NCT00765427已完成1 期
A Phase 1a, Repeat-Dose Escalation Study to Investigate the Safety and Tolerability of a 7-Day Repeated Dose of Retinoid QLT091001 in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- QLT Inc.
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
研究概览
简要总结
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate
排除标准
- •Subjects with any clinically important abnormal physical finding at screening.
- •Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
- •Female subjects who are either pregnant or lactating.
结局指标
主要结局
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
时间窗: 30 days
次要结局
- Adverse events(30 days)
研究者
研究点 (1)
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