NCT01508988已完成1 期
A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult 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
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects, aged 18-64 inclusive
- •Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- •IOP measurement oculus uterque (OU, both eyes) < 21 mm Hg (inclusive) at screening and Day -1
- •Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1
排除标准
- •Any history of severe ocular trauma in either eye at any time
- •Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye
- •Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye
- •At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results
- •Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of the study
- •History of clinically significant drug or food allergy, positive HIV, hepatitis B or C at screening
研究组 & 干预措施
Eye drops 0.3 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops 1 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops 3 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops 10 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops 20 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops 30 µg/mL
Experimental
干预措施: ONO-9054 (Drug)
Eye drops placebo
Experimental
干预措施: ONO-9054 (Drug)
结局指标
主要结局
Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
时间窗: up to 4 days
次要结局
- 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample(up to 2 days)
- 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering(up to 2 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477Healthy VolunteersNCT02870400Regeneron Pharmaceuticals41
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT03945279Biogen49
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy VolunteersHealthy VolunteerNCT03645746Regeneron Pharmaceuticals56
进行中（未招募）
1 期
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy ParticipantsHealthyNCT05501717Alexion Pharmaceuticals, Inc.48
已完成
1 期
A Study of the Safety and Tolerability of GWP42006 in Healthy SubjectsEpilepsyNCT01918735Jazz Pharmaceuticals66