus Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Human Papillomavirus

• NCT number: NCT03144934
• Study type: Interventional
• Source: Genexine, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2017
• Completion date: March 22, 2018