A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
Dose escalation 3+3 design with accelerated titration 4 dose levels
详细描述
This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male, 18 to 65 years of age, Female subjects of child-bearing potential must be non-pregnant
- •Able to provide voluntary written informed consent
- •Normal ocular function (BCVA 20/20) and anatomy
- •Available for and agree to all study procedures including inpatient monitoring, follow-up visits, sample collection, study treatment administration
- •Body mass index 18.5 to 35 kg/m^2
- •Demonstrated ability to self-administer eye drops
排除标准
- •Clinically significant co-morbid ocular conditions
- •Co-morbid medical conditions requiring treatment
- •Active ocular infection within the 2 weeks prior to Day 1
- •Active non-ocular infection requiring antibiotics within the 2 weeks prior to Day 1
- •Use of systemic or dermatological cytotoxic chemotherapy within the 1 month prior to Day 1
- •Planned contact lens use during the study period
- •Use of any investigational product within the 1 month prior to Day 1
- •Corticosteroid use in the 1 month prior to Day 1
- •Major surgery within the 3 months prior to Day 1
- •History of dependence on alcohol or drugs of abuse
- •History of intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance
- •Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
研究组 & 干预措施
TTHX1114 Dose Level 1
TTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
干预措施: TTHX1114(NM141) Ophthalmic Solution (Drug)
TTHX1114 Dose Level 2
TTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
干预措施: TTHX1114(NM141) Ophthalmic Solution (Drug)
TTHX1114 Dose Level 3
TTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
干预措施: TTHX1114(NM141) Ophthalmic Solution (Drug)
TTHX1114 Dose Level 4
TTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
干预措施: TTHX1114(NM141) Ophthalmic Solution (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 28 days
Important Medical Events (ocular) related to study treatment
次要结局
未报告次要终点