NCT07717918已完成1 期
A Phase 1B Study of BL1332 on Capsaicin-Induced Ocular Pain in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Ocular pain severity assessed by numeric pain rating scale (NPRS)
研究概览
简要总结
Single center, double-masked study of BL1332 on Capsaicin-Induced Ocular Pain in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥ 18 to ≤ 65 years of age.
- •In good health, as assessed at Screening by the Investigator from past medical history, physical examination (abbreviated), and laboratory tests.
- •Does not wear contact lenses, or is willing to refrain from wearing contact lenses for the duration of the study.
排除标准
- •Women of childbearing potential or non-vasectomized males with partners of childbearing potential are not eligible unless they are using an effective method of contraception and agree to use an effective method of contraception until at least 30 days after study treatment.
- •Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of IP, safe participation in this study, or confound the assessment of safety or efficacy.
- •Unwilling or unable to comply with the study protocol.
研究组 & 干预措施
BL1332 eye drops
Active Comparator
干预措施: BL1332 eye drops (Drug)
BL1332 Placebo eye drops
Placebo Comparator
干预措施: BL1332 Placebo eye drops (Drug)
结局指标
主要结局
Ocular pain severity assessed by numeric pain rating scale (NPRS)
时间窗: Assessed 5 seconds post-capsaicin dose
NPRS scale 0 to 10, with higher score reflecting worse pain
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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