An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from baseline in best corrected visual acuity
研究概览
简要总结
This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes.
- •A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator.
- •Literate and able to orally communicate.
排除标准
- •Non-cycloplegic sphere worse than -4.75 Diopters
- •Axial length > 26 mm
- •Hyperopia worse than +1.50 Diopters
- •Anisometropia (difference of myopic power >2.00 D).
- •Astigmatism > 1.5 D.
- •Intraocular pressure > 21 mm Hg or < 6 mm Hg.
研究组 & 干预措施
SHJ002 - Maximum tolerated concentration
Maximum tolerated concentration of SHJ002
干预措施: SHJ - Maximum tolerated (Drug)
0.025% SHJ002
0.025% SHJ002 Sterile Ophthalmic Solution
干预措施: SHJ - Low concentration (Drug)
0.080% SHJ002
0.080% SHJ002 Sterile Ophthalmic Solution
干预措施: SHJ - Mid concentration (Drug)
0.25% SHJ002
0.25% SHJ002 Sterile Ophthalmic Solution
干预措施: SHJ - High concentration (Drug)
结局指标
主要结局
Change from baseline in best corrected visual acuity
时间窗: 3 days (Part 1) and 28 days (Part 2)
Change from baseline in best corrected visual acuity
Incidence of Adverse Events
时间窗: 3 days (Part 1) and 28 days (Part 2)
Incidence of Adverse Events
次要结局
未报告次要终点