NCT02724254已完成2 期
A Double-blind Placebo Controlled, Randomized, Phase II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Percentage of patients with at least one local skin reaction (LSR)
研究概览
简要总结
This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged between 18 and 55 years.
- •External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
- •Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
- •Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
- •Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
- •Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
- •For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.
排除标准
- •Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
- •Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
- •Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
- •Patients with history or presence of drug or alcohol abuse.
- •Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
- •Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.
研究组 & 干预措施
AP611074 5% gel
Experimental
100 mg twice daily doses of AP611074 5% gel
干预措施: AP611074 5% gel (Drug)
Placebo
Placebo Comparator
AP611074 matching placebo gel
干预措施: AP611074 matching placebo (Drug)
结局指标
主要结局
Percentage of patients with at least one local skin reaction (LSR)
时间窗: Day 0 to Week 16
Mean plasma concentrations of AP611074-04
时间窗: Day 0 to 2 weeks post end of treatment
Number of patients experiencing adverse events
时间窗: Day 0 to Week 16
次要结局
- Reduction in the total condyloma area for lesions(Day 0 to week 16)
- Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions(Day 0 to week 16)
- Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions(Day 0 to week 16)
- Time to complete clearance(Day 0 to week 16)
研究者
研究点 (2)
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