Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03144934
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT03144934
Study Brief:
Protocol Section:
NCT03144934