NCT03239223已完成1 期
A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
Antiva Biosciences1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
研究概览
简要总结
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 25 to 50 years old.
- •Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
- •Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
- •Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
排除标准
- •Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- •History of cancer, except basal cell or squamous cell carcinoma of the skin.
- •History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
- •Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
- •History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
研究组 & 干预措施
Dose 1 - Multiple Ascending Dose (MAD)
Experimental
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
干预措施: ABI-1968 (Drug)
Dose 2 - Multiple Ascending Dose (MAD)
Experimental
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
干预措施: ABI-1968 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
时间窗: 85 Days
Number of participants with Adverse Events related to treatment to determine MTD
次要结局
- Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.(85 Days)
- Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.(85 Days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)Cutaneous LeishmaniasisNCT00606580U.S. Army Medical Research and Development Command375
已完成
2 期
Lidocaine-prilocaine Cream on IUD Insertion PainIUD PainNCT02658773Assiut University120
已完成
2 期
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)Cervical DysplasiaCervical Intraepithelial NeoplasiaNCT02864147Yale University134
已完成
4 期
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic DermatitisDermatitis, AtopicNCT00666302Astellas Pharma Inc413
已完成
3 期
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)Acne VulgarisNCT02608450Cassiopea SpA708