KCT0000586已完成未知
A single center, open-label, dose-escalating, Phase ? study to evaluate the safety of GX-188E administered by electroporation (EP) in DNA-based therapeutic vaccine for patients with Cervical Intraepithelial Neoplasia grade 3 (CIN 3)
Gegexine0 个研究点目标入组 9 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Female
入选标准
- •1)Female aged between 20 and 50 years
- •2)Those who promised not to get pregnant from the participation to the study until the first F/U visit (VF1)
- •3)Histologically confirmed HPV-16 or HPV-18 associated Cervical Intraepithelial Neoplasia grade 3 (CIN 3)
- •4)Those who voluntarily signed informed consent form
排除标准
- •1)Pregnant or lactating women
- •2)Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
- •3)Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug (Day 0)
- •4)Prior immunotherapy against HPV
- •5)Administration of any blood products within 3 months prior to the screening visit
- •6)Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
- •7)Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
- •8)Prior participation in any clinical trial within 30 days prior to the screening visit
- •9)Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
- •10)Past history of epilepsy or convulsion within 2 years prior to the screening visit
- •11)At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
- •12)The thickness of skin fold covering deltoid muscles, intended injection sites, >40mm
- •13)Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
- •14)Any history of severe adverse drug events or severe allergic diseases
- •15)Sinus bradycardia whose resting heart rate < 50beats/min.
- •16)Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
- •17)Artificial implants or metallic implants
- •18)Abnormal electrocardiography (ECG) including arrhythmia
- •19)Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
研究者
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