A Randomized, Double-Masked, Vehicle-Controlled, Single-Center Phase 1 Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of 0.25%, 0.5% and 1.0% VVN461 Ophthalmic Solution
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety outcome
研究概览
简要总结
This is a single-center, double-masked, randomized, vehicle-controlled study conducted in China in adult healthy subjects
详细描述
This is a Phase I, randomized, double-masked, vehicle-controlled study to evaluate the safety, tolerability and pharmacokinetics of 0.25%, 0.5% and 1.0% VVN461 Ophthalmic Solution in healthy male and female volunteers in China.
The study consisted of a screening period (D-7 to D-1), a baseline visit (D-1), a single-dose period (D1), QID multi-dose period (D2 to D5), six times daily multi-dose period (D6 to D9), discharge (D10), and a follow-up/EOS (D16,+1D). During the single-dose period, subjects will receive one drop of VVN461 eye drops (0.25%, 0.5%, or 1.0%) or vehicle in the study eye. For the multi-dose period, subjects will receive one drop of VVN461 eye drop (0.25%, 0.5% or 1.0%) or vehicle in the study eye four or six times a day. PK blood samples will be collected before and after dosing at D1, D5 and D9.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 50 years at the time of signing the informed consent form.
- •Males weighing ≥ 50.0kg and females ≥ 45.0kg; and with a body mass index (BMI = weight/height squared) of 19-26 kg/m2 (including thresholds).
- •Best-corrected visual acuity (BCVA) ≥ 0.8 (standard logarithmic scale) in both eyes; intraocular pressure of 11-21 mmHg (including threshold) in both eyes; and slit-lamp examination of the anterior segment of the eye and funduscopic examination (funduscopic photographs) with no significant abnormality or an abnormality judged by the investigator to be not clinically significant.
- •No clinically significant medical history of the liver, kidneys, gastrointestinal tract, nervous system, respiratory system (e.g., asthma, exercise-induced asthma, chronic obstructive pulmonary disease), hematological and lymphatic system, musculoskeletal system, rheumatological immunity, psychiatric abnormalities and metabolic abnormalities
- •Physical examination, vital signs, 12-lead electrocardiogram and laboratory tests at screening are within normal values or the abnormalities are not clinically significant.
排除标准
- •Known hypersensitivity or contraindications to the study drug or its components
- •Anatomical anomalies in either eye
- •History of eye surgery (other than blepharoplasty) or laser treatment of the eye (including keratoconus) in either eye
- •Blepharoplasty on either eye within 3 months prior to screening
- •History of subchoroidal or vitreous injection in either eye
- •Infectious eye disease, immunological eye disease, inflammatory eye disease or ocular trauma in either eye within three months prior to screening;
- •Use of topical ophthalmic medications (including artificial tears, proprietary drops and OTC ophthalmic medications) in either eye within 1 month prior to screening
- •Using contact lens in either eye within 14 days prior to screening or unable to discontinue the use of contact lens during the study
- •A history of eye disease such as glaucoma, corneal opacity, corneal degeneration, corneal dystrophy, uveitis, fundopathy, or other ophthalmic disease in either eye, which is assessed by the investigator to be contraindicated for participation in the trial.
研究组 & 干预措施
VVN461, 1.0%
VVN461 Ophthalmic Solution, 1.0%
干预措施: VVN461 Ophthalmic Solution 1.0% (Drug)
VVN461, 0.5%
VVN461 Ophthalmic Solution, 0.5%
干预措施: VVN461 Ophthalmic Solution 0.5% (Drug)
VVN461, 0.25%
VVN461 Ophthalmic Solution, 0.25%
干预措施: VVN461 Ophthalmic Solution 0.25% (Drug)
Vehicle
VVN461 Ophthalmic Solution, Placebo
干预措施: VVN461 Ophthalmic Solution Placebo (Drug)
结局指标
主要结局
Safety outcome
时间窗: Baseline to Day 16
Incidence of adverse events
次要结局
- Time to maximum blood level(Maximum seen over Days 1 to 9)
- Area under the curve of blood levels until last observation(Integrated over Days 1 to 9)
- Area under the curve of blood levels extrapolated to infinity(Integrated over Days 1 to 9)
- Half life of drug in blood(Integrated over Days 1 to 9)