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

Genexine0 个研究点目标入组 32 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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

发起方

Genexine