Clinical trial NCT03144934: Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Papillomavirus
Keywords: HPV
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.
timeFrame: 12 weeks
Secondary outcomes:
measure: Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)
timeFrame: at week 0 (Day 0) and week 4 (Day 28)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center-Kangnam
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jae Kwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: