Phase 1 Multi Center, Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Vital sign- systolic and diastolic blood pressure
研究概览
简要总结
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The study is a double-masked, multiple- ascending dose trial and will enroll four cohorts of up to 12 subjects. Dose cohorts will receive increasing doses of AKB-9778 ophthalmic solution or vehicle-matched placebo daily for 7 days. Cohort 5 will enroll subjects with open angle glaucoma or ocular hypertension who will continue current prostaglandin therapy during the study. Cohort 5 subjects will receive the maximum tolerated dose from the previous cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged > 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in Cohorts 2-4, aged 18 to 80 years inclusive in Cohort
- •For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP between 17 and 27 mm Hg (inclusive).
- •Central corneal thickness of 480 to 600 μm, inclusive
- •For subjects in Cohort 5, diagnosis of OAG or OHT
- •For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering
排除标准
- •Diagnosis of any form of glaucoma in Cohorts 1-4
- •Clinically significant eye trauma within 6 months of screening
- •Any intraocular ophthalmic procedure within 6 months of screening
- •Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye
- •Subjects with any known chronic ocular disease (other than incipient cataract or refractive error)
- •Any condition preventing valid applanation tonometry measurement, e.g., clinically significant corneal disease, refractive surgery
- •Visual acuity (VA) worse than 20/30 in either eye, For Cohort 5 VA worse than 20/100 in either eye
研究组 & 干预措施
AKB-9778 Ophthalmic Solution
Up to 4 daily dose levels of AKB-9778 Ophthalmic Solution will be evaluated. Doses will be administered in both eyes daily for 7 days.
干预措施: AKB-9778 Ophthalmic Solution (Drug)
Vehicle Control Ophthalmic Solution
Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days.
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Vital sign- systolic and diastolic blood pressure
时间窗: Baseline to Day 7
Systolic and diastolic blood pressure in mmHg
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Baseline to Day 7
Complete blood count
时间窗: Baseline to Day 7
White blood cells with differential, hemoglobin, hematocrit and platelet count
次要结局
- AKB-9778 concentration(Baseline to Day 7)
- Intraocular pressure(Baseline to Day 7)