NCT04208087已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Maximum Plasma Concentration (Cmax) for SI-722
研究概览
简要总结
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ≥18 and ≤80 years of age
- •A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
排除标准
- •Urinary tract infection ≤30 days
- •Treatment with intravesical therapy ≤60 days
- •Treatment with any opioid therapy ≤7 days
- •History of bladder hydrodistension ≤3 months
- •Has cancer or a past history of any cancer ≤5 years
- •Body mass index (BMI) ≥40 kg/m2
研究组 & 干预措施
SI-722
Experimental
干预措施: SI-722 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for SI-722
时间窗: 4 weeks
SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.
次要结局
未报告次要终点
研究者
研究点 (5)
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