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
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0002389
- Lead Sponsor
- Genexine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 32
1. Subject is willing and able to give informed consent after getting explanation on the clinical trial voluntarily signed informed consent form
2. Female patient between Must be 19 and 45 years of age, inclusive
3. Those who have been diagnosed with HPV infection in two tests with at least 2 weeks in between during the screening period, or have been diagnosed with HPV infection in one test during the screening period and have history of HPV infection within 6 months.
4. No clinical abnormality from result in ECG test
5. Must agree to use effective contraception (i.e., condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during study period and after the final injection of investigational drug
1. HSIL (High grade squamous intraepithelial lesion) or more severe in cervical cytological test
2. History of a known or suspected hypersensitivity, shock, or history to the investigational drugs
3. Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
4. Active infection or history of infection that required intravenous injection of antibiotics 4 weeks prior to the first administration of the investigational drug
5. Female subject unwilling to stop breastfeeding or pregnancy
6. Positive result from serology examination for human immunodeficiency
7. Major surgery within 3 months other than access surgery
8. Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
9. Participation in any clinical trial within 30 days
10. History of alcohol or drug abuse within 6 months prior to the screening
11. Any other ineligible condition at the direction of investigator that would be ineligible to participate the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety related items (Systematical / local adverse events, vital signs (blood pressure, temperature, and pulse), physical examination, laboratory test, immunogenicity, concentration of investigational drug after intravaginal administration)
- Secondary Outcome Measures
Name Time Method HPV DNA test in cervical cell