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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Administraion of investigational product
- 0.25mg, 1mg, 3mg, 6mg, or 9mg (optional) of GX-I7
- 6 subjects per each cohort
- twice administration with 4-week intervals
干预措施: GX-I7 (Drug)
Administraion of placebo
- GX-I7 vehicle (formulation buffer)
- 2 subjects per each cohort
- twice administration with 4-week intervals
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.
时间窗: 12 weeks
Local and systemic adverse events will be assessed by Department of AIDS (Table for Grading the Severity of Adult and Pediatric Adverse Events, 2004) and Toxicity Grading Scale for Healthy Volunteers Enrolled in Preventive Vaccine Clinical Trials, respectively. Also, vital signs (blood pressure, heart rate, and body temperature), physical examination, laboratory tests, upper abdomen ultrasound, immunogenicity test, and concentration of the investigational drug in blood sample will be assessed throughout the screening and study period.
次要结局
- Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)(at week 0 (Day 0) and week 4 (Day 28))