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

Genexine

Status and phase

Completed

Phase 1

Conditions

Human Papillomavirus

Treatments

Drug: Placebo

Drug: GX-I7

Study type

Interventional

Funder types

Industry

Identifiers

NCT03144934

GX-I7M-HPV-002

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

Female

Ages

19 to 45 years old

Volunteers

No Healthy Volunteers

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