A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.
详细描述
Laquinimod administered as an oral capsule formulation has previously been studied in neurodegenerative and autoimmune diseases. The clinical side effect profile of orally administered laquinimod is well-characterized based on this previous experience.
This trial will establish a safe and tolerated dose of laquinimod when administered as an eye-drop formulation following single ascending dose (SAD) and multiple ascending dose (MAD) administrations. There are four planned groups in the SAD-part of the study which will enroll 28 participants, if all dose levels are explored. The subsequent MAD-part of the study will enroll another 28 participants.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Laquinimod - Single Ascending Doses
One single dose of laquinimod eye-drops. There are up to four planned dose levels.
干预措施: Laquinimod (Drug)
Placebo - Single Ascending Doses
One single dose of placebo eye-drops.
干预措施: Placebo (Drug)
Laquinimod - Multiple Ascending Doses
Eye-drops administered once daily for 14-21 days. There are up to two planned dose levels. The first dose level will be defined in the SAD-part of the study.
干预措施: Laquinimod (Drug)
Placebo - Multiple Ascending Doses
Eye-drops administered once daily for 14-21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: For 7 days post-dose
Type, frequency, seriousness, severity and relationship to treatment
次要结局
- Investigator-reported eye-toxicities - Corneal fluorescein staining(At screening visit (baseline) and immediately after the intervention)
- Investigator-reported eye-toxicities - Slit lamp examination(Pre-dose (baseline) and immediately after the intervention)
- Investigator-reported eye-toxicities - Intraocular pressure(At screening visit (baseline) and immediately after the intervention)
- Investigator-reported eye-toxicities - Funduscopy in mydriasis(At screening visit (baseline) and immediately after the intervention)
- Participant-reported eye-toxicities(Pre-dose (baseline) and immediately after the intervention)
- Investigator-reported eye-toxicities - BCVA(Pre-dose (baseline) and immediately after the intervention)
- Trough plasma concentration of laquinimod at steady-state(On the last three days of multiple dosing)
- Peak plasma concentration of laquinimod(Over up to 21 days after (last) dose)
- Time to peak plasma concentration of laquinimod(Over up to 21 days) after (last) dose)
- Systemic exposure of laquinimod(Over up to 21 days after (last) dose)